NCT05812794

TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 5 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability of tDCS in childhood stroke survivors and to assess for improvement in arm function in patients receiving tDCS and occupational therapy

Conditions

• Childhood Stroke

Interventions

Type	Name	Description
DEVICE	Transcranial Direct Current Stimulation (tDCS)	Participants will come for 5 sequential days of 2 hour long occupational therapy sessions augmented by tDCS for the first 20 minutes of the session. At arrival, the "stimulation safety sheet" will be completed by the occupational therapist.The saline soaked electrodes will be placed on the study subjects head and connected to the Soterix 1x1 Limited Total Energy (LTE) enabled tDCS device. Current output through the device will be sham stimulation on day 1 , followed by steady increases to a maximum of 1milliampere (mA) in patients aged 5-12 years old, and 1.5 mA in patients aged 13-19 years old, per the study design flow sheet at the end of this protocol. Blood pressure, pulse rate, and peg-board scores will be recorded as indicated on the stimulation safety sheet during each session.A repeat assessment will be done by the occupational therapist one week post therapy completion.There will be a repeat assessment visit 3 months post intervention.

Timeline

• Start date: 2023-06-30
• Primary completion: 2023-12-11
• Completion: 2024-03-15
• First posted: 2023-04-14
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study