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Results | PMC9869378 |
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Participant flow | A total of 346 participants who completed eligibility screening between February 2019 and March 2020, were randomised to VP or PV sequence (173 each). Of these, valid HbA1c data were obtained in 261 participants after vildagliptin and 237 participants after pioglitazone, with 203 participants completing both assessments (Flow diagram of the study participants included in this analysis. | PMC9869378 |
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Baseline data | diabetes | OBESE, DIABETES | The mean (SD) for age was 57.5 (10.9) years, HbA1c 75 (12) mmol/mol), [9% 1.1)], diabetes duration 9 (6) years; 41% of participants were women, 55% were Māori and/or Pacific (Baseline demographics and clinical characteristics.Data are n (%) or mean (SD). OHTG refers to obese (BMI ≥ 30kg/m*Other medication includes acarbose in 10 cases and dapagliflozin in 3 cases.Descriptive data at baseline and after each treatment.*Questions contained in the DTSQ are shown in | PMC9869378 |
Outcomes | deaths, strokes, Triglycerides reduced | ADVERSE EVENTS, MYOCARDIAL INFARCTION, STROKES | Overall, a greater mean decrease in HbA1c was observed after pioglitazone than after vildagliptin treatment (adjusted mean difference -4.9mmol/mol [-0.5%], 95%CI -6.3, -3.5; p < 0.0001) (The estimated medication effects on HbA1c and its interaction with ethnicity (primary outcome analysis).ITT, intention to treat; PP, per protocol; CI, confidence interval.The estimated medication effects on patient outcomes and its interaction with patient groups.All valid patient data collected at baseline and after each medication treatment were used in the analysis; missing data were not imputed.*Questions contained in the DTSQ are shown in A treatment difference in HbA1c response was observed in participants with OHTG (-5.9mmol/mol [0.54%]) compared with those without OHTG (-1.2mmol/mol [0.11%]), with an estimated interaction effect of -4.7mmol/mol [0.43%], 95%CI -8.1, -1.4, p=0.005 (Mean weight after pioglitazone was higher than after vildagliptin treatment, with an adjusted mean difference of 1.6kg (95%CI [1.1, 2.0]; p<0.0001). There was no interaction in weight change response to pioglitazone versus vildagliptin by ethnicity or OHTG status (DTSQ scores at baseline and after each treatment.*Derived from the sum of responses to question 1 and questions 4-8 each rated on a scale from 0 to 6, with a high score (maximum 36) representing high treatment satisfaction.Hepatic enzymes, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) were lower after pioglitazone but remained unchanged after vildagliptin (difference p<0.0001). The difference in hepatic enzymes after pioglitazone vs vildagliptin, did not differ significantly by Māori and Pacific ethnicity or OHTG. Triglycerides reduced after pioglitazone compared with after vildagliptin (mean difference -0.3mmol/L, p<0.0001), with no interaction by ethnicity or OHTG grouping. HDL-C increased more after pioglitazone than after vildagliptin (+0.1mmol/L, p<0.0001).At the final trial visit, 257 participants indicated their preferred medication: 98 (38%) preferred pioglitazone, 87 (34%) preferred vildagliptin, and 72 (28%) indicated either no preference (n=62) or neither (n=10). No differences in medication preference were found by ethnicity, or OHTG strata after adjusting for their treatment sequence (PV or VP), the change in HbA1c, weight and DTSQ score between two treatments.There were 15 serious adverse events: 3 deaths (2 strokes and 1 myocardial infarction) and 12 hospitalisations. None were deemed to be due to the trial medication by an independent data safety monitoring committee. | PMC9869378 |
Discussion | obesity, T2D, myocardial infarction, weight gain, 4.7mmol/mol greater reduction, diabetes | OBESITY, MYOCARDIAL INFARCTION, ADVERSE EVENTS, DISEASE, INSULIN RESISTANCE, TYPE 2 DIABETES, DIABETES | This multicentre, two-way, randomised crossover trial showed that the glucose-lowering response to pioglitazone relative to vildagliptin was not different between people of Māori or Pacific ethnicity and other New Zealand ethnicities. However, there was a significant interaction in relative glucose-lowering by OHTG status, with 4.7mmol/mol greater reduction in HbA1c by pioglitazone relative to vildagliptin among those with OHTG. Those without OHTG had similar glucose lowering to each medication. Importantly, both treatments generated similar treatment satisfaction scores although there was greater weight gain and greater improvement in lipids and liver enzymes after pioglitazone than vildagliptin. No severe adverse events were directly related to these treatments.While people of Māori or Pacific ethnicity had higher prevalence of OHTG, such ethnicity grouping did not predict altered glucose lowering response to pioglitazone versus vildagliptin. Within Māori and Pacific populations, there is genetic heterogeneity in risk and aetiology of T2D. A genetic variant (In contrast to rosiglitazone, which is no longer used due to its associated increased risk of myocardial infarction and overall mortality (The lack of interaction of reduction in liver enzymes or lipids after pioglitazone with baseline OHTG is interesting. One explanation is that the glucose lowering action of pioglitazone is mediated by ligand binding to nuclear receptor PPARG which are most abundant in adipocytes and hence greater in people with obesity (Comparative medication glucose response data from this crossover study design provides evidence-based understanding of how patients would respond if they were to switch from one medication to another. While this is something that happens frequently in diabetes care, there is very limited clinical data about how patients’ glycaemic control changes when this happens or which medication they prefer. In addition, several consensus reports describe that when making treatment decisions for patients with type 2 diabetes it is important to consider not only the efficacy and safety of each medication, but also patient preference. This open-label cross-over study provides the added value of patient preference outcomes between pioglitazone and vildagliptin in the real-world setting. The protocol for a three-way crossover study including a DPP4 inhibitor, thiazolidinedione and a SGLT2 inhibitor has been described, which will provide further information on stratification of glucose response to three diabetes medications by routine clinical features ascertained at baseline (A key limitation of this trial was the low follow up rate resulting in only 203 participants with valid HbA1c data after both treatments. Some of this related to difficulties encountered during the pandemic in obtaining a timely HbA1c result at the end of each study medication treatment phase and in conducting in person assessments. This is unlikely to have introduced any retention bias as each person contributed their own comparative data for both medications. Furthermore, the analysis was conducted with and without imputation on the primary analysis population, to test the robustness of the findings. Secondly, the open-label nature of the trial was selected for lower cost and complexity, which may have introduced observer and participant bias, but increased external validity. Thirdly, the crossover trial design might have led to the inappropriate estimation of the risk of weight gain with each medication, although the sensitivity analysis showed no significant carryover effect. The crossover design was selected as the best method to test differential glucose-lowering responses using HbA1c as the primary outcome measure between two diabetes medications in different patient subgroups (It is well recognised that overall glucose lowering effects of pioglitazone are typically greater than vildagliptin. The important finding of this study is that a superior glucose-lowering response to pioglitazone versus vildagliptin is observed mainly in those with OHTG. Whilst OHTG is more prevalent in those of Māori and Pacific ethnicity, the glucose-lowering response was not significantly different by such ethnicity group in a multi-ethnic New Zealand population. This has several clinical implications. Firstly, these findings suggest that ethnicity is not a sufficient proxy for stratified medicine for pioglitazone and vildagliptin in T2D. Rather, clinical markers of insulin resistance that are routinely available in clinical practice such as BMI and triglyceride levels are able to predict whether superior glucose lowering response to pioglitazone relative to vildagliptin is expected. The recent progress in better defining novel T2D subtypes based on underpinning disease mechanisms such as age at diabetes diagnosis, GAD antibodies, C-peptide and genetic factors need to be explored for their utility in predicting other stratified glucose lowering responses ( | PMC9869378 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC9869378 |
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Ethics statement | The studies involving human participants were reviewed and approved by NZ Health and Disability Ethics Committee. The patients/participants provided their written informed consent to participate in this study. | PMC9869378 |
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Author contributions | PRS | RM designed the trial. YJ was responsible for the statistical analysis of the data. TRM was responsible for the genetic analysis plan. ML designed the population-specific genetic variant panel. TM assisted with genetic analysis of the data. RM and PRS obtained funding. RB, RY, RT-C, KS, GD, KAM, RD, PC, AM, NN, FK, JH, BO-W, and RP were responsible for trial implementation and data acquisition. RB and RM wrote the first draft of this manuscript and RM handled the revisions. All authors reviewed the manuscript and approved the final version for submission. | PMC9869378 |
