Transcranial Direct Current Stimulation in Pediatric Motor Disorders: A Systematic Review and Meta-analysis.
Ghazala T Saleem, Jewel E Crasta, Beth S Slomine...
https://pubmed.ncbi.nlm.nih.gov/30414398/Actively Recruiting
Led by State University of New York at Buffalo · Updated on 2026-02-03
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
Researchers are investigating the effects of mild traumatic brain injury mTBI in children aged 10 to 15 years, focusing on persistent motor and cognitive difficulties that affect daily functioning. The study aims to test a brain stimulation method called transcranial direct current stimulation tDCS alongside evaluating objective tools that record and restore communication between affected brain areas to support recovery in youth after mTBI. This research addresses the lack of objective biomarkers and standard treatments for childhood mTBI, which can disrupt neurodevelopment and lead to chronic neurological problems. The study involves two groups 10 youths with mTBI who will receive both real and sham tDCS treatments in a cross-over design, and 10 healthy age- and gender-matched controls who will not receive any intervention. The tDCS treatment consists of ten sessions of 1.5 mA stimulation applied using specialized devices with electrodes placed on targeted brain regions, followed by a two-week washout period before switching treatments. Behavioral and neuroimaging tests will be conducted before and after each treatment phase, as well as at a 30-day follow-up. Participants will undergo various assessments, including motor control tests, cognitive and neurological exams, and functional MRI scans to monitor changes in brain connectivity and function. Measurements will be taken at multiple time points initial visit, after anodal and sham tDCS treatments, and during follow-up visits. The study will also track mood and anxiety levels and cognitive abilities using standardized questionnaires. Overall participation lasts about 94 days, allowing researchers to evaluate the impact of tDCS on recovery and brain function over time.
CONDITIONS
Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
G
Ghazala Saleem, EdD
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State University of New York at Buffalo
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | tDCS in Youth with mTBI | Healthy Controls (No Intervention) |
|---|---|---|
| What it is | Non-invasive brain stimulation using transcranial direct current stimulation (tDCS) for children aged 10–15 years with a mild traumatic brain injury who continue to have motor or cognitive symptoms. | No intervention; healthy children aged 10–15 years without a history of concussion serve as an observational comparison group. |
| Role in trial | Assesses whether tDCS can improve persistent motor and cognitive symptoms following mild traumatic brain injury. | Provides a baseline for neurological and motor function in healthy children, offering a comparison for evaluating changes in the tDCS-treated group. |
| Primary use or purpose | Potential therapeutic approach for persistent post-concussive symptoms in children and youth after mild traumatic brain injury. | Serves as a normative reference group to compare against youth with mTBI receiving tDCS. |
| How it is given or performed | Participants receive several sessions of anodal tDCS over the left dorsolateral prefrontal cortex, with safety and tolerability monitored throughout. | No device or stimulation; healthy controls undergo the same assessments and neuroimaging as the intervention group. |
| Evidence status | Evidence for tDCS in pediatric motor disorders is limited but suggests possible cognitive-motor benefits; more robust trials in children with mTBI are needed to establish effectiveness. | The standard for healthy children with no history of concussion is observation only; there is no intervention as this group represents typical neurological development. |
| Important limitations | tDCS remains investigational in children, and long-term benefits and risks, as well as the optimal dosing, are not well established. Studies to date have small sample sizes and limited follow-up. | The healthy control group provides observational data but does not reflect typical clinical management needs following mTBI. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks including washout
Participants with mild traumatic brain injury receive 10 sessions of real transcranial direct current stimulation (tDCS) and 10 sessions of sham tDCS in a cross-over design with a 2-week washout period. Behavioral and neuroimaging assessments are conducted before and after each treatment phase.
Multiple visits including initial baseline testing, post-anodal tDCS, and post-sham tDCS visits
Duration - 30 days after treatment completion
Participants complete a follow-up visit 30 days after the final treatment to assess recovery and changes in cognitive-motor function and brain connectivity.
1 follow-up visit (in-person)
Duration - Single visit
Never-concussed healthy control participants complete behavioral and neuroimaging measurements once at the initial visit without receiving any intervention.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/21320389/State University of New York at Buffalo
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor