Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Launched by STATE UNIVERSITY OF NEW YORK AT BUFFALO · Feb 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for children aged 10 to 15 who have experienced a mild traumatic brain injury (mTBI), commonly known as a concussion. The researchers want to test a method that uses brain stimulation to help improve communication between areas of the brain affected by the injury. This could potentially help children recover from ongoing challenges like difficulty with movement and thinking clearly after their concussion.

To participate in the study, children must be between 10 and 15 years old and have had a concussion within the past year, showing symptoms like trouble planning or executing actions. Families should also be comfortable speaking English. On the other hand, healthy children with no concussion history can also join as control participants. Throughout the trial, participants will undergo brain stimulation and various assessments to track their progress. It’s important for families to know that there are specific health criteria that may exclude some children from participating, such as a history of severe brain injuries or certain medical conditions.

Gender

ALL

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.