Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01636661
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : July 20, 2015
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE June 11, 2012
First Posted Date  ICMJE July 10, 2012
Results First Submitted Date  ICMJE June 22, 2015
Results First Posted Date  ICMJE July 20, 2015
Last Update Posted Date November 9, 2015
Study Start Date  ICMJE July 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Adverse Events/Safety Assessment. [ Time Frame: Baseline, Posttest, Follow-Up Session at One-Week ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
Safety [ Time Frame: One week ]
Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation and behavioral outcome measures.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
Hand Function Decline as Measured by Number of Participants [ Time Frame: Baseline, Posttest, Follow-Up Session at One-Week ]
Measured by the Box and Blocks Test and Grip Strength
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Official Title  ICMJE Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Brief 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemiparesis
Intervention  ICMJE Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Name: transcranial direct current stimulation
Study Arms  ICMJE
  • Experimental: Transcranial Direct Current Stimulation
    Receiving active tDCS
    Intervention: Device: tDCS
  • Sham Comparator: Sham tDCS
    tDCS equipment set to placebo setting.
    Intervention: Device: tDCS
Publications * Gillick BT, Feyma T, Menk J, Usset M, Vaith A, Wood TJ, Worthington R, Krach LE. Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study. Phys Ther. 2015 Mar;95(3):337-49. doi: 10.2522/ptj.20130565. Epub 2014 Nov 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2014)
13
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2012)
20
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01636661
Other Study ID Numbers  ICMJE 1205M13901
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Minnesota
Original Responsible Party Bernadette Gillick, University of Minnesota, Assistant Professor
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Minnesota Medical Foundation
Investigators  ICMJE
Principal Investigator: Bernadette Gillick, PhD, MS, PT University of Minnesota
PRS Account University of Minnesota
Verification Date October 2015

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