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Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial
This study is currently recruiting patients.
Sponsored by: | Department of Veterans Affairs |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
Purpose
The goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving Parkinson's disease symptoms.
Condition | Treatment or Intervention | Phase |
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Parkinson's Disease |
Procedure: Bilateral Deep Brain Stimulation |
Phase III |
MedlinePlus related topics: Parkinson's Disease
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Comparison of Best Medical Therapy and Deep Brain Stimulation of Subthalamic Nucleus and Globus Pallidus for the Treatment of Parkinson's Disease
Expected Total Enrollment: 316
Study start: April 2002
Deep Brain Stimulation (DBS) is a promising therapy for Parkinson's disease (PD). Whether DBS is superior to comprehensive best medical therapy or whether some patients or symptoms respond better to DBS in one area of the brain or the other is currently not known.
The goals of this project are to compare the effectiveness of DBS and comprehensive medical therapy as treatments for PD, and to compare bilateral DBS at 2 areas of the brain--the subthalamic nucleus (STN) and the globus pallidus (Gpi)--to determine the most effective brain site for surgical intervention.
In this prospective, randomized, multi-center trial, 316 patients will be enrolled at 13 centers over two years. Patients will initially be randomized to immediate surgery (DBS) or to 6 months of "best medical therapy." Outcomes of DBS and BMT patients will be compared at 6 months. BMT patients will then proceed into the surgical phase of the trial. The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. Patients will be followed for two years post surgery (24-30 months). The findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of PD.
Eligibility
Ages Eligible for Study: 22 Years and above, Genders Eligible for Study: Both
Criteria
INCLUSION:
EXCLUSION:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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