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Acknowledgments | Diabetes | ADVERSE EVENTS, DIABETES | We are grateful to all the participants who took part in this study. We acknowledge Yiping Zou and Stacey Ruru for assisting with the data collection for this trial. We are grateful for the helpful input from John Baker in the planning of this trial; pharmacist Dale Griffiths and the team from zoom pharmacy who dispensed and couriered trial medication to participants; Chris McKinlay and the study database design and support team. We are grateful to Manish Khanolkar and Geoff Braatvedt for providing adjudication for serious adverse events in this trial. We thank the trial staff at each site, particularly Hinemoa McLelland (Research Nurse) for Ngāti Porou Hauora site; Mele Vaka (Research Nurse) from Tongan Health Society; Melissa Peterson (Research Nurse) from Te Hiku Hauora; Gillian Stonelake (Research GP) for Waikato; Diane Caveney and Liz Walker (Research Nurses) from Middlemore Clinical Trials; Trish Harry (Research Co-ordinator) from Diabetes Foundation Aotearoa. We acknowledge Riku Takei for assistance with the PC analysis. | PMC9869378 |
Conflict of interest | RP, Nordisk | Authors RP and RM have received speaking honoraria from Lilly, Boehringer Ingelheim, Astra Zeneca, Sanofi, Novo Nordisk, also Novartis (RM) and Inova pharmaceuticals (RP). RP is a member of the Lilly, Novo Nordisk and Dexcom New Zealand advisory boards. Authors KAM, RD, PC were employed by Ventures/Pinnacle Incorporated, a primary health care organisation which has no relevant commercial or financial relationships.The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9869378 |
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Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC9869378 |
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Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC9869378 |
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References | PMC9869378 |
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Background | cord injury, traumatic cervical SCI, Traumatic | Traumatic cervical spinal cord injury (SCI) results in reduced sensorimotor abilities that strongly impact on the achievement of daily living activities involving hand/arm function. Among several technology-based rehabilitative approaches, Brain-Computer Interfaces (BCIs) which enable the modulation of electroencephalographic sensorimotor rhythms, are promising tools to promote the recovery of hand function after SCI. The “DiSCIoser” study proposes a BCI-supported motor imagery (MI) training to engage the sensorimotor system and thus facilitate the neuroplasticity to eventually optimize upper limb sensorimotor functional recovery in patients with SCI during the subacute phase, at the peak of brain and spinal plasticity. To this purpose, we have designed a BCI system fully compatible with a clinical setting whose efficacy in improving hand sensorimotor function outcomes in patients with traumatic cervical SCI will be assessed and compared to the hand MI training not supported by BCI. | PMC10662594 |
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Methods | traumatic cervical SCI | This randomized controlled trial will include 30 participants with traumatic cervical SCI in the subacute phase randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and the hand MI training not supported by BCI. Both interventions are delivered (3 weekly sessions; 12 weeks) as add-on to standard rehabilitation care. A multidimensional assessment will be performed at: randomization/pre-intervention and post-intervention. Primary outcome measure is the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory sub-score. Secondary outcome measures include the motor and functional scores of the GRASSP and other clinical, neuropsychological, neurophysiological and neuroimaging measures. | PMC10662594 |
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Discussion | traumatic | We expect the BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maximize recovery of arm functions in traumatic cervical subacute SCI. This study will generate a body of knowledge that is fundamental to drive optimization of BCI application in SCI as a top-down therapeutic intervention, thus beyond the canonical use of BCI as assistive tool. | PMC10662594 |
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Trial registration | cord injury | Name of registry: DiSCIoser: improving arm sensorimotor functions after spinal cord injury via brain-computer interface training (DiSCIoser). Trial registration number: NCT05637775; registration date on the ClinicalTrial.gov platform: 05-12-2022. | PMC10662594 |
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Keywords | PMC10662594 |
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Background | Traumatic, stroke, traumatic SCI, injury between stroke, ischaemia, trauma | CERVICAL LESIONS, STROKE, ISCHAEMIA, SPINAL CORD | Traumatic Spinal Cord Injury (SCI) represents a devastating condition for physical and social well-being [Over the last decade, the epidemiology of traumatic SCI has progressively changed with an increase in cervical lesions, particularly at C1-C4 levels [Technological advances have led to the development of novel interventions aimed at improving upper arm function in individuals with SCI [Current rehabilitation approaches after traumatic SCI mainly consist of intensive training of lost or impaired function that is assumed to increase the activity-dependent plasticity of spared circuits and thus leading to functional improvements [In the effort of encouraging the top-down contribution of supraspinal sensorimotor signal in SCI rehabilitation, the Brain-Computer Interface (BCI) technology [The main evidence for the efficacy of non-invasive BCIs as neurorehabilitation tools stems from clinical trials conducted on stroke population, in which BCI-assisted MI training was shown to be effective in promoting brain plasticity, resulting in improved hand motor function [Moreover, despite differences in the usual mechanism of injury between stroke (ischaemia) and SCI (trauma), rehabilitation approaches could successfully translate in similar recovery of sensorimotor functions between ischaemic and traumatic SCI [For this reason, it could be assumed that monitoring and modulating the central nervous system plasticity occurring after a SCI is a key factor in shaping clinically valuable top-down rehabilitation strategies with the aim to recover sensorimotor function after SCI. In the DiSCIoser study, we propose to use a goal-oriented action imagination training, controlled, and objectified by means of a BCI system. As such, the BCI based motor imagination training would engage the sensorimotor system and thus facilitate neuroplasticity to eventually optimize upper limb sensorimotor functional recovery in patients with SCI during the subacute phase when brain and spinal plasticity is at its peak. | PMC10662594 |
Aim and hypotheses | stroke, traumatic cervical SCI, traumatic | STROKE | The “DiSCIoser'' study is a randomized controlled trial (RCT) designed to provide evidence for a significant improvement of hand sensorimotor function induced by a BCI-assisted MI training in patients with traumatic SCI.Based on our previous findings on the efficacy of BCI-supported MI training in patients with stroke [Accordingly, the aim of the RCT will be to determine whether the BCI-assisted MI (BCI-MI) training, administered by means of a BCI system fully compatible with a clinical setting, is superior to a non-BCI assisted MI (Control-MI) training in improving hand sensorimotor function outcomes in individuals with traumatic cervical SCI admitted to the ward “Centro Spinale” at Fondazione Santa Lucia for their standard rehabilitation care. | PMC10662594 |
Methods/design | hand movements | SECONDARY, BLIND | A total cohort of 30 participants will be enrolled and randomized in a single centre, single blind RCT to investigate the efficacy of BCI-MI training for hand movements, delivered during the subacute phase of SCI (hospitalization period). The primary and secondary outcome measures collected from participants assigned to BCI-MI training will be compared with those of participants who receive an equivalent dose of MI training without BCI support (Control-MI).All procedures conducted in this trial follow national institutional ethical standards and the Helsinki Declaration. The study protocol and related procedures were approved by the institutional review board: the Independent Ethical Committee of the Fondazione Santa Lucia (FSL), I.R.C.C.S., Rome, Italy (protocol CE/PROG.884 15-12-2020). The trial was registered on the clinicaltrials.gov in 05-12-2022 (trial registration number: NCT05637775). | PMC10662594 |
Study design | ASIA | SPINAL CORD | The DiSCIoser trial is designed as a randomized, controlled, assessors blinded single-centre trial with 2 parallel groups with 1:1 allocation ratio. The study flow is illustrated in Fig. DiSCIoser Randomized Controlled Trial summary. All Spinal Cord Injury (SCI) patients admitted to the Spinal Unit at Fondazione Santa Lucia IRCCS will be screened (T enrol) for eligibility according to Inclusion/Exclusion criteria. The evaluation according to the International Standards for Neurological Classification of SCI (ISNCSCI) ASIA Impairment Scale (AIS) and the predicted mean Upper Extremity Motor Score (UEMS) recovery will be used for eligibility. Eligible participants will be presented with the Informed Consent and recruited (30 participants). Clinical, neuropsychological, neurophysiological and neuroimaging assessments will be performed before (T pre) and after (T post) the interventionThe primary outcome is the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) somatosensory sub-score [
Standard protocol items as recommended for Interventional Trials (SPIRIT)The study is presented according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [ | PMC10662594 |
Sample size | ASIA | The sample size was calculated on the hypothesis that experimental intervention (BCI-MI training) is superior in improving the primary outcome measure. Based on preliminary findings in the Upper Extremity Motor Scores (UEMS) from the International Standards for Neurological Classification of SCI (ISNCSCI) ASIA Impairment Scale (AIS) [ | PMC10662594 |
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Inclusion/exclusion criteria | traumatic brain injury, epilepsy, ASIA, traumatic, psychiatric, impulsivity, neurological deficits, cognitive comorbidities | EPILEPSY | The specific Inclusion and Exclusion criteria are listed below:Inclusion criteria:age between 18 and 70 years,current hospitalization at FSL site for rehabilitation care,subacute traumatic cervical SCI (30–90 days after the event),classification according to ISNCSCI ASIA Impairment Scale A-D,lesion level between C1 and T1,predicted average UEMS recovery of less than 40/50 [Exclusion criteria:other conditions (present or previous) potentially affecting sensorimotor function of the upper extremities,significant traumatic brain injury,history of epilepsy or previous neurological deficits,psychiatric or cognitive comorbidities involving motor planning problems or impulsivity (unable to follow commands),inability to give informed consent and understand training requirements,concurrent enrolment in other clinical research trials focusing on specific unconventional treatments targeting upper limb function. | PMC10662594 |
Assessments | PMC10662594 |
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Primary | Changes from pre- | PMC10662594 |
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Secondary | humour, Pain, pain | SECONDARY, SPINAL CORD | The secondary outcome measures are the changes from pre- muscle strength: the GRASSP motor score of bilateral arms that ranges from 0 (maximum impairment) to 50 (normal) for each side [muscle tone: the Modified Ashworth Scale (MAS) for the muscle tone assessment of upper and lower limbs [pain: the International SCI Pain Basic Dataset (ISCIBPDS) for pain assessment; a pain-intensity, rating from 0 to 10, quantifies pain impact on activities daily living, humour, and sleep functions [functional ability: the GRASSP prehension ability ranging from 0 to 12 for each side and prehension execution ranging from 0 to 20 for each side; the Spinal Cord Injury Independence Measure (SCIM) self-care section score ranges from 0 (maximum impairment) to 20 (independence) [Other specified secondary outcome measures will be extracted from neurophysiological, neuroimaging, neuropsychological and user experience assessments (see below). | PMC10662594 |
Neurophysiological assessment | This includes:the Motor Evoked Potentials (MEPs) to evaluate the changes in corticospinal tract integrity. MEPs will be recorded from the bilateral Abductor Digiti Minimi (ADM, for the upper limbs) and Abductor Hallucis (AH, for the lower limbs) muscles by following the methodology reported in [the Somatosensory Evoked Potentials (SSEPs) to evaluate the ascending sensory pathways. SSEPs will be recorded according to clinical standards, as briefly reported below. Electrical stimulation will be delivered to the median (upper limbs) and tibial (lower limbs) nerves (at motor threshold or 4 times sensory threshold, when applicable). Responses will be recorded at the Erb point (N9), cervical cord (N13) and scalp (N20) for the upper limbs and at lumbar cord (N22) and scalp (P40) for the lower limbs via bipolar derivations by means of surface electrodes, bandpass filtered between 30–3000 Hz and averaged (at least 2 averaged responses of minimum 100 stimuli each, according to patients’ collaboration and recording conditions – signal to noise ratio) [the high-density EEG recordings to evaluate the neurophysiological substrates of the experimental intervention efficacy at Each recording session will consist of (i) four minutes of EEG recording at rest (closed and opened eyes), (ii) four runs during the MI tasks (MI session), (iii) four runs during the finger tapping task (FT session) whether the participant can perform the task.Each MI session will consist of 4 runs, 40 trials each. Each run will consist of 2 tasks: i) hand kinesthetic MI [Changes of the motor relevant oscillatory activity will be measured as significant changes in the Power Spectral Density (PSD) maps (details in [As for the FT, the session will consist of 4 runs, 30 trials each. In each trial the participant will attempt the execution of the index finger tapping movement with his dominant hand assessed as in [ | PMC10662594 |
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Neuroimaging assessment | head and neck coil | The neuroimaging protocol is derived from Cohen-Adad et al. [All scans will be performed at FSL Neuroimaging Unit on a high-performance 3 T scanner (Siemens Magnetom Prisma) equipped with a 64-channel head and neck coil and a 32-channel spine array, after 2Scans will be collected in both experimental and control groups at | PMC10662594 |
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Neuropsychological and user experience assessment | The Neuropsychological assessment at Finally, the user experience assessment of the technology-based training [at each single training session: before starting an adapted version of the Questionnaire for Current Motivation (QCM) [at the first and last training session: the National Aeronautics and Space Administration Task Load Index (NASA-TLX) [at the end of last training session: the System Usability Scale (SUS) [ | PMC10662594 |
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Randomization procedure and methods | The random allocation sequence of participants to experimental (BCI-MI training) or control (Control-MI training) intervention groups will be generated by using Matlab (The MathWorks Inc, Natick, Massachusetts, USA, release 2019a).The randomization sequence will be stratified by age (2 categories: ≤ 50 years old and > 50 years old) [ | PMC10662594 |
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Intervention | PMC10662594 |
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Dosage of intervention training | ADVERSE EVENTS, ADVERSE EFFECTS | Both BCI-MI and Control-MI training will be completed in 12 weeks with a weekly frequency of 3 sessions per week, lasting 45 min. Treatment adherence is set at 12 of the 36 intervention training sessions. We do not expect the BCI-MI and Control-MI interventions to cause adverse effects (non-invasive procedure; no drug-administration; no adverse events [ | PMC10662594 |
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BCI-assisted motor imagery training (BCI-MI, experimental intervention) | SPINAL CORD | An all-in-one BCI-supported MI training station (Fig. DiSCIoser BCI station. The Brain-Computer Interface training station developed for patients with Spinal Cord Injury to practice the kinaesthetic motor imagery of hand closing and opening in a close-loop condition. The system is equipped with a laptop, a commercial wireless EEG/EMG system and a screen for the ecological feedback to the participant. The ecological feedback is delivered by means of a custom software program that provides for (personalized) visual representation of the participant’s own hands. The screen for the feedback is adjustable in height and tilt to adapt to use in wheelchair or bed. The participant in the photo filled out the photo release consent formThe feedback that participants receive, i.e., their own hand opening or closing in the virtual environment, will be controlled by the BCI control features. They are those relevant, significant frequency/spatial changes of the EEG signals related to the MI task. The control features will be extracted through offline analysis of the MI-related EEG data collected at A semiautomatic, physiologically driven EEG feature selection method, GUIDER algorithm [ | PMC10662594 |
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Motor imagery training without BCI support (Control-MI, control intervention) | The Control-MI training will be implemented under the same conditions as the experimental intervention (BCI-MI training). Specifically, the station (Fig. | PMC10662594 |
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Training sessions | During training sessions, all participants will be seated on a comfortable chair (or on their wheelchair) in a dimly lit room with their hands and forearms resting under the BCI station screen (Fig. Participants will be instructed by the therapists to perform the kinesthetic MI of both hands movements either closing or opening in separate runs randomly ordered. Each training session will consist of 4 runs (20 trials each). In the case of BCI-MI training, each trial will consist of constant baseline period of 4 s and MI task period of maximally 10 s in case of unsuccessful trial, whereas for the Control-MI training the trial length is fixed and randomly choose in the range 4-6 s. In both intervention trainings, EEG data will be collected from 16 EEG electrodes, assembled on an electrode cap according to an extension of the 10–20 International System (ground: left mastoid). Electrode positions will cover the bilateral sensorimotor area (FC3, FC1, FCz, FC2, FC4, C3, C1, Cz, C2, C4, CP3, CP1, CPz, CP2, CP4, Pz). For each participant in BCI-MI group the individual significant EEG features (extracted as described in | PMC10662594 |
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Statistical analysis | PMC10662594 |
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Primary analyses | Baseline characteristics will be described by summary statistics for each group (experimental and control intervention). Differences between groups at baseline The primary analysis will be performed in per protocol (PP) population on GRASSP somatosensory score changes between | PMC10662594 |
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Secondary analyses | SECONDARY | All secondary outcomes will be compared between groups. T-test for independent samples and non-parametric tests will be used for continuous and categorical data, respectively. Further explorative analyses will be carried out on primary and secondary outcomes in subgroups of participants identified by strata used in randomization procedure. The statistical methods adopted for primary and secondary analyses will be used. All analyses will be under the expert supervision of the partner SAP. | PMC10662594 |
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Data collection and management | CRF | CRF | An ad hoc CRF is implemented for all type and timing assessments.Specifically, the CRF will consist of two sections:i) the “Baseline and Randomization Section” which will contain each participant demographic, neurological and clinical data and all data collected for the screening section including the Informed Consent, the assigned randomized treatment, and the assessment before intervention (ii) the “Outcome and Training Section” which will not include data on assigned experimental treatment but will contain all the outcome collected in each training session and during the assessment after intervention (A specific standard operating procedure including time schedule, and instruction for management and compilation of the CRF will be used. All study staff responsible for outcome assessment (neurologists, neuropsychologists, neurophysiologists, therapists, neuroimaging researchers and other researchers involved) and training (therapists and EEG technicians) will be trained on procedures to ensure validity and reliability of trial data collection. | PMC10662594 |
Confidentiality | Confidentiality and Privacy will be managed according to Italian National Law.Personal data are regarded as strictly confidential. Original paper CRFs containing study data are stored at FSL and subjected to all GDPR (UE 2016/679) security regulation and backup as clinical/medical records. Data are entered using participant unique study codes (pseudo-anonymization). The access to all study files is restricted to FSL staff involved in the study. The BCI station system records EEG/EMG data from each participant for each training session; data will be stored by unique study code only. | PMC10662594 |
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Trial monitoring | Database collection within and between Experimental and Control intervention group will be monitored and the trial responsible will be alerted if any deviation occurs. Any modifications to the protocol which may impact on the conduct of the study, including changes of study objectives, study design, participant population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment will be agreed upon by the principal investigator and approved by the Ethics Committee prior to implementation and notified to the National Ministry of Health (sponsor). | PMC10662594 |
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Dissemination of results | Media | Main results will be subjected to publications in scientific peer-reviewed journals; results will be also presented at clinical neuroscience and/or Neuroengineering (Society for Neuroscience conference; BCI international conference; IEEE; National Society for Neurorehabilitation) conferences. Media and public outreach are planned. | PMC10662594 |
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Discussion | Traumatic cervical SCI, long-term disability | Traumatic cervical SCI may lead to long-term disability for which cost-effective rehabilitation options are critically needed. The DiSCIoser study aims at providing evidence for the clinical/neurophysiological efficacy of BCI-based intervention to promote meaningful cortical sensorimotor plasticity and eventually maximize recovery of arm functions in subacute cervical SCI. This study will generate a body of knowledge that is fundamental to drive optimization of BCI application in SCI as a top-down therapeutic intervention (taking advantage of brain plasticity), thus beyond the canonical BCI use as assistive tool (i.e., neuroprosthetic controller). | PMC10662594 |
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Acknowledgements | We would like to acknowledge the contribution of the following members of the project team: Neurophysiology Technicians Marco Secci, Fondazione Santa Lucia, IRCCS, Rome, Italy; Giorgio Tartaglia, Fondazione Santa Lucia, IRCCS, Rome, Italy; Giovanni Nicolai, Fondazione Santa Lucia, IRCCS, Rome, Italy. Research Staff Chiara Ercolano, Fondazione Santa Lucia, IRCCS, Rome, Italy. Administrative Staff Maria Frammartino, Fondazione Santa Lucia, IRCCS, Rome, Italy | PMC10662594 |
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Authors’ contributions | DM | DM in collaboration with GS and FC led the study conceptualization, design and application for funding. DM is the grant holder and manages the trial. FP is responsible for the clinical trial and data interpretation; FC manages the design and implementation of the BCI technology; EC is responsible for BCI technology implementation; JT and EC provide leadership in the design and implementation of the advanced biosignal processing, statistical plan and data interpretation. AB is in charge for all neuropsychological and behavioural assessment; AR provides advice on user experience assessment; FT (Tamburella) is responsible for all clinical/functional evaluation of SCI participants; ML and GS (Serratore) perform clinical/functional evaluation of patients. FG supervises the development and validation of ad hoc spinal cord neuroimaging acquisition protocol and the SCI data analysis. FT is in charge for the brain neuroimaging data analysis. All authors have provided critical review of the manuscript and have given final approval to this version. | PMC10662594 |
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Funding | FOUNDER | This project is funded by the Italian National Ministry of Health (MoH) under the programme Ricerca Finalizzata 2019 (grant # RF-2019-12369396), after a peer-reviewed process. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the founder MoH, that had no role in the design of this study and will not have any role during its execution, data analysis and interpretation and dissemination of decision results. | PMC10662594 |
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Availability of data and materials | Not applicable. | PMC10662594 |
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Declarations | PMC10662594 |
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Ethics approval and consent to participate | The study protocol and related procedures are approved by the institutional review board, the Independent Ethical Committee of the Fondazione Santa Lucia, IRCCS, Rome, Italy ( | PMC10662594 |
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Consent for publication | Not applicable. | PMC10662594 |
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Competing interests | The authors declare that they have no competing interests. | PMC10662594 |
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References | PMC10662594 |
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1. Introduction | Unequal opportunities and constricting sociocultural norms are inimical to gender equity and development. Curbs and controls at household and community level often disallow women to pursuit their goals for a healthy and dignified living [Boosting investments in social sector (mainly health and education) and physical infrastructure such as roads, information technology, water and sanitation etc. are important for increasing female participation in economic activities [In view of such intricacies, various national and international organizations are piloting alternative strategies to promote gender equity and empowerment across socio-economically diverse and resource-poor settings [Notable is the case of the Personal Advancement & Career Enhancement (P.A.C.E.) curriculum designed by Gap Inc. in 2007 –a widely referred PYD model across settings [The PACE curriculum, however, offers considerable scope for adaptations to meet the wide range of skill development requirements for youth and adolescents in developing countries [The intervention was piloted during 2019–21. As part of the initiative, adolescent girls were mobilized in small groups and were trained on various life skills in domains related to women empowerment, employability skills, and adolescent health and nutrition. The pilot focused on strengthening self-reliance of vulnerable adolescent girls so as to enable them to enter the workforce with strong life skills. Against this background, this paper specifically evaluates the impact of the TARA initiative on improving indicators related to self-efficacy and empowerment of adolescent girls for realizing their goals and aspirations. The analyses are based on data from a two-arm cluster randomized controlled design. Before proceeding with the analysis, a brief note on the TARA initiative is in order. | PMC10624310 |
