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NCT00029666 · ClinicalTrials.gov registry record · Phase 2
Study of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00029666 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
NCT00029666, 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 examine the effects of repetitive transcranial magnetic stimulation (rTMS) on Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to change the electrical activity of the nerve cells in the brain. It has been proposed as a treatment for brain disorders, including Parkinson's disease. In preliminary studies, some patients' symptoms improved; in some they worsened temporarily, and some showed no change. Patients between 40 and 80 years of age with moderately severe Parkinson's disease, whose main problem is slowness of movement and stiffness, may be eligible for this study. Participants will be randomly assigned to one of two treatment groups: one will receive rTMS to parts of the brain involved in controlling movement; the other will receive sham, or placebo, stimulation. Nine treatments will be given over a 4-1/2 week period. Patients will take their Parkinson's disease medications during the study, but will stop taking the medicines for 4 to 5 hours before one of the sessions. For rTMS, an insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The pulses are delivered in trains, or short bursts, lasting 1 second each. There will be 48 trains for a total of 1200 pulses per 24-minute session. The stimulation may cause muscle twitching in the scalp or face and may also cause small movements of the limbs. Just before and after each rTMS session, patients will have a neurologic examination, including an evaluation of walking. Their motor function tests will be recorded on videotape to document possible improvement and to allow physicians to rate the improvement. The physicians will not know which patients are receiving actual rTMS and which are receiving sham treatment. Ratings before the first and after the last rTMS sessions will be more detailed.
Interventions
- DEVICE Neopulse Magnetic Stimulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2002-01 |
| Est. Completion | 2005-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00029666
The ClinicalTrials.gov registry entry for NCT00029666 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 Neopulse Magnetic Stimulator is the first listed.
NCT00029666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00029666 about?
NCT00029666 is a clinical study titled "Study of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease". This study will examine the effects of repetitive transcranial magnetic stimulation (rTMS) on Parkinson's disease symptoms. rTMS is a way of stimulating the brain that may be able to change the electrical activity of the nerve cells in the brain. It has been proposed as a treatment for brain disorde...
What is the current status of trial NCT00029666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2002-01. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00029666?
The interventions under investigation include: Neopulse Magnetic Stimulator (DEVICE).
Who is sponsoring clinical trial NCT00029666?
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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