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Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

RecruitingHealthy volunteers welcome

Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury

Who can join

Ages 10 to 15 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Experimental Cohort:

Inclusion Criteria:

* age 10-15 years at enrollment
* enrolled after 6 weeks of mTBI injury
* exhibiting post-concussive symptoms (e.g., difficulty planning, sequencing, and executing a motor action)
* Sustained an mTBI or concussion within the past 12 months
* Parent and child proficient in English

Healthy Controls Cohort:

Inclusion Criteria:

* 10 to 15 years old
* no concussion history
* Parent and child proficient in English

Experimental Cohort:

Exclusion Criteria:

* loss of consciousness \> 30 minutes
* post-traumatic amnesia \> 24 hours
* intracranial findings on clinical imaging
* history of developmental delay
* history of learning disability or ADHD
* Sustained a lower limb or upper limb injury that has not healed
* History of Seizures
* Noticeable skin lesions/burns or any other severe skin problems at the site of the electrodes before the start of the stimulation.
* Parent/guardian report metal implants anywhere in the head/ncek/body on the MRI screening form (see attached).
* Parent/guardian report shrapnel/bullets in the body on the MRI screening form.
* Parent/guardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.
* Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.
* Parent/guardian report being claustrophobic on the MRI screening form.
* Parent/guardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.
* Pregnant females as reported by parent/guardian on the pre-consent screening form. Pubertal/post-pubertal female participants14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.

Healthy Controls Cohort:

Exclusion Criteria:

* diagnosed with developmental delay
* sustained a lower limb or upper limb injury that has not healed
* history of Learning Disability and/or ADHD
* Parent/guardian report metal implants anywhere in the head/ncek/body on the MRI screening form (see attached).
* Parent/guardian report shrapnel/bullets in the body on the MRI screening form.
* Parent/guardian report any electronic implant such as a cardiac pacemaker, cochlear implant, ventricular shunt, cardiac defibrillator, aneurysm clips, pacing wires, any implant held in place with a magnet, heart valve, or deep brain stimulator on the MRI screening form.
* Parent/guardian report a craniotomy or any other surgery in the past 6 weeks on the MRI screening form.
* Parent/guardian report being claustrophobic on the MRI screening form.
* Parent/guardian report and provide orbit x-ray after the eye injury involving a metal that the subject is cleared as indicated on the MRI screening form.
* Pregnant females as reported by parent/guardian on the pre-consent screening form. Post-pubertal females 14 and above will be provided a separate post-consent screening form at each MRI visit to ensure the female reports accurately without fear.

About the study

Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.

What is being tested

Sponsor: State University of New York at Buffalo · Participants: 10 · Started: Feb 20, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05762796

Locations in the U.S.

New YorkGhazala Saleem, Buffalo

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.