Childhood Onset DystoniasPhase 2NCT01460771
Transcranial Direct-Current Stimulation in Childhood Dystonia
A Phase 2 study testing TDCS (Transcranial Direct-current Stimulation) in people with Childhood Onset Dystonias, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Childhood Onset Dystonias
- What is being tested?
- TDCS (Transcranial Direct-current Stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- dystonia affecting one or both hands
- age 4 to 21 years
Who cannot join
- metal implants in the head
- inability to cooperate with instructions
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Andrea Carrillo
Terence D Sanger, MD, PhD
About this study
Official title: Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia
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.
- Conditions
- Childhood Onset Dystonias
- Being tested
- TDCS (Transcranial Direct-current Stimulation), sham TDCS (Transcranial Direct-current Stimulation)
- Keywords
- childhood dystonia
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDCS (Transcranial Direct-current Stimulation)Device
Also called eldith DC-stimulator (neuroconn, Ilmenau, Germany)
active TDCS
sham TDCS (Transcranial Direct-current Stimulation)Device
Also called eldith DC-stimulator (neuroconn, Ilmenau, Germany)
TDCS at 0mA
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current Receives: Device: TDCS (Transcranial Direct-current Stimulation) |
| sham | Sham comparator | inactive Transcranial Direct current stimulation (TDCS) at 0mA Receives: Device: sham TDCS (Transcranial Direct-current Stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand muscle overflow
surface EMG measure of overflow into muscles during attempted relaxation.
Measured: 10 minutes post- transcranial Direct-current Stimulation (TDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Onset DystoniasStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Crowley Carter Foundation, Don and Linda Carter Foundation
- Responsible party
- Principal investigator, Terence Sanger, University of Southern California
- Investigators
- Terence Sanger, MD, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460771
- Sponsor's protocol ID
- TDCS2011
- Status last verified
- May 2014
- First submitted
- 27 Sep 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open-label and Blinded Clinical Trial of Transcranial Direct-current Stimulation in Childhood Dystonia
- ClinicalTrials.gov ID
- NCT01460771
- Acronym / sponsor ID
- TDCS2011
- Conditions
- Childhood Onset Dystonias
- Keywords
- childhood dystonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Crowley Carter Foundation, Don and Linda Carter Foundation
- Study start
- Sep 2011
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: TDCS (Transcranial Direct-current Stimulation)Active Transcranial Direct Current Stimulation (TDCS) at 1mA or highest tolerated current |
| sham | Sham comparator | Device: sham TDCS (Transcranial Direct-current Stimulation)inactive Transcranial Direct current stimulation (TDCS) at 0mA |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- dystonia affecting one or both hands
- age 4 to 21 years
Key exclusion criteria (2 listed)
- metal implants in the head
- inability to cooperate with instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDCS (Transcranial Direct-current Stimulation)Also: eldith DC-stimulator (neuroconn, Ilmenau, Germany)active TDCS | Device | Treatment |
| sham TDCS (Transcranial Direct-current Stimulation)Also: eldith DC-stimulator (neuroconn, Ilmenau, Germany)TDCS at 0mA | Device | sham |
Primary outcome
Hand muscle overflow
Time frame: 10 minutes post- transcranial Direct-current Stimulation (TDCS)
surface EMG measure of overflow into muscles during attempted relaxation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence Sanger, MD, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDCS (Transcranial Direct-current Stimulation) in people with Childhood Onset Dystonias, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aprille Tongol (213-740-1317, tongol@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand muscle overflow (time frame: 10 minutes post- transcranial Direct-current Stimulation (TDCS)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.