Transcranial Direct-Current Stimulation in Childhood Dystonia
Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 27, 2011
CompletedFirst Posted
Study publicly available on registry
October 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedMay 22, 2014
May 1, 2014
6 years
September 27, 2011
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hand muscle overflow
surface EMG measure of overflow into muscles during attempted relaxation.
10 minutes post- transcranial Direct-current Stimulation (TDCS)
Study Arms (2)
Treatment
EXPERIMENTALActive Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current
sham
SHAM COMPARATORinactive Transcranial Direct current stimulation (TDCS) at 0mA
Interventions
active TDCS
TDCS at 0mA
Eligibility Criteria
You may qualify if:
- dystonia affecting one or both hands
- age 4 to 21 years
You may not qualify if:
- metal implants in the head
- inability to cooperate with instructions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Institutes of Health (NIH)collaborator
- Crowley Carter Foundationcollaborator
- Don and Linda Carter Foundationcollaborator
Study Sites (1)
University of Southern California
Los Angeles, California, 90089, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terence Sanger, MD, PhD
University of Southern California
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 27, 2011
First Posted
October 27, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
May 22, 2014
Record last verified: 2014-05