Transcranial Direct-Current Stimulation in Childhood Dystonia

NCT ID: NCT01460771

Last Updated: 2014-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Childhood Onset Dystonias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

TDCS (Transcranial Direct-current Stimulation)

Intervention Type DEVICE

active TDCS

sham

inactive Transcranial Direct current stimulation (TDCS) at 0mA

Group Type SHAM_COMPARATOR

sham TDCS (Transcranial Direct-current Stimulation)

Intervention Type DEVICE

TDCS at 0mA

Interventions

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TDCS (Transcranial Direct-current Stimulation)

active TDCS

Intervention Type DEVICE

sham TDCS (Transcranial Direct-current Stimulation)

TDCS at 0mA

Intervention Type DEVICE

Other Intervention Names

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eldith DC-stimulator (neuroconn, Ilmenau, Germany) eldith DC-stimulator (neuroconn, Ilmenau, Germany)

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Crowley Carter Foundation

OTHER

Sponsor Role collaborator

Don and Linda Carter Foundation

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Terence Sanger

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terence Sanger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aprille Tongol

Role: CONTACT

213-740-1317

Diana Ferman

Role: CONTACT

310-425-2342

Facility Contacts

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Andrea Carrillo

Role: primary

Other Identifiers

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TDCS2011

Identifier Type: -

Identifier Source: org_study_id

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