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History of Changes for Study: NCT01636661
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)
Latest version (submitted October 7, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 5, 2012 None (earliest Version on record)
2 July 13, 2012 Recruitment Status, Study Status and Contacts/Locations
3 February 5, 2013 Sponsor/Collaborators and Study Status
4 March 18, 2014 Recruitment Status, Study Status, Contacts/Locations, Study Design and Eligibility
5 February 6, 2015 Study Status
6 June 22, 2015 Study Status, Results and References
7 August 7, 2015 Adverse Events and Study Status
8 October 7, 2015 Outcome Measures, Adverse Events, Study Status and Study Design
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Study NCT01636661
Submitted Date:  July 5, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 1205M13901
Brief Title: Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)
Official Title: Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2012
Overall Status: Not yet recruiting
Study Start: July 2012
Primary Completion: February 2014 [Anticipated]
Study Completion: February 2014 [Anticipated]
First Submitted: June 11, 2012
First Submitted that
Met QC Criteria:
July 5, 2012
First Posted: July 10, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 5, 2012
Last Update Posted: July 10, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Minnesota
Responsible Party: Principal Investigator
Investigator: Bernadette Gillick
Official Title: Assistant Professor
Affiliation: University of Minnesota
Collaborators: Minnesota Medical Foundation
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Hemiparesis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Early Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Transcranial Direct Current Stimulation
Receiving active tDCS
Device: tDCS
transcranial direct current stimulation- non-invasive brain stimulation
Other Names:
  • 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 Names:
  • transcranial direct current stimulation
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 8 Years
Maximum Age: 17 Years
Sex: All
Gender Based:
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 metacarpalphalangeal 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
Open or close this module Contacts/Locations
Central Contact Person: Maureen Boxrud, BA
Telephone: 612-626-6415
Email: brown029@umn.edu
Central Contact Backup: Bernadette Gillick, PhD
Telephone: 612-626-3121
Email: gillick@umn.edu
Study Officials: Bernadette Gillick, PhD, MS, PT
Principal Investigator
University of Minnesota
Locations: United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Contact:Principal Investigator: Bernadette Gillick, PhD, MS, PT
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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