Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 15
Healthy Volunteers: t
View:
• 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:
• 10 to 15 years old
• no concussion history
• Parent and child proficient in English
⁃ Experimental Cohort:
Locations
United States
New York
Ghazala Saleem
RECRUITING
Buffalo
Contact Information
Primary
Ghazala Saleem, EdD
GHAZALAS@BUFFALO.EDU
716-829-2589
Time Frame
Start Date: 2024-02-20
Estimated Completion Date: 2026-06
Participants
Target number of participants: 10
Treatments
No_intervention: Healthy Controls
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.
Experimental: tDCS in Youth with mild traumatic brain injury
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.
Related Therapeutic Areas
Sponsors
Leads: State University of New York at Buffalo
Collaborators: National Center for Advancing Translational Sciences (NCATS)