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Tracking Information | |||||||||
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First Received Date † | February 4, 2003 | ||||||||
Last Updated Date | February 1, 2008 | ||||||||
Start Date † | June 1999 | ||||||||
Current Primary Outcome Measures † |
UPDRS testing [ Time Frame: followed for 5 years ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00053625 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Deep Brain Stimulation for Parkinson's Disease Trial | ||||||||
Official Title † | Deep Brain Stimulation for Parkinson's Disease Trial | ||||||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment | ||||||||
Condition † | Parkinson's Disease | ||||||||
Intervention † | Procedure: deep brain stimulation | ||||||||
Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 132 | ||||||||
Estimated Completion Date | June 2008 | ||||||||
Estimated Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | INCLUSION:
EXCLUSION:
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Gender | Both | ||||||||
Ages | 30 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00053625 | ||||||||
Responsible Party | Jerrold Vitek, M.D., Ph.D., Cleveland Clinic | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | The Cleveland Clinic | ||||||||
Collaborators †† | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
Investigators † |
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Information Provided By | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
Verification Date | February 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |