Brain stimulation and imaging for children with mild traumatic brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.