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 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Official Title:||Placebo Controlled Study of Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Parkinson's Disease|
|Study Start Date:||January 2002|
|Estimated Study Completion Date:||March 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029666
|United States, Maryland|
|National Institute of Neurological Disorders and Stroke (NINDS)|
|Bethesda, Maryland, United States, 20892|