Transcranial Direct-Current Stimulation in Childhood Dystonia

May 20, 2014 updated by: Terence Sanger, University of Southern California

Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aprille Tongol
  • Phone Number: 213-740-1317
  • Email: tongol@usc.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Contact:
          • Andrea Carrillo
        • Principal Investigator:
          • Terence D Sanger, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current
Device: TDCS (Transcranial Direct-current Stimulation)
active TDCS
Other Names:
  • 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 Names:
  • eldith DC-stimulator (neuroconn, Ilmenau, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand muscle overflow
Time Frame: 10 minutes post- transcranial Direct-current Stimulation (TDCS)
surface EMG measure of overflow into muscles during attempted relaxation.
10 minutes post- transcranial Direct-current Stimulation (TDCS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institutes of Health (NIH)
Crowley Carter Foundation
Don and Linda Carter Foundation

Investigators

  • Principal Investigator: Terence Sanger, MD, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 27, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 27, 2011

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDCS2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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