NCT05762796 · State University of New York at Buffalo
Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
(CI-tDCS)
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Buffalo, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations