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Transcranial Direct-Current Stimulation in Childhood Dystonia

This study is currently recruiting participants.
Verified January 2013 by University of Southern California
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Crowley-Carter Foundation
Don and Linda Carter Foundation
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
ClinicalTrials.gov Identifier:
NCT01460771
First received: September 27, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

The investigators hypothesize that transcranial direct current stimulation over the motor cortex will reduce muscle overflow and improve hand function in children with primary or secondary dystonia.


Condition Intervention Phase
Childhood Onset Dystonias
 Device: TDCS (Transcranial Direct-current Stimulation)
Device: sham TDCS (Transcranial Direct-current Stimulation)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia

Resource links provided by NLM:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Hand muscle overflow [ Time Frame: 10 minutes post- transcranial Direct-current Stimulation (TDCS) ] [ Designated as safety issue: No ]
    surface EMG measure of overflow into muscles during attempted relaxation.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current
 Device: TDCS (Transcranial Direct-current Stimulation)
active TDCS
Other Name: eldith DC-stimulator (neuroconn, Ilmenau, Germany)
Sham Comparator: sham
inactive Transcranial Direct current stimulation (TDCS) at 0mA
 Device: sham TDCS (Transcranial Direct-current Stimulation)
TDCS at 0mA
Other Name: eldith DC-stimulator (neuroconn, Ilmenau, Germany)

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dystonia affecting one or both hands
  • age 4 to 21 years

Exclusion Criteria:

  • metal implants in the head
  • inability to cooperate with instructions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460771

Contacts
Contact: Aprille Tongol 213-740-1317 tongol@usc.edu
Contact: Diana Ferman 310-425-2342 dferman@usc.edu

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Andrea Carrillo            
Principal Investigator: Terence D Sanger, MD, PhD            
Sponsors and Collaborators
University of Southern California
National Institutes of Health (NIH)
Crowley-Carter Foundation
Don and Linda Carter Foundation
Investigators
Principal Investigator: Terence Sanger, MD, PhD University of Southern California
  More Information

No publications provided

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01460771     History of Changes
Other Study ID Numbers: TDCS2011
Study First Received: September 27, 2011
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
childhood dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013