Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Study Overview
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Brief Summary
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The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis. The research question, Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis? relates to two hypotheses: tDCS will not produce a major adverse event, including seizure activity. No change in paretic or nonparetic hand function or cognitive status will occur.

Detailed Description
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Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.

Official Title
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Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Conditions
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Hemiparesis

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report. Hemispheric Stroke or Periventricular Leukomalacia Ages 8-17 years old ≥ 10 degrees of active motion at the metacarpophalangeal joint Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence No evidence of seizure activity within the last 2 years. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature. Exclusion Criteria: Metabolic Disorders Neoplasm Epilepsy Disorders of Cellular Migration and Proliferation Acquired Traumatic Brain Injury Expressive Aphasia Pregnancy Indwelling metal or incompatible medical devices Evidence of skin disease or skin abnormalities Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Direct Current Stimulation<br>Receiving active tDCS | Device: tDCS<br>* transcranial direct current stimulation- non-invasive brain stimulation<br>* Other names: transcranial direct current stimulation;|
| Sham Comparator: Sham tDCS<br>tDCS equipment set to placebo setting. | Device: tDCS<br>* transcranial direct current stimulation- non-invasive brain stimulation<br>* Other names: transcranial direct current stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events/Safety Assessment. | Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria: Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. Physician Evaluation- Child identified as declining in function from pretest to posttest. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module. | Baseline, Posttest, Follow-Up Session at One-Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand Function Decline as Measured by Number of Participants | Measured by the Box and Blocks Test and Grip Strength | Baseline, Posttest, Follow-Up Session at One-Week |