NCT03618849

tDCS in Pediatric Acquired Brain Injury

Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Acquired Brain Injury (tDCS in Pediatric ABI)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Acquired Brain Injury
• Disorders of Consciousness

Interventions

Type	Name	Description
DEVICE	tDCS	Real and sham tDCS/Mozart piano sonata (K.448)

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2018-08-07
• Last updated: 2024-02-02

Locations

1 site across 1 country: United States