Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis (tDCS)
This study is currently recruiting participants.
Verified February 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
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: February 5, 2013
Last verified: February 2013
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Purpose
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:
- tDCS will not produce a major adverse event, including seizure activity.
- No change in paretic or nonparetic hand function or cognitive status will occur.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemiparesis |
Device: tDCS |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis |
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 8 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 metacarpalphalangeal 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636661
Contacts
| Contact: Maureen Boxrud, BA | 612-626-6415 | brown029@umn.edu |
| Contact: Bernadette Gillick, PhD | 612-626-3121 | gillick@umn.edu |
Locations
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: Bernadette Gillick, PhD, MS, PT | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Investigators
| Principal Investigator: | Bernadette Gillick, PhD, MS, PT | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01636661 History of Changes |
| Other Study ID Numbers: | 1205M13901 |
| Study First Received: | June 11, 2012 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Paresis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013