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NCT00132340 · ClinicalTrials.gov registry record · Phase 1
Deep Brain Stimulation to Treat Cervical Dystonia
A Phase 1 study of Cervical Dystonia, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00132340 is a Phase 1 study of Cervical Dystonia that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 40 participants, below the 84-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00132340, a Phase 1 study of Cervical Dystonia, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effectiveness of deep brain stimulation (DBS) for treating primary 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 globus pallidus interna (Gpi) and subthalamic nucleus (STN) - areas of the basal ganglia of the brain that do not work correctly in patients with dystonia. This results in decreased movement and therefore may lessen patients' symptoms and pain. The study will also examine the physiology of dystonia and determine whether the treatment effects of DBS in the Gpi differ significantly from DBS of the STN. Patients 18 years of age and older with primary cervical dystonia that does not respond to medical treatment or botulinum toxin (Botox) may be eligible for this study. Candidates are screened with blood and urine tests, chest x-ray, electrocardiogram, and magnetic resonance imaging (MRI, see below) of the brain. Each participant undergoes the following tests and procedures: * Magnetic resonance imaging. This procedure is done after implantation of the stimulators to verify position of the electrodes. 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 t
Conditions Studied
Interventions
- DEVICE Electrodes
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-08 |
| Est. Completion | 2006-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00132340
The ClinicalTrials.gov registry entry for NCT00132340 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 84-participant average among 15 other Cervical Dystonia trials with a reported enrollment target (52% lower). 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 1 condition, with Cervical Dystonia appearing as the primary indexed condition, and to 1 intervention - of which Electrodes is the first listed.
NCT00132340 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00132340 about?
NCT00132340 is a clinical study titled "Deep Brain Stimulation to Treat Cervical Dystonia". This study will evaluate the effectiveness of deep brain stimulation (DBS) for treating primary 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...
What is the current status of trial NCT00132340?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2005-08. Estimated completion is 2006-07.
What conditions does trial NCT00132340 study?
This clinical trial studies the following conditions: Cervical Dystonia.
What interventions are being tested in trial NCT00132340?
The interventions under investigation include: Electrodes (DEVICE).
Who is sponsoring clinical trial NCT00132340?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00132340 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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