NCT05762796 Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury
| NCT ID | NCT05762796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State University of New York at Buffalo |
| Condition | Brain Concussion |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-02-20 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Ghazala Saleem, EdD
PRINCIPAL INVESTIGATOR
State University of New York at Buffalo
Frequently Asked Questions
Who can join the NCT05762796 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 15 Years, studying Brain Concussion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05762796 currently recruiting?
Yes, NCT05762796 is actively recruiting participants. Contact the research team at GHAZALAS@BUFFALO.EDU for enrollment information.
Where is the NCT05762796 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT05762796 clinical trial?
NCT05762796 is sponsored by State University of New York at Buffalo. The principal investigator is Ghazala Saleem, EdD at State University of New York at Buffalo. The trial plans to enroll 10 participants.