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NCT00105430 · ClinicalTrials.gov registry record · Phase 2
Deep Brain Stimulation for Cervical Dystonia
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00105430 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 40 participants.
The verdict
NCT00105430, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating primary generalized dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are available, but not all patients get adequate relief from the abnormal movements or the pain associated with them. DBS is a surgical procedure that interrupts neuronal circuits in the Gpi and STN, areas of the basal ganglia of the brain that do not work correctly in patients with dystonia. The surgery results in decreased movement and therefore may lessen patients' symptoms and pain. Patients 7 years of age and older with generalized dystonia that does not respond to medical treatment may be eligible for this study. Candidates are screened with blood and urine tests, chest x-ray, and an electrocardiogram in patients 35 years of age or more. Participants undergo the following tests and procedures: * Magnetic resonance imaging. MRI uses a magnetic field and radio waves to produce images of the brain. The patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure usually lasts about 45 to 90 minutes, during which the patient is asked to lie still for up to 15 minutes at a time. * Transcranial magnetic stimulation. This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the patient may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the patient may hear a click and feel a pulling sensation on the skin under the coil. During the stimulation, electrical activity of muscles is recorded with a computer, using electrodes attached to the sk
Interventions
- PROCEDURE Deep Brain Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105430
The ClinicalTrials.gov registry entry for NCT00105430 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 Deep Brain Stimulation is the first listed.
NCT00105430 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00105430 about?
NCT00105430 is a clinical study titled "Deep Brain Stimulation for Cervical Dystonia". This study will evaluate the effectiveness of deep brain stimulation (DBS) in treating primary generalized dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. Medical therapies are available, but not all patients get adeq...
What is the current status of trial NCT00105430?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-03. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00105430?
The interventions under investigation include: Deep Brain Stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT00105430?
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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