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NCT00106782 · ClinicalTrials.gov registry record · Phase 2
Transcranial Electrical Polarization to Treat Focal Hand Dystonia
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00106782 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 12 participants.
The verdict
NCT00106782, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study will evaluate the effect of transcranial electrical polarization (TEP), also called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one part of the body, such as the hand, neck or face. When people with focal hand dystonia make small and repeated movements with their hands, there is extra activity in the part of the brain called the motor cortex. TEP is a method of brain stimulation that slows down the activity of the nerve cells in the motor cortex. This study may help researchers develop new ways to treat focal hand dystonia. People 18 years of age and older with focal hand dystonia may be eligible for this study. Participants have a neurological examination and are randomly assigned to one of two treatment groups: TEP or placebo stimulation. The TEP group receives stimulation to the parts of the brain used for hand movement, and the placebo group receives sham stimulation, which does not affect any area of the brain. There are three TEP/placebo sessions over a period of 7 to 10 days. The first session may last up to 2-1/2 hours; the other two sessions last 1-2 hours. For TEP, sponge electrodes are placed on the scalp and an electrical current is passed through the scalp and skull to the outer part of brain. Before and after each session, participants have a neurological examination, including an evaluation of the rate and severity of their movement problems. For this assessment, participants do a writing test while the electrical activity of their hand muscles is recorded using surface electromyography (EMG). For EMG, small metal disks (electrodes) filled with a conductive gel are taped to the skin over the muscles being tested. Patients are followed in the clinic the day after the end of TEP treatment for evaluation of their movement abilities and the effects of therapy, such as imp
Interventions
- PROCEDURE Transcranial Electrical Polarization (TEP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2005-03-18 |
| Est. Completion | 2010-05-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00106782
The ClinicalTrials.gov registry entry for NCT00106782 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transcranial Electrical Polarization (TEP) is the first listed.
NCT00106782 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00106782 about?
NCT00106782 is a clinical study titled "Transcranial Electrical Polarization to Treat Focal Hand Dystonia". This study will evaluate the effect of transcranial electrical polarization (TEP), also called direct current (DC) stimulation, on focal hand dystonia in people with writer's cramp. In dystonia, muscle spasms cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia in...
What is the current status of trial NCT00106782?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2005-03-18. Estimated completion is 2010-05-14.
What interventions are being tested in trial NCT00106782?
The interventions under investigation include: Transcranial Electrical Polarization (TEP) (PROCEDURE).
Who is sponsoring clinical trial NCT00106782?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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