Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
State University of New York at Buffalo · with National Center for Advancing Translational Sciences (NCATS) · NCT05762796
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 10–15 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 10
- US sites recruiting
- 1
- Study start
- February 20, 2024
- Record last updated
- February 3, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: tDCS in Youth with mild traumatic brain injury
Conditions: Brain Concussion; Mild Traumatic Brain Injury; Motor Disorders; Cognitive Impairment
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Ghazala Saleem
Buffalo, NY 14214
Site contact: Ghazala Saleem, EdD · 7168292589 · GHAZALAS@BUFFALO.EDU
Study contacts (from the official record)
- Ghazala Saleem, EdD · 716-829-2589 · GHAZALAS@BUFFALO.EDU
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