Brain stimulation and imaging for children with mild traumatic brain injury
Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury
This study is testing if a type of brain stimulation can help children aged 10-15 recover better from mild traumatic brain injuries by improving their thinking and movement skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 10 Years to 15 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05762796 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcranial direct current stimulation (tDCS) on children aged 10-15 who have experienced mild traumatic brain injury (mTBI). It aims to evaluate how this non-invasive treatment can improve cognitive and motor functions by modulating brain activity. The study also seeks to establish objective biomarkers for predicting recovery and guiding treatment in pediatric mTBI cases. By combining brain stimulation with neuroimaging techniques, the research hopes to enhance understanding of the neurophysiological impacts of mTBI in children.
Who should consider this trial
Good fit: Ideal candidates include children aged 10-15 who have sustained an mTBI within the past 12 months and are experiencing post-concussive symptoms.
Not a fit: Patients who have a history of severe concussions, developmental delays, or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery outcomes and better management of cognitive and motor deficits in children following mTBI.
How similar studies have performed: While the efficacy of tDCS in children with mTBI is not yet established, similar approaches in adults have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Buffalo, New York
- Ghazala Saleem — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ghazala Saleem, EdD — State University of New York at Buffalo
- Study coordinator: Ghazala Saleem, EdD
- Email: GHAZALAS@BUFFALO.EDU
- Phone: 716-829-2589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.