Transcranial Direct-Current Stimulation in Childhood Dyst... | NCT01460771

Studies
Transcranial Direct-Current Stimulation in Childhood Dystonia

NCT01460771

Sponsor

University of Southern California

Status

Unknown status

Last Update Posted

May 22, 2014Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Childhood Onset Dystonias

Interventions

TDCS (Transcranial Direct-current Stimulation)
sham TDCS (Transcranial Direct-current Stimulation)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Sep 27, 2011

First Submission Date that Met QC Criteria

Oct 26, 2011

First Posted Date

Oct 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2014

Last Update Posted Date

May 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Terence Sanger, Associate Professor, University of Southern CaliforniaPrincipal Investigator

Lead Sponsor

University of Southern CaliforniaOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current	Device: TDCS (Transcranial Direct-current Stimulation)
sham	Sham Comparator	inactive Transcranial Direct current stimulation (TDCS) at 0mA	Device: sham TDCS (Transcranial Direct-current Stimulation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TDCS (Transcranial Direct-current Stimulation)	Device	active TDCS	Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aprille Tongol	Contact	213-740-1317		tongol@usc.edu
Diana Ferman	Contact	310-425-2342		dferman@usc.edu

Overall Officials

Name	Affiliation	Role
Terence Sanger, MD, PhD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California	Recruiting	Los Angeles	California	90089	United States

Type	Date	Date Unknown
Release	May 28, 2015
Reset	Jun 11, 2015
Release	Mar 31, 2017
Reset	May 10, 2017
Release	Apr 3, 2024
Reset	Apr 30, 2024

Submission Tracking

Estimated Results First Submitted Date

May 28, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 28, 2015			Jun 11, 2015
Mar 31, 2017

Condition Browse Module

MeSH Terms

ID	Term
D020821	Dystonic Disorders

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided