Transcranial Direct-Current Stimulation in Childhood Dystonia

Childhood Onset Dystonias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01460771
• Other study ID #: TDCS2011
• Status: Unknown status
• Phase: Phase 2
• First received: September 27, 2011
• Last updated: May 20, 2014
• Start date: September 2011
• Est. completion date: September 2017

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: Aprille Tongol
• Phone: 213-740-1317
• Email: tongol[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Onset Dystonias
• Dystonia
• Dystonic Disorders

Intervention

Device:
• TDCS (Transcranial Direct-current Stimulation)
active TDCS
• sham TDCS (Transcranial Direct-current Stimulation)
TDCS at 0mA

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Crowley Carter Foundation, Don and Linda Carter Foundation, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand muscle overflow	surface EMG measure of overflow into muscles during attempted relaxation.	10 minutes post- transcranial Direct-current Stimulation (TDCS)