NCT05762796 · RECRUITING
Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
This trial is testing transcranial direct current stimulation (tDCS) — a mild, non-invasive electrical brain stimulation device — in children ages 10 to 15 who have lingering symptoms after a concussion. Researchers want to see whether it can help restore normal brain communication and improve motor and cognitive function. This is a Phase NA (feasibility or pilot-level) study, meaning it is exploratory and not yet proven effective.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-03