Actively Recruiting

Phase Not Applicable
Age: 10Years - 15Years
All Genders
Healthy Volunteers
ID05762796

Assessing the Effects of Transcranial Direct Current Stimulation on Brain Connectivity and Recovery in Children Aged 10 to 15 with Mild Traumatic Brain Injury

Led by State University of New York at Buffalo · Updated on 2026-02-03

10

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

S

State University of New York at Buffalo

Lead Sponsor

N

National Center for Advancing Translational Sciences (NCATS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Who Can Participate

Age: 10Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 10 to 15 years at enrollment
  • For experimental group: sustained mild traumatic brain injury or concussion within the past 12 months
  • For experimental group: exhibiting post-concussive symptoms such as difficulty planning or executing motor actions
  • For experimental group: enrolled at least 6 weeks after mTBI injury
  • For healthy controls: no history of concussion
  • Parent and child must be proficient in English
Not Eligible

You will not qualify if you...

  • Loss of consciousness longer than 30 minutes
  • Post-traumatic amnesia longer than 24 hours
  • Intracranial findings on clinical imaging
  • History of developmental delay
  • History of learning disability or ADHD
  • Unhealed lower or upper limb injury
  • History of seizures
  • Severe skin problems at electrode sites
  • Presence of metal implants or shrapnel anywhere in the body
  • Any electronic implants such as pacemaker, cochlear implant, defibrillator, or deep brain stimulator
  • Craniotomy or surgery within past 6 weeks
  • Claustrophobia
  • Eye injury involving metal without clearance
  • Pregnancy for females, with additional post-consent screening for females aged 14 and above

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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)

Observational for Healthy Controls

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)

Trial Site Locations

Total: 1 location

1

Ghazala Saleem

Buffalo, New York, United States, 14214

Actively Recruiting

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Research Team

G

Ghazala Saleem, EdD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation.

Andre Russowsky Brunoni, Joao Amadera, Bruna Berbel...

https://pubmed.ncbi.nlm.nih.gov/21320389

Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel.

F Fregni, M A Nitsche, C K Loo...

https://pubmed.ncbi.nlm.nih.gov/25983531