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2. TARA pilot | Transformative Action for Rural Adolescents (TARA) pilot is an 18-month intervention launched in November 2019 in Rohtas district of Bihar with funding support from Bill and Melinda Gates Foundation (BMGF) and GAP Inc. PCI in coordination with ICRW and Gap Inc. customized the PACE curriculum for the intervention to be consistent with local context and needs of the focus group. The initial contextualizing of PACE++ curriculum and training material on life skills including gender and empowerment, self-efficacy, employability, entrepreneurship, and health and nutrition was done by PCI. The process entailed redesigning of the modules in a simple and easy way to understand The TARA pilot was implemented in two selected blocks of Rohtas district in Bihar. The pilot mobilized a total of 1205 adolescent girls (initially organized in 47 adolescent groups) and trained them on various aspects such as empowerment, employability, adolescent health and nutrition. The average attendance of adolescents in the PACE++ sessions was 86%. Prior to community roll-out, the training facilitators and supervisors also went through an induction training for improving their understanding about the project and also their ability to deliver the PACE++ curriculum. The training involved both classroom teaching (theory and practice) as well as field-based learning for comprehending session delivery in community settings. The introductory module relied on description of the core concept and encouraged discussion on the subject through use of videos on stories and stereotypes. This served as ice-breaking sessions to allow greater interaction between the adolescent girls and the community facilitators. For mobilization purposes, the PCI team made household visits for rapport building and information sharing about the TARA program. Each module was delivered only after trainings of the community facilitators which included theory sessions, group practice sessions and also field based piloting and learning for appropriate delivery of the sessions. The sessions were primarily conducted during the weekends at convenient timings to facilitate greater participation. Overall, the intervention aimed at 100 hours of direct and indirect contact with the adolescents through module sessions, club activities including sharing of information and materials on the various modules. The monitoring of the intervention was done by the project team at the district and the block level with a quality assurance checklist developed to review the conduct of the session. Feedback to community facilitators was also provided based on the monitoring to enhance efficiency of the facilitators and consequently improve training outcomes.The village-level organizations (VO) and self-help group (SHG) forums (JEEViKA groups under the State Rural Livelihood Mission (SRLM) in Bihar) were also involved in this initiative. Given the vast network of SRLM, there was a high probability of engaging adolescents through active engagement with the SRLM network. In particular, the JEEViKA staff and cadres were oriented along with village organizations referred to as the Social Action Committee (SAC) regarding the rationale and objectives of the TARA project. The self-help group members as part of the JEEViKA were sensitized for gender equity and women empowerment concerns to motivate greater participation of adolescents from their household and neighborhood. The out-of-school adolescents were also approached through Nonetheless, it is worth mentioning that the TARA pilot was not devoid of the disruptions caused due to the COVID-19 pandemic. This affected the planned activities and necessitated some re-designing of the project strategy to connect with the adolescent groups. In particular, the size of the adolescent groups was reduced from 20–25 members to 10–15 members per group. This implied requirements of additional time and human resources to ensure delivery of the adapted PACE curriculum. Also, there was continuous effort to provide support and motivation, through online channels, to enable the adolescent groups to face the challenges posed by the pandemic. PCI initiated several activities (such as drawings, poems, writing essays, motivational stories etc.) for de-stressing and prevention from COVID-19.With some improvements in COVID-19 situation and lockdown relaxation, the TARA pilot field activities were re-started in October 2020. During the post-COVID period, participation and leadership abilities among adolescent girls was encouraged through celebration of international girl child day (11 | PMC10624310 |
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3. Data and methods | PMC10624310 |
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3.1 Data | The impact evaluation is based on the baseline and endline survey data collected by the PCI team. A two-arm (intervention and comparison groups) cluster randomized controlled design was used based on two rounds of representative quantitative cross-sectional surveys with adolescent girls (15–19 years). The baseline survey was conducted during November 2020 to January 2021 whereas the end of the project survey was carried out during January 2022. The sample size for the evaluation is derived based on the assumption of observing a 10-percentage point change in critical indicators between intervention and comparison arms after the intervention with 80% power and 95% confidence of interval. The basic sample size for each arm is calculated to be 385 which further adjusted for the cluster design approach. In particular, 24 clusters per arm is required based on the assumption of a between-cluster variation of 0.25 along with the intent to interview 48 respondents per cluster. Accordingly, a total sample of 2304 adolescent girls (1152 each in intervention and comparison group) for the baseline and endline survey is finalized.All the inhabited villages (128) under the two selected blocks of the district are included for randomization. However, villages with less than 100 households or with high school are removed before randomization for ensuring adequacy of eligible sample. A total of 12 villages from each Block are randomly assigned to the two arms (intervention and comparison). The sampling frame for adolescent girls was developed based on mapping and listing operations for identifying eligible in the selected villages. The exercise is repeated for endline survey. Further, from each village a sample of 48 adolescent girls is randomly selected for both baseline and endline surveys. The baseline sample comprised of 2327 adolescent girls (1122 and 1205 in comparison and intervention areas, respectively) and endline sample of 2033 adolescent girls (1040 and 993 in comparison and intervention areas, respectively). However, within the intervention area, 618 adolescent girls reported regular participation in TARA project activities and they constitute the final analytical sample for the intervention group.The survey was conducted by a team of trained field investigators (females) using structured interview schedules that was pre-tested in a different district of the state. The inclusion criteria is as follows: unmarried adolescent girls (15–19 years) who are usual residents of the village and are willing to participate in the survey. Parental consent (both verbal and written) was also sought before approaching the adolescent girls for the interview. The interview schedule collected information on socioeconomic background of the respondents along with information on the core domains related to empowerment, employment, gender equity and health and nutrition. However, the data does not include any information which could reveal the identity of the participant. | PMC10624310 |
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3.2 Outcome measures | Core to the TARA’s programmatic approach is an evidence-based, gender-integrated life skills training and mentoring program, called Personal Advancement & Career Enhancement (P.A.C.E.) that addresses five core domains. The impact across these five domains of empowerment, employment and adolescent health and nutrition is assessed through the following measures: a) gender equity attitudes, b) diet and nutrition, c) self-esteem, d) self-efficacy and e) employee roles and responsibilities. The items used for each domain measures are available in S1 Table in | PMC10624310 |
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3.3 Correlates | Participation of the adolescent girls in the community activities under the TARA intervention is the main explanatory variable (S2 Table in | PMC10624310 |
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3.4 Statistical and econometric analysis | Descriptive statistics is provided for the outcome measures and the key explanatory variables ( | PMC10624310 |
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Background characteristics of the sample from control and intervention areas. | PMC10624310 |
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4. Results | The background characteristics of the intervention and comparison group across baseline and endline period is similar (The mean domain specific scores for the comparison and intervention group have increased between the baseline and endline period ( | PMC10624310 |
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Dietary intake from various food groups (based on 24-hour recall) and practice of minimum dietary diversity (%) in comparison and intervention groups. | PMC10624310 |
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Logistic regression (odds ratio) and Poisson regression (incidence rate ratio) for higher domain scores (top two quintiles) for comparison and intervention groups. | REGRESSION | Note:***, ** and * denotes p-value significance at 1%, 5% and 10%, respectively.The models are adjusted for age of the adolescent, schooling status, maternal and paternal education, household size, household occupation, family type, social group, poverty status, household construction material and household assets-based wealth quintile.The bottom panel of The results for the socioeconomic correlates from the adjusted logistic and Poisson regression are reported in S4, S5 Tables in The DID analysis confirms a significant impact of the program on the exposed participants ( | PMC10624310 |
