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/30414398Actively 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
S
State University of New York at Buffalo
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
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
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Complete this quick 3-step screening to check your eligibility
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)
Total: 1 location
1
Ghazala Saleem
Buffalo, New York, United States, 14214
Actively Recruiting
G
Ghazala Saleem, EdD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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