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
Parkinson's Disease	Procedure: Bilateral Deep Brain Stimulation	Phase III

Further Study Details: 

Expected Total Enrollment:  316

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.

Ages Eligible for Study:  22 Years and above,  Genders Eligible for Study:  Both

Criteria

INCLUSION:

• 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).

EXCLUSION:

• "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.

Gatana Stoner, R.N. CCRC      (319) 353-6679    gatana-stoner@uiowa.edu

California
      San Francisco VA Medical Center, San Francisco,  California,  United States; Recruiting
      University of California at Los Angeles, Los Angeles,  California,  United States; Recruiting
      University of California at San Francisco, San Francisco,  California,  United States; Recruiting
      West Los Angeles VA Medical Center, West Los Angeles,  California,  United States; Recruiting
Florida
      University of South Florida, Tampa,  Florida,  United States; Recruiting
Iowa
      Iowa City Veterans Administration Medical Center and the University of Iowa Health Care, Iowa City,  Iowa,  United States; Not yet recruiting
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  United States; Recruiting
      Portland VA Medical Center, Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  United States; Recruiting
      Philadelphia VA Medical Center, Philadelphia,  Pennsylvania,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  United States; Recruiting
      Houston VA Medical Center, Houston,  Texas,  United States; Recruiting
Virginia
      Medical College of Virginia, Richmond,  Virginia,  United States; Recruiting
      Richmond VA Medical Center, Richmond,  Virginia,  United States; Recruiting
Washington
      Seattle-Puget Sound Health Care System, Seattle,  Washington,  United States; Recruiting

Study chairs or principal investigators

Kenneth Follett, M.D., Ph.D.,  Principal Investigator,  Iowa City Veterans Administration Medical Center and the University of Iowa Health Care   
Frances M. Weaver, Ph.D.,  Principal Investigator,  Midwest Center for Health Services and Policy Research, Hines VA Hospital and Northwestern University   
Matthew Stern, M.D.,  Principal Investigator,  University of Pennsylvania Hospital and Philadelphia VA Medical Center   

Study ID Numbers:  VA-NINDS-01
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  March 18, 2003
ClinicalTrials.gov Identifier:  NCT00056563
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08