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Original Contribution
January 7, 2009

Bilateral Deep Brain Stimulation vs Best Medical Therapy for Patients With Advanced Parkinson Disease: A Randomized Controlled Trial

Author Affiliations

Author Affiliations: Center for Management of Complex Chronic Care (Dr Weaver) and Cooperative Studies Coordinating Center (Drs Hur and Reda), Hines VA Hospital, Hines, Illinois; Department of Neurology, Northwestern University, Chicago, Illinois (Dr Weaver); Department of Neurosurgery, University of Nebraska, Omaha (Dr Follett); Department of Neurology, University of Pennsylvania Health System, Philadelphia (Drs Stern, Duda, and Horn); Philadelphia VA Medical Center, Philadelphia, Pennsylvania (Drs Stern and Duda); VA Cooperative Studies Program, Clinical Research Pharmacy, Albuquerque, New Mexico (Dr Harris); San Francisco VA Medical Center, San Francisco, California (Drs Marks and Rothlind); Departments of Neurology (Dr Marks) and Psychiatry (Dr Rothlind), University of California, San Francisco; Department of Neurosurgery, University of Michigan Medical Center, Ann Arbor (Dr Sagher); National Institute of Neurological Disorders and Stroke, Rockville, Maryland (Drs Moy and Heemskerk); Department of Neurology, University of Kansas Medical Center, Kansas City (Dr Pahwa); Portland VA Medical Center, Portland, Oregon (Drs Burchiel and Hogarth); Departments of Neurosurgery (Dr Burchiel) and Neurology (Dr Hogarth), Oregon Health and Science University, Portland; Michael E. DeBakey VA Medical Center, Houston, Texas (Dr Lai); Department of Neurology, