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Transcranial Direct-Current Stimulation in Childhood Dystonia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Terence Sanger, University of Southern California.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460771
First Posted: October 27, 2011
Last Update Posted: May 22, 2014
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.
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
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Terence Sanger, University of Southern California:

Primary Outcome Measures:
  • Hand muscle overflow [ Time Frame: 10 minutes post- transcranial Direct-current Stimulation (TDCS) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01460771     History of Changes
Other Study ID Numbers: TDCS2011
First Submitted: September 27, 2011
First Posted: October 27, 2011
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Terence Sanger, 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


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