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

PHASE3CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

April 30, 2002

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Parkinson's Disease
Interventions
DEVICE

Bilateral Deep Brain Stimulation

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.

OTHER

best medical therapy

"Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."

Trial Locations (14)

19104

VA Medical Center, Philadelphia, Philadelphia

19107

Pennsylvania Hospital, Philadelphia

23249

Hunter Holmes McGuire VA Medical Center, Richmond

23298

Medical College of Virginia, Richmond

77030

Baylor College of Medicine, Houston

Michael E. DeBakey VA Medical Center (152), Houston

90073

VA Greater Los Angeles Healthcare System, West LA, West Los Angeles

90095

University of California at Los Angeles, Los Angeles

94121

VA Medical Center, San Francisco, San Francisco

94143

University of California at San Francisco, San Francisco

97201

VA Medical Center, Portland, Portland

97239

Oregon Health Sciences University, Portland

98108

VA Puget Sound Health Care System, Seattle, Seattle

52246-2208

VA Medical Center, Iowa City, Iowa City

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

US Department of Veterans Affairs

FED

NCT00056563 - Phase I Deep Brain Stimulation (DBS) vs. Best Medical Therapy (BMT) Trial | Biotech Hunter | Biotech Hunter