Neuromodulation and Neuroimaging in Older Children With Mild Traumatic Brain Injury

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT05762796
Status
Recruiting
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Conditions

  • Brain Concussion
  • Cognitive Impairment
  • Mild Traumatic Brain Injury
  • Motor Disorders

Eligibility Criteria

Sex
ALL
Age
10 Years - 15 Years
Healthy Volunteers
Accepted

Interventions

  • tDCS in Youth with mild traumatic brain injury — DEVICE
    The safety and tolerability of tDCS have been established in children with mTBI (1). A recent study of 13-18 year youths post-mTBI showed that three sessions of 1.5 mA anodal tDCS over the left DLPFC, positively influenced prolonged working memory deficits. (2) Additionally, rodent studies show the effectiveness of tDCS in improving cognitive-motor (motor planning and balance/gait) function in rats with mTBI. (3)

Study Details

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.

Key Dates

Start date
Feb 20, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Changes in the Revised Physical and Neurological Examination of Subtle Signs (PANESS - Gaits and Stations Measures) [ Time Frame: Day 1 (at the initial visit), Day 26- 30 (final post-anodal transcranial direct current stimulation (tDCS), Day 60 -64 (final post-sham tDCS), and Day 94 (at 30-days follow up visit). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ghazala SaleemBuffaloNew York14214
Ghazala Saleem, EdD
[email protected]
7168292589
[email protected]
Ghazala Saleem, EdD (PRINCIPAL_INVESTIGATOR)

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Ghazala Saleem· Buffalo, NY

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