CompletedEarly Phase 1

Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

United States13 participantsStarted 2012-07

Plain-language summary

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.

Who can participate

Age range8 Years – 17 Years

SexALL

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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

What they're measuring

Adverse Events/Safety Assessment.

Timeframe: Baseline, Posttest, Follow-Up Session at One-Week

Trial details

NCT IDNCT01636661

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2015-06-22

View on ClinicalTrials.gov More Hemiparesis trials