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5. Discussion | anxiety, anemia, micronutrient deficiency | EVENTS, ANEMIA | This study evaluates the impact of delivering PACE++ curriculum for adolescent girls in community settings of rural Bihar. Based on the quasi-experimental study design, the study focused on domains related to gender attitudes, empowerment and dietary practices. The five salient findings of the study are as follows. First, TARA intervention had a positive impact on domain scores of intervention group comprising of adolescent girls who participated in all or most of program meetings and events. Second, the DID and PSM analyses confirm that the impact are specifically significant for the domains of attitudes toward gender equity norms, nutritional knowledge and understanding of employee related rights and responsibilities. Third, the effect size–as discerned through Cohen’s d–is of policy interest as all the domain scores show small to medium size program impact on the intervention group. Fourth, the intervention group demonstrated a positive change in dietary diversity practices whereby consumption from five or more food groups increased significantly over the intervention period. Fourth, maternal education and household wealth status have an independent influence on domain scores. In particular, maternal education is found to have significant association with empowerment related scales of self-esteem and self-efficacy. Household wealth status has a positive bearing on expected score of dietary practices. Finally, the expected domain scores of school-going adolescent girls is higher than those who have discontinued formal education.The study, however, is not devoid of limitations. First, during endline about two-third of the intervention area sample reported greater exposure to the program and was treated as the intervention group. This exposure-based attrition of sample may bias significance of program impact across domain scores. The adopted sampling approach, however, was necessary to check for overall program participation and to ensure that the sample was drawn randomly from the community and was not necessarily restricted to the program participants to discern broader implications of the program. Nevertheless, the analysis focused only on regular participants to estimate the magnitude of the impact. Second, the construction of the domain scores relied on established scales for the domains related to gender equity (GEM scale) and empowerment (self-esteem and self-efficacy scale). The scale for diet and nutrition apply well-established dietary diversity indicators and knowledge of most widely prevalence micronutrient deficiency (anemia). Whereas in the absence of relevant scale for employment related indicators, the items reflecting employee rights and responsibilities was utilized that provide a balance between awareness of employee duties and being informed regarding basic rights to safeguard employees from exploitation. This also suggests a need for developing valid and reliable scale for adolescents to assess the effect of like-skills training on employability in developing country contexts [Life skills–particularly soft skills related to self-efficacy, communication and leadership—are inextricably linked to equity and empowerment whose relevance increases manifold for women and girls across the developing world [The TARA intervention aimed at leveraging the PACE curriculum and delivering it in a rural community setting that has wide policy relevance in the Indian context. Given the large scale of the informal sector, there might be limited work platforms to provide such training modules for adolescent girls. The SHG platforms that are supported by the government provide an important avenue to empower adolescent girls, develop their resilience and support their aims and aspirations [The program impact size of the intervention is of policy interest as it demonstrates possibility of improving adolescent well-being through outreach based on community platforms. The effect size as discerned by Cohen’s d is encouraging enough to be considered for wider scale up of such initiatives using existing platforms such as JEEViKA and other self-help group and adolescent forums. The effect size is also comparable to similar to other adolescent girl programmes delivered through school-based initiatives [The program impact of TARA intervention is driven by a sound theory of change rooted in the positive youth development framework [It is worth noting that the impact of the intervention on domain scores pertaining to self-esteem and self-efficacy is relatively small. This finding is partly associated with higher baseline scores on these indicators whereas greater improvements in self-esteem are noted especially when the initial scores are lower [Before concluding, it is also important to outline the lessons learnt from program intervention during the pandemic period. The direct engagement with TARA groups immediately alerted the wide sense of fear and anxiety among adolescents that manifested in psychosocial and mental health concerns. The impact could be disproportionately on adolescent girls from economically unprivileged background. The COVID-19 protocols also implied that all efforts were counselling and information sharing were to be through digital mediums and its efficacy can be a challenge for those lacking access to mobile devices and internet. This also curtailed the program effect as the results demonstrate greater benefits for those who were regular participants. Such impact, however, was unavoidable and similar concerns are widespread across other remote and rural settings of India that have weak IT infrastructure as well as poor means for digital communication [ | PMC10624310 |
6. Conclusion | ADVERSE EFFECTS | The TARA intervention contributed to the development of the strategies for engaging and empowering adolescent girls through augmenting health and nutrition issues in the widely used PACE curriculum and also implementing this in community-based settings. Both the changes are extremely important as adolescent well-being cannot be discussed in isolation with health and nutrition concerns and also that reaching out to these in rural settings warrants a community centric platform as school settings may have both time and participation constraints. It is encouraging that the intervention shows a discernible impact of PACE++ curriculum training on a range of indicators associated with women empowerment and adolescent health and nutrition. The intervention also highlights the feasibility of delivering the modified PACE curriculum in rural settings and the scope for leveraging community platforms such as SHGs for program roll out. This provides further opportunities to scale up these through government initiatives such as SRLM and JEEViKA. The findings overall are encouraging but they also reveal new challenges such as dietary practices among adolescent girls that has huge implications on population health and well-being. Notwithstanding program impact and effect size, greater caution is warranted while scaling up of such models. In particular, appropriate contextualization of the session tools and implementation techniques has an instrumental role to play. Before concluding, it is worth reiterating the adverse effects that adversities such as pandemics can have on adolescent lives. During such testing times the social capital of adolescent group forums and platforms can be of high relevance and support. To conclude, the TARA intervention showcases the importance of delivering the modified PACE++ curriculum in rural settings through leveraging community platforms. The linkages of the program with established government institutions and initiatives boost the sustainability prospects of the initiative. The pilot, therefore, provides robust evidence for upscaling, replicating and promoting similar programs to reach out to all adolescent girls in India and elsewhere. | PMC10624310 |
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Supporting information | (DOC)Click here for additional data file.(ZIP)Click here for additional data file.(DOCX)Click here for additional data file. | PMC10624310 |
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References | PMC10624310 |
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Subject terms | RPE | CORTEX | The benefits of transcranial direct current stimulation (tDCS) on brain function, cognitive response, and motor ability are well described in scientific literature. Nevertheless, the effects of tDCS on athletes’ performance remain unclear. To compare the acute effects of tDCS on the running performance of 5000 m (m) runners. Eighteen athletes were randomized into Anodal (n = 9) groups that received tDCS for 20 min and 2 mA, and Sham (n = 9), in the motor cortex region (M1). Running time in 5000 m, speed, perceived exertion (RPE), internal load and peak torque (Pt) were evaluated. The Shapiro–Wilk test followed by a paired Student’s t-test was used to compare Pt and total time to complete the run between the groups. The running time and speed of the Anodal group (p = 0.02; 95% CI 0.11–2.32; d = 1.24) was lower than the Sham group (p = 0.02, 95% CI 0.05–2.20; d = 1.15). However, no difference was found in Pt (p = 0.70; 95% CI − 0.75 to 1.11; d = 0.18), RPE (p = 0.23; 95% CI − 1.55 to 0.39; d = 0.60) and internal charge (p = 0.73; 95% CI − 0.77 to 1.09; d = 0.17). Our data indicate that tDCS can acutely optimize the time and speed of 5000 m runners. However, no alterations were found for Pt and RPE. | PMC10250526 |
Introduction | RPE | SECONDARY, CORTEX | Transcranial direct current stimulation (tDCS) is a neuromodulation technique that delivers a constant, low-intensity flow of electric current to the scalpStimuli in the motor cortex (M1) region can directly influence sport performanceHowever, some studies failed to identify any acute stimulation effect on M1. In amateur runners they showed no improvement in performance with 15 min of 2 mA stimulationDuring running, the amplitude of individual muscle activation and groupings can vary. Incomplete muscle activation occurs consistently during exhaustive and high-resistance exerciseThe present study’s main objective was to explore an anodic electrode’s effects on the M1 and the performance and RPE in 5000 m runners. The secondary objective was to investigate the effect of tDCS on the knee extensor muscles’ peak torque (Pt) that are fundamental for runners. Therefore, we hypothesized that tDCS at an intensity of 2 mA would improve running times after a 20 min application. | PMC10250526 |
Materials and methods | PMC10250526 |
