TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

Study Overview
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Brief Summary
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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

Official Title
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TOlerability of Transcranial Direct Current Stimulation in Pediatric Stroke Survivors

Conditions
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Childhood Stroke

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Direct Current Stimulation (tDCS)<br> | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients who complete the study |  | 1-week post therapy | 
| Improvement of arm function as assessed by the Fugl-Meyer score of Upper extremity function (increase of 5 points or more) | 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. The total possible scale score is 66 | 1 week post therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tolerability as assessed by the percent of patients that endorse mild side effects as documented on the stimulation monitoring sheet |  | pre and immediately post stimulation Day1,pre and immediately post stimulation Day 2, pre and immediately post stimulation Day 3,pre and immediately post stimulation Day 4, pre and immediately post stimulation Day 5 | 
| Change in tolerability as assessed by the percent of patients with hypotension or hypertension on blood pressure monitoring |  | pre and immediately post stimulation Day1,pre and immediately post stimulation Day 2, pre and immediately post stimulation Day 3,pre and immediately post stimulation Day 4, pre and immediately post stimulation Day 5, 1 week post-therapy session | 
| Change in tolerability as assessed by the percent of patients with worsening of the Peg-board test (decreased score by 5 or greater) on the Peg-Board Test | Peg-board is scored from 0 to 50, as the number of pegs placed correctly into the board using the affected hand a higher number indicating better outcome | Baseline,immediately post stimulation Day1, immediately post stimulation Day 2, immediately post stimulation Day 3,immediately post stimulation Day 4, immediately post stimulation Day 5 | 
| Improvement of arm function as assessed by the Fugl-Meyer score of Upper extremity function (increase of 5 points or more) | 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. The total possible scale score is 66 | 3 month post therapy assessment | 
| Change in quality of unilateral upper limb movement as assessed by the Melbourne Assessment of the Upper Extremity (MUUL) | This assessment has a total score range of 0-100% a higher score indicating better outcome | Baseline,1 week post therapy , 3 month post therapy assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromodulation, transcranial direct current stimulation, stroke, rehabilitation, childhood stroke