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TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

NCT05812794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-09-26

Study results available
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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

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Stuart M Fraser, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-12-11
Completion
2024-03-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05812794 on ClinicalTrials.gov