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Participants | muscle pain | UPPER RESPIRATORY TRACT COMPLICATIONS | Twenty-four runners participating in the running club of the Universidade Federal de Sergipe (UFS) were eligible for the study. The study was designed to be single-blinded, randomized and counter-balanced. Randomization was done using Microsoft Excel 2021 software. Blinding was achieved by telling all participants that they would receive stimulation. We included runners older than 18 years, with a weekly frequency of three to five workouts, at an average pace of 5000 m ≤ 4:30 min/kmWe excluded subjects who (a) did not finish the course due to upper respiratory tract complications, (b) reported muscle pain during warm-up and if they reported fear of electrostimulation (in the case of two runners). The runners were randomized into two groups: Anodal (n = 9; 29 ± 7 years; 63 ± 8 kg) and Sham (n = 9; 25 ± 4 years; 66 ± 12 kg). All runners were blinded. The entire flow chart of the research can be seen in (Fig. Description of sample selection and randomization | PMC10250526 |
Ethical consideration | The entire procedure was explained to the athletes, who signed the informed consent form. The study was approved by the Ethics Committee on Human Beings of UFS (CAAE: 56703722.2.0000.5546), according to the Helsinki declaration, with Brazilian Clinical rials Registry, (03/27/2023), (RBR-4yt3pvc). | PMC10250526 |
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Experimental protocol | The athletes visited the Physical Education Department—athletics track at UFS to perform a familiarization session on the procedure and data collection. Initially, we collected the peak torque in three trials, with 30 s of recovery between them. The tDCS was performed for 20 min at an intensity of 2 mA. After a 10-min warm-up, the runners started a 5000-m race on an official athletic track. At the end of the run, there was a 3-min rest, after which the peak torque was reevaluated. The survey design can be seen in (Fig. Experimental design— | PMC10250526 |
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Transcranial direct current stimulation (tDCS) | The tDCS was applied according to the guidelines proposed by Vitor-Costa et al. | PMC10250526 |
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Peak torque | Peak torque (Pt) was evaluated as the maximum isometric torque generated by the knee extensor muscles. The Pt was determined by multiplying the peak isometric force and the length of the segment, given by the distance between the attachment point of the load cell cable and the center of the knee joint. For this evaluation, a load cell (Kratos model CZC500) fixed on an inextensible cord and attached near the malleolus by means of a Velcro system positioned next to the malleoli was used | PMC10250526 |
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Running test | Vollo® | After the stimulation, the athletes were instructed to start the 5000 m course on the official athletics track at the command of the sound signal. The time to complete the course was recorded using a manual stopwatch (Vollo® VL-512) as well as the average speed of each athlete was observed, through the total time to complete the race. | PMC10250526 |
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Perceived effort and internal load of the training session | The CR-10 | PMC10250526 |
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Statistics | RPE | The normality of the data was assessed by the Shapiro–Wilk test followed by a paired Student’s t-test to compare the Pt and the total time to complete the course between the groups. The RPE and internal charge at each lap were examined by two-way analysis of variance (ANOVA). Tukey’s post-hoc test for multiple comparisons was used whenever necessary. The Cohen d test was used to assess the effect size, adopting the cutoff points of 0.02–0.15 for a small effect, 0.16 to 0.35 as a medium effect, and greater than 0.35 as a large effect. Spearman’s correlation verified the link between RPE and tDCS. We performed a statistical power analysis a priori to estimate the appropriate number of participants required to generate these results. Using G Power program (3.1.9.7), we calculated an effect size (f = 1.5) with 95% confidence (power = 0.95) and α err prob (0.05) in ANOVA repeated measures and between factors. A 95% confidence interval was adopted with a significance value of p < 0.05. The statistical data were tabulated using JAMOVI v. 2.3 software. | PMC10250526 |
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Ethics approval and consent to participate | The study was approved by the Ethics Committee on Human Beings of Universidade Federal de Sergipe (CAAE: 56703722.2.0000.5546), according to the Helsinki declaration.
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Results | PMC10250526 |
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Primary outcomes | No difference was observed between the groups for peak torque (p = 0.70; 95% CI ± 1.11; d = 0.18). Figure Peak torque (Nm) pre and post 5000 m of running and tDCS with 2 mA intensity; ANODAL (n = 9) and SHAM (n = 9). All values are presented as mean ± standard deviation. p = 0.70.Peak torque (Nm) pre and post 5000 m of running and tDCS with 2 mA intensity, the individual values; ANODAL (n = 9) and SHAM (n = 9).The Anodal group showed a decrease in running time (p = 0.02; 95% CI 0.11–2.32; d = 1.24) on the 5000 m course compared to the Sham group. The absolute difference identified was 69 s. Figure Total time of the 5000 m run. ANODAL (n = 9) and SHAM (n = 9). Values are presented as mean ± standard deviation. *p = 0.02.Average speed achieved. ANODAL (n = 9) and SHAM (n = 9). Values are presented as mean ± standard deviation. *p = 0.02. | PMC10250526 |
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Secondary outcomes | There was no difference in RPE between the groups (F [1,11] = 1.60, p = 0.23 95% CI − 1.55 to 0.39; d = 0.60). Similarly, the internal load showed no difference (F [1,14] = 0.12, p = 0.73; 95% CI − 0.77 to 1.09; d = 0.17). Figures Perception of Effort at each 400 m lap. Values are presented as mean ± standard deviation. ANODAL (n = 9) and SHAM (n = 9). p = 0.23.Internal Load. ANODAL (n = 9) and SHAM (n = 9). Values are presented as mean ± standard deviation. p = 0.73. | PMC10250526 |
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Discussion | RPE, fatigue | CORTEX | The objective of the present study was to analyze the effects of tDCS on 5000 m running performance, muscle strength and RPE in runners. The results show that 20 min of stimulation with an intensity of 2 mA on the primary motor cortex promoted improved athletic performance by reducing the running time in the Anodal group, with no changes observed for RPE, internal load, and peak torque.The mechanisms of action related to the modulation of neuronal activity induced by tDCS are not yet fully understoodLong-term effects of tDCS may be associated with changes in protein synthesis and gene expressionIn our research, we found that 20 min of pacing can show improvement in running time. However, the results of similar studies still do not show a literature consensus. Recreational runners were found to have no improvement in fatigue after 15 min of stimulation with 2 mA at M1The use of tDCS on the motor cortex has been related to motor development and fatigue toleranceAnother factor that may be related to the lack of improvement in peak torque in our study was the maximum effort performance during the course. It is known that the ability of muscles to generate force becomes progressively impaired during maximum effort and a gradual recovery occurs at the end of physical effortIt is known that RPE and internal load analysis are subjective. Our expectation was to find a significant improvement in the athletes’ RPE as well, considering that there was an improvement in their running performance. The function responsible for the regulation and control of attention is reached by performing an exercise that causes effort and painWe observed self-consciousness as an important point in deciding the stimulation strategy during exercise; in this sense, RPE in each exercise can help the individual better understand the momentary tension caused by physical exertion helping the individual decide to modulate exercise intensityThere are limitations to our study to be considered. We believe that the evaluation of peak torque could have been performed on days other than the 5000 m run, furthermore it could be evaluated immediately after tDCS. If performed on the same day, we suggest longer recovery intervals to gradually return muscle strength after maximal effort. Sample size per group, the lack of crossover design and lack of a third group could be better recommended. We also believe that an investigation with recreational athletes may still be opportune since they present different sensitivities after stimulation because of the lower excitability threshold than trained runners. Further research should be conducted to investigate the chronic effects of tDCS, thus deepening the knowledge regarding the amplitude of responses in performance in these protocols.Finally, the improvements in physical performance related to the acute protocol investigated here can be of great importance for the day-to-day training of athletes. This result implies practical considerations, mainly due to the possibility of access to stimulation and its cost benefit. | PMC10250526 |
Acknowledgements | This paper and the research behind would not have been possible without the members of the Group of studies and Research of performance, sport, health and Paralympic Sports (GEPEPS). The scientific research group also read the draft manuscript and provided comments prior to the journal review process. We would like to thank the members of the Running Club of UFS. | PMC10250526 |
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Author contributions | L.F.S. and E.V.M.P., Planning, Searching, Data Extraction. D.S.S., M.D.J.A., M.S.S.F., Planning, search, data extraction and partial correction of the document. A.F.Z. and H.R.N. Planning, research, partial correction of the document and quality analysis. B.K., K.W. and F.J.A. Article review and writing contributions. R.F.S. Planning. Article review and writing contributions in the final version of the manuscript. All authors read and approved the final manuscript. All authors consent to the publication of this manuscript. | PMC10250526 |
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Data availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10250526 |
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Competing interests | Leila Fernanda dos Santos, Devisson dos Santos Silva, Micael Deivison de Jesus Alves, Erika Vitoria Moura Pereira, Hortência Reis do Nascimento, Matheus Santos de Sousa Fernandes, Aristela de Freitas Zanona, Beat Knechtle, Katja Weiss, Felipe J. Aidar and Raphael Fabricio de Souza declare that they have no competing interests. | PMC10250526 |
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References | PMC10250526 |
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4. Discussion | depression, traumatic, post-traumatic stress symptoms, anxiety | FIRE | In general, the SFA program trainings were well received with the majority of participants in the peer team training and taking the online trainings reporting high levels of satisfaction and increased interest in the topic. Most notably, there were statistically significant findings related to questions about how prepared the department was to provide support for firefighters experiencing behavioral health issues, how well-trained personnel within the department were to handle behavioral health issues, and how confident firefighters were in the skills and knowledge of their company officers to handle behavioral health issues. These findings indicate success in the training implementation improving the department environment related to behavioral health response.Another noteworthy finding was the challenge the team had in accessing and engaging the EAP programs to implement trainings specific to first responders. Past research has found that EAP programs often have low rates or utilization [Changes in behavioral health outcomes over the 12-month intervention period were in the expected direction with scores in post-traumatic stress symptoms, depression, anxiety, and occupational stress decreasing and scores on resilience, coping self-efficacy, and emotional support improving, although the changes were not statistically significant. It is not surprising that changes were not larger with the short follow-up, given the observation period after program implementation was less than one year, because none of the departments were able to fully have their programs up and running right away. Typically, it took departments the first 6 months of the year to implement SFA within their department. However, the fact that the differences among these outcomes were clearly and consistently observed across domains is promising, particularly given that there is limited evidence for the effectiveness of any early supportive interventions for those who are not exhibiting significant symptoms. Given past research about the iatrogenic results of previously implemented, single-session debriefing programs [As with any study, limitations to the present work exist. For instance, questions about knowledge of content areas covered within the trainings were not assessed in the year prior to implementation. Rather, perceptions of knowledge were all assessed after trainings were completed, which could have resulted in a response bias. However, results complement and mirror the longitudinally assessed domains related to perceived support within the department. There are also limitations introduced by varying participation, due to scheduling conflicts or participant attrition. While the one-year implementation was proposed for logistic and budget reasons, it became clear that the timeline for implementation of a program is significantly longer than one year. Future research should focus on long-term outcomes (e.g., changes in mental health outcomes, increases in knowledge and confidence) not only at one year, but the extended impact beyond initial training. Additionally, regular follow-up support and refresher trainings would likely improve long-term outcomes.There are a number of personal and occupational factors that have been found to impact firefighters’ mental and behavioral health. These factors vary from person to person but may include chronic and acute traumatic experiences, physical demands, shift work, sleep disruption, cumulative stress, organizational stressors, family/home life stress, etc. [Interventions designed to support the mental and behavioral health of firefighters are crucial for maintaining their wellbeing. Practical implications of this work should include efforts to further reduce the stigma associated with mental health support; additional research examining training materials designed to help firefighters recognize signs of stress, burnout, or mental health issues; increased access to mental health services; access to peer support services; coping/resilience training; and leadership support. By implementing these measures and with continued research and development, fire departments can improve the behavioral health of their firefighters and create a more supportive and resilient workforce. | PMC10671183 |
Author Contributions | Conceptualization, S.A.J., N.J., W.S.C.P. and R.G.; methodology, S.A.J., W.S.C.P. and C.K.H.; software, C.K.H.; validation, C.K.H. and W.S.C.P.; formal analysis, N.J., C.M.K. and C.K.H.; investigation, S.A.J., P.W., F.L., N.J. and C.M.K.; resources, S.A.J. and W.S.C.P.; data curation, N.J., C.M.K. and C.K.H.; writing—original draft preparation, S.A.J. and R.G.; writing—review and editing, S.A.J., P.W., F.L., N.J., C.M.K., B.S.H., W.S.C.P. and R.G.; visualization, C.K.H.; supervision, S.A.J. and W.S.C.P.; project administration, S.A.J.; funding acquisition, S.A.J. All authors have read and agreed to the published version of the manuscript. | PMC10671183 |
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Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of NDRI-USA (protocol code 015-649, approved on 24 August 2015). | PMC10671183 |
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Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10671183 |
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Data Availability Statement | Data are available upon request. | PMC10671183 |
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Conflicts of Interest | PTSD | FRANK | The author listed immediately below certifies that they have NO conflict of interest to declare: Frank Leto. The authors whose names are listed immediately below report the following conflicts of interest related to the work under consideration: Sara A. Jahnke, Nattinee Jitnarin, Christopher Kaipust, Brittany S. Hollerbach, Christopher K. Haddock, and W.S. Carlos Poston are employed by the National Development & Research Institutes, Inc. (NDRI-USA, Inc.). Patricia Watson is employed by the National Center for PTSD. Richard Gist is employed by the Kansas City (Missouri) Fire Department. All authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10671183 |
References | Seven Cs of Stress First Aid.Stress First Aid (SFA) Protocol.Overview of Study Design.Perceptions of Department Readiness by Intervention Condition.Social Support from Department by Intervention Condition.Negative Reactions to Behavioral Health Issues by Intervention Condition.Participant Characteristics at Post-Intervention Evaluation.Post-Training Evaluations. | PMC10671183 |
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Background | Telephone triage has been established in many countries as a response to the challenge of non-urgent use of out-of-hours primary care services. However, limited evidence is available regarding the effect of training interventions on clinicians’ telephone consultation skills and patient outcomes. | PMC9807970 |
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Methods | REGRESSION, RESPIRATORY TRACT INFECTIONS | This was a pragmatic randomized controlled educational intervention for telephone triage nurses in 59 Norwegian out-of-hours general practitioners’ (GPs) cooperatives, serving 59% of the Norwegian population. Computer-generated randomization was performed at the level of out-of-hours GP cooperatives, stratified by the population size. Thirty-two out-of-hours GP cooperatives were randomized to intervention. One cooperative did not accept the invitation to participate in the educational programme, leaving 31 cooperatives in the intervention group. The intervention comprised a 90-minute e-learning course and 90-minute group discussion about respiratory tract infections (RTIs), telephone communication skills and local practices.We aimed to assess the effect of the intervention on out-of-hours attendance and describe the distribution of RTIs between out-of-hours GP cooperatives and list-holding GPs.The outcome was the difference in the number of doctor’s consultations per 1000 inhabitants between the intervention and control groups during the winter months before and after the intervention. A negative binomial regression model was used for the statistical analyses. The model was adjusted for the number of nurses who had participated in the e-learning course, the population size and patients’ age groups, with the out-of-hours GP cooperatives defined as clusters. | PMC9807970 |
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Results | sore throat, Laryngitis, pneumonia | REGRESSION, LARYNGITIS, SORE THROAT, PNEUMONIA | The regression showed that the intervention did not change the number of consultations for RTIs between the two groups of out-of-hours GP cooperatives (incidence rate ratio 0.99, 95% confidence interval 0.91–1.07). The winter season’s out-of-hours patient population was younger and had a higher proportion of RTIs than the patient population in the list-holding GP offices. Laryngitis, sore throat, and pneumonia were the most common diagnoses during the out-of-hours primary care service. | PMC9807970 |
Conclusions | The intervention did not influence the out-of-hours attendance. This finding may be due to the intervention’s limited scope and the intention-to-treat design. Changing a population’s out-of-hours attendance is complicated and needs to be targeted at several organizational levels. | PMC9807970 |