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Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Acquired Brain Injury (tDCS in Pediatric ABI)
In this preliminary study, we will examine the safety, tolerability, and feasibility of transcranial direct current stimulation (tDCS), in the setting of dosage escalation, as a candidate intervention for children with Acquired Brain Injury (ABI).
Previous studies have demonstrated that transcranial direct current stimulation (tDCS) is safe and effective in adults with chronic Acquired Brain Injury. Limited data have established the safety of tDCS in children with neuropsychiatric and neuromotor disorders. However, these tDCS safety paradigms may not be relevant to children with ABI due to their abnormal brain structure and function, decreased ability to communicate, variable symptomology, and time-consuming care needs that exist in this population. In this open-label, single-group, dosage escalation study, investigators aim to assess the safety, tolerability, and feasibility of incrementally higher tDCS currents in 10 pediatric patients with ABI on an inpatient rehabilitation unit. The study will include up to three sessions of tDCS (sham, 1mA, and then 2 mA) either over the left dorsolateral prefrontal cortex or over the primary motor cortex based on the goal to evaluate change in either cognitive or motor function. We will also explore whether tDCS improves consciousness in pediatric DOC. Mozart classical music, as a concurrent intervention, will be played during sham, 1 mA, and 2 mA tDCS applications.
Age
5 - 17 years
Sex
ALL
Healthy Volunteers
No
Kennedy Krieger Institute
Baltimore, Maryland, United States
Start Date
August 1, 2019
Primary Completion Date
January 31, 2024
Completion Date
January 31, 2024
Last Updated
February 2, 2024
1
ACTUAL participants
tDCS
DEVICE
Lead Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
NCT07378592
NCT06774287
NCT06323031
Data Source & Attribution
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