Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:8 - 17
Updated:4/21/2016
Start Date:July 2012
End Date:December 2013

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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:

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.

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
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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