TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

The University of Texas Health Science Center, Houston5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Childhood Stroke

Interventions

Transcranial Direct Current Stimulation (tDCS)DEVICE

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage. * Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke) * 3 months or greater from stroke onset * Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm. * Affected arm Fugl-Meyer score of 60 or lower. * Able to participate in occupational therapy sessions. Exclusion Criteria: * Uncontrolled epilepsy, defined as seizure within the past 6 months. * Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation. * Presence of cranial metal implants or implant device that could be affected by tDCS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants Who Complete the Study

Time frame: 1-week post therapy

Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function

Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. Total score ranges from 0 to 66, with a higher score indicating greater arm function.

Time frame: 1 week post therapy

Secondary Outcomes

Tolerability as Assessed by the Number of Patients That Endorse Any Side Effects as Documented on the Stimulation Monitoring Sheet

Time frame: immediately post stimulation Day 1, immediately post stimulation Day 2, immediately post stimulation Day 3, immediately post stimulation Day 4, immediately post stimulation Day 5

Tolerability as Assessed by the Number of Patients With Hypotension or Hypertension on Blood Pressure Monitoring

Time frame: From baseline to 1 week post-therapy session

Tolerability as Assessed by the Number of Patients With a Decrease in Score of 5 or Greater on the Peg-Board Test

The peg-board test is scored from 0 to 50, with the score indicating the number of pegs placed correctly into the board using the affected hand. A higher score indicates a better outcome, and a decrease in score over time indicates worsening of functioning over time. The number of participants with a decrease in score of 5 or greater on the peg-board test is reported.

Time frame: Baseline, immediately post stimulation Day 5

Arm Function as Assessed by the Fugl-Meyer Score of Upper Extremity Function

Data from ClinicalTrials.gov

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