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Sponsors and Collaborators: |
The Cleveland Clinic National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00053625 |
The purpose of this trial is to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) and the subthalamic nucleus (STN) on motor, neuropsychological and psychiatric function, and quality of life in patients with Parkinson's disease.
Condition | Intervention | Phase |
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Parkinson's Disease |
Procedure: deep brain stimulation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Deep Brain Stimulation for Parkinson's Disease Trial |
Estimated Enrollment: | 132 |
Study Start Date: | June 1999 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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S.A.1: Active Comparator
compare the relative benefit of unilateral DBS in the GPi or STN
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Procedure: deep brain stimulation
Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms—most commonly the debilitating symptoms of Parkinson's disease (PD). In Arm S.A.1: Primary outcome variable will be the change in the UPDRS total score from baseline to 6 months post-surgery. In Arm S.A.2: For bilateral DBS the second implant site will be the same as that for the first procedure (i.e. either STN or GPi) in order to allow comparison between bilateral STN and GPi stimulation. |
S.A.2: Active Comparator
access the effect of bilateral GPi or STN stimulation in patients having previously undergone unilateral DBS in the GPi or STN
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Procedure: deep brain stimulation
Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms—most commonly the debilitating symptoms of Parkinson's disease (PD). In Arm S.A.1: Primary outcome variable will be the change in the UPDRS total score from baseline to 6 months post-surgery. In Arm S.A.2: For bilateral DBS the second implant site will be the same as that for the first procedure (i.e. either STN or GPi) in order to allow comparison between bilateral STN and GPi stimulation. |
Medical therapy is the mainstay of treatment for patients with Parkinson's disease (PD). After several years of drug therapy, however, a large proportion of patients experience worsening of their parkinsonism and develop incapacitating motor fluctuations and dyskinesias. To deal with this, attention has been directed to surgical procedures, such as deep brain stimulation (DBS). Recently, stimulating the areas of the brain that control movement--the globus pallidus (Gpi) and the subthalamic nucleus (STN)--has been proposed as a therapy for treating many of the disabling symptoms associated with PD and drug-induced side effects.
The major aim of this 5-year study is to carry out a prospective, double blinded, randomized, clinical trial of DBS for medically intractable PD. The study will evaluate the effect of DBS in the Gpi and STN on motor, neuropsychological and psychiatric function, and quality of life in patients with PD.
The study also will address two key issues: 1.) whether there are differences between unilateral Gpi-DBS and STN-DBS and 2.) which patients are the best candidates for bilateral DBS.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION:
EXCLUSION:
United States, Georgia | |
Emory University School of Medicine, Neurology Department | |
Atlanta, Georgia, United States, 30322 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Jerrold L Vitek, M.D., Ph.D. | Cleveland Clinic Foundation, Director - Functional Neuroscience Research Center |
Principal Investigator: | Mahlon R. DeLong, M.D. | Emory University |
Responsible Party: | Cleveland Clinic ( Jerrold Vitek, M.D., Ph.D. ) |
Study ID Numbers: | R01NS37959 |
Study First Received: | February 4, 2003 |
Last Updated: | February 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00053625 History of Changes |
Health Authority: | United States: Federal Government |
Parkinson's disease PD deep brain stimulation DBS |
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |