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Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)

This study has been completed.
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01636661
First received: June 11, 2012
Last updated: March 18, 2014
Last verified: March 2014

June 11, 2012
March 18, 2014
July 2012
August 2013   (final data collection date for primary outcome measure)
Safety [ Time Frame: One week ] [ Designated as safety issue: Yes ]
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation and behavioral outcome measures.
Same as current
Complete list of historical versions of study NCT01636661 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Hemiparesis
Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Name: transcranial direct current stimulation
  • Experimental: Transcranial Direct Current Stimulation
    Receiving active tDCS
    Intervention: Device: tDCS
  • Sham Comparator: Sham tDCS
    tDCS equipment set to placebo setting.
    Intervention: Device: tDCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01636661
1205M13901
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Principal Investigator: Bernadette Gillick, PhD, MS, PT University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP