Phase II Subthalamic Nucleus (STN) vs. Globus Pallidus (GPi) Trial

Completed · Phase 3

Conditions studied: Parkinson's Disease

In brief

The goal of the second phase of the study is to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of Parkinson's Disease.

Key facts

Study ID

NCT01076452

Run by

US Department of Veterans Affairs

People needed

299

Starts

2002-04-01

Expected to finish

2009-04-01

Last updated by the study team

2014-07-14

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 when off medications
• L-dopa responsive with clearly defined "on" periods (i.e. symptoms improve at least partially with L-dopa administration, a characteristic that helps distinguish idiopathic PD from "Parkinson's Plus" and atypical Parkinson's syndromes-see below)
• persistent disabling symptoms (e.g. on troubling dyskinesias, or disabling "off" periods at least 3 hours/day) despite medication therapy. Patients will have been treated with variable doses of levodopa and dopamine agonists (at a minimum) and will have had an adequate trial of other adjunctive medications)
• stable on medical therapy for at least one month prior to study enrollment
• age >21
• available and willing to be followed-up according to study protocol

You may not qualify if…

• "Parkinson's plus" syndromes, secondary, or atypical Parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic Parkinson's. These patients have cardinal symptoms characteristic of PD but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to L-dopa, these individuals tend not to improve with standard treatments for PD)
• previous Parkinson's Disease surgery
• medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (Note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility)
• contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by MRI)
• active alcohol or drug abuse
• score on Mini-Mental Status examination of 24 or lower, or other neuropsychological dysfunction 9e.g. dementia) that would contraindicate surgery
• intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)
• pregnancy
• concurrent participation in another research protocol

Where it is running

• University of California at Los Angeles — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• VA Medical Center, 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
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Philadelphia, OPC — 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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