Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury (CI-tDCS)
Brain Concussion, Mild Traumatic Brain Injury, Motor Disorders
About this trial
This is an interventional treatment trial for Brain Concussion focused on measuring Brain Concussion, Mild Traumatic Brain Injury, Child, Motor Activity, Cognitive Impairment, Transcranial Direct Current Stimulation, Neuroimaging
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.
Sites / Locations
- Ghazala SaleemRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Healthy Controls
tDCS in Youth with mild traumatic brain injury
Never-concussed age-and gender-matched healthy controls will not receive any intervention. Behavioral and neuroimaging measurements will be administered only once, at the initial visit.
Behavioral as well as neuroimaging measurements will be administered at the final post-anodal transcranial direct current stimulation (tDCS), final post-sham tDCS, and at 30-day follow-up visits. tDCS will be administered after the initial behavioral and neuroimaging testing. Ten sessions of 1.5 mA real tDCS and 10 sessions of sham tDCS will be administered using Neurocom (Germany) DC stimulator and two 5x7 electrodes, moistened in saline solution, to 10 participants with mTBI following a cross-over design with a 2-week washout period. The location of the brain regions will be determined using either the Transcranial Magnetic Stimulation Neuronavigation or Brainsight Neuronavigation system. The anode will be placed over pre-determined brain regions, whereas the cathode will be placed either over Fp2 (contralateral supraorbital) or other suitable reference areas.