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NCT00753519 · ClinicalTrials.gov registry record · Phase 1
Transcranial Magnetic Stimulation to Treat Parkinson's Disease
A Phase 1 study of Parkinson Disease, sponsored by Mark Hallett.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT00753519 is a Phase 1 study of Parkinson Disease that has completed, run by Mark Hallett. The registered enrollment target is 28 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00753519, a Phase 1 study of Parkinson Disease, has completed, sponsored by Mark Hallett.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of Parkinson's disease. TMS is a method of brain stimulation that may be able to change the activity of the nerve cells of the brain. This study will examine the effects of a specific pattern of stimulation called intermittent theta-burst TMS (iTBS), which uses repeated magnetic pulses delivered in short bursts. People with mild to moderately severe Parkinson's disease who are between 40 and 80 years of age and whose main problems are slow movement and stiffness may be eligible for this study. Participants undergo the following tests and procedures: * Random assignment to real or placebo (sham) iTBS treatment. * iTBS sessions (real or sham) 4 times a week for 2 consecutive weeks. For this test, the subject sits in a comfortable chair. A wire coil is held on the subject's scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. * Test of gait (walk), hand and arm movements before and after each session. The gait test requires walking 10 meters (about 30 yards) in the same corridor with the same shoes. * Extended testing. The first and last gait tests (done before starting iTBS and after the eighth session) require coming off any Parkinson's medication for at least 12 hours before the test. On these test days, subjects also undergo a clinical examination, short neuropsychological test battery, a computer-based reaction time test and depression and quality-of-life rating scales. These procedures are repeated in a follow-up visit 1 month after the last session.
Conditions Studied
Interventions
- DEVICE Sham iTBS
- DEVICE Real iTBS
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00753519
The ClinicalTrials.gov registry entry for NCT00753519 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is Mark Hallett, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Sham iTBS is the first listed.
NCT00753519 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00753519 about?
NCT00753519 is a clinical study titled "Transcranial Magnetic Stimulation to Treat Parkinson's Disease". This study will look at the effects of transcranial magnetic stimulation (TMS) on symptoms of Parkinson's disease. TMS is a method of brain stimulation that may be able to change the activity of the nerve cells of the brain. This study will examine the effects of a specific pattern of stimulation ca...
What is the current status of trial NCT00753519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-09. Estimated completion is 2009-09.
What conditions does trial NCT00753519 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT00753519?
The interventions under investigation include: Sham iTBS (DEVICE), Real iTBS (DEVICE).
Who is sponsoring clinical trial NCT00753519?
This trial is sponsored by Mark Hallett, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00753519 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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Related
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