Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Early Phase 1CompletedNCT01636661

University of Minnesota13 enrolled

Overview

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: 1. tDCS will not produce a major adverse event, including seizure activity. 2. No change in paretic or nonparetic hand function or cognitive status will occur.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hemiparesis

Interventions

tDCSDEVICE

transcranial direct current stimulation- non-invasive brain stimulation

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report. 2. Hemispheric Stroke or Periventricular Leukomalacia 3. Ages 8-17 years old 4. ≥ 10 degrees of active motion at the metacarpophalangeal joint 5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence 6. No evidence of seizure activity within the last 2 years. 7. 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: 1. Metabolic Disorders 2. Neoplasm 3. Epilepsy 4. Disorders of Cellular Migration and Proliferation 5. Acquired Traumatic Brain Injury 6. Expressive Aphasia 7. Pregnancy 8. Indwelling metal or incompatible medical devices 9. Evidence of skin disease or skin abnormalities 10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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: 1. Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest. 2. Physician Evaluation- Child identified as declining in function from pretest to posttest. 3. Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest. Detailed adverse events are reported in the adverse events module.

Time frame: Baseline, Posttest, Follow-Up Session at One-Week

Secondary Outcomes

Hand Function Decline as Measured by Number of Participants

Measured by the Box and Blocks Test and Grip Strength

Time frame: Baseline, Posttest, Follow-Up Session at One-Week

Data from ClinicalTrials.gov

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