Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029666
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-01-17
Brief Title:
Study of Repetitive Transcranial Magnetic Stimulation in Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Placebo Controlled Study of Repetitive Transcranial Magnetic Stimulation rTMS for the Treatment of Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of repetitive transcranial magnetic stimulation rTMS on Parkinsons 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 Parkinsons 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 Parkinsons 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 4-12 week period Patients will take their Parkinsons 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
Patients between 40 and 80 years of age with moderately severe Parkinsons 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 4-12 week period Patients will take their Parkinsons 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
Detailed Description:
The treatment of Parkinsons disease PD needs further improvement particularly in the area of gait and freezing A promising technique is repetitive transcranial magnetic stimulation rTMS that so far has produced small effects on bradykinesia in drug free patients in limited trials We hypothesize that rTMS will have a beneficial effect on gait and freezing in medicated patients and propose to test this in a controlled trial Specifically we propose to look at the effect of 25 Hz stimulation since this type of stimulation has been shown to increase the excitability of the cerebral cortex Over a one-year period we will enroll 40 adults with PD and evaluate the effects 8 treatments over a period of 4 weeks We will investigate effects on the motor cortex and the dorsolateral prefrontal cortex since both of these regions may be underactivated in PD and recent data suggest a change in diencephalic dopamine function with rTMS of the prefrontal cortex Symptoms will be evaluated with standard tests of motor function including the Unified Parkinsons Disease Rating Scale and specific tests of gait and freezing We will look for acute effects of stimulation and for cumulative effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0105 | None | None | None |