Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Hemiparesis
In brief
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.
Key facts
- Study ID
- NCT01636661
- Run by
- University of Minnesota
- People needed
- 13
- Starts
- 2012-07-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2015-11-09
Who can join
Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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