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Transcranial Direct-Current Stimulation in Childhood Dystonia

Primary Purpose

Childhood Onset Dystonias

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TDCS (Transcranial Direct-current Stimulation)
sham TDCS (Transcranial Direct-current Stimulation)
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Onset Dystonias focused on measuring childhood dystonia

Eligibility Criteria

4 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

sham

Arm Description

Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current

inactive Transcranial Direct current stimulation (TDCS) at 0mA

Outcomes

Primary Outcome Measures

Hand muscle overflow
surface EMG measure of overflow into muscles during attempted relaxation.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2011
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH), Crowley Carter Foundation, Don and Linda Carter Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01460771
Brief Title
Transcranial Direct-Current Stimulation in Childhood Dystonia
Official Title
Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institutes of Health (NIH), Crowley Carter Foundation, Don and Linda Carter Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Onset Dystonias
Keywords
childhood dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
inactive Transcranial Direct current stimulation (TDCS) at 0mA
Intervention Type
Device
Intervention Name(s)
TDCS (Transcranial Direct-current Stimulation)
Other Intervention Name(s)
eldith DC-stimulator (neuroconn, Ilmenau, Germany)
Intervention Description
active TDCS
Intervention Type
Device
Intervention Name(s)
sham TDCS (Transcranial Direct-current Stimulation)
Other Intervention Name(s)
eldith DC-stimulator (neuroconn, Ilmenau, Germany)
Intervention Description
TDCS at 0mA
Primary Outcome Measure Information:
Title
Hand muscle overflow
Description
surface EMG measure of overflow into muscles during attempted relaxation.
Time Frame
10 minutes post- transcranial Direct-current Stimulation (TDCS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aprille Tongol
Phone
213-740-1317
Email
tongol@usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Ferman
Phone
310-425-2342
Email
dferman@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence Sanger, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Carrillo
First Name & Middle Initial & Last Name & Degree
Terence D Sanger, MD, PhD

12. IPD Sharing Statement

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Transcranial Direct-Current Stimulation in Childhood Dystonia

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