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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemiparesis Device: tDCS Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Study Start Date : July 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcranial Direct Current Stimulation
Receiving active tDCS
 Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Name: transcranial direct current stimulation
Sham Comparator: Sham tDCS
tDCS equipment set to placebo setting.
 Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Name: transcranial direct current stimulation


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636661


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Minnesota Medical Foundation
Investigators
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Principal Investigator: Bernadette Gillick, PhD, MS, PT University of Minnesota
More Information
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Publications of Results:

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01636661    
Other Study ID Numbers: 1205M13901
First Posted: July 10, 2012    Key Record Dates
Results First Posted: July 20, 2015
Last Update Posted: November 9, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Paresis
Neurologic Manifestations
Nervous System Diseases