Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

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

Key facts

Study ID

NCT00056563

Run by

US Department of Veterans Affairs

People needed

255

Starts

2002-04-01

Expected to finish

2008-10-01

Last updated by the study team

2014-05-09

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• idiopathic Parkinson's disease,
• Hoehn and Yahr stage 2 or worse "off" medications,
• L-dopa responsive but with persistent disabling symptoms (i.e., refractory to "best medical treatment" with motor fluctuations, dyskinesias),
• on stable medical therapy for at least one month prior to enrollment,
• age > 21,
• available and willing to be followed-up according to study protocol, and
• no intracranial abnormalities that would contraindicate surgery (based on pre-operative magnetic resonance imaging of the brain).

You may not qualify if…

• "Parkinson's plus" syndromes,
• medical contraindications to surgery or stimulation,
• active alcohol or drug abuse,
• score on minimental status exam 24 or lower, or other neuropsychological dysfunction (e.g., dementia) that would contraindicate surgery,
• concurrent participation in another research protocol.

Where it is running

• University of California at Los Angeles — Los Angeles, California, United States
• VA Medical Center, San Francisco — San Francisco, California, United States
• University of California at San Francisco — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
• VA Medical Center, Iowa City — Iowa City, Iowa, United States
• VA Medical Center, Portland — Portland, Oregon, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• VA Medical Center, Philadelphia — Philadelphia, Pennsylvania, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• Michael E. DeBakey VA Medical Center (152) — Houston, Texas, United States
• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
• Medical College of Virginia — Richmond, Virginia, United States
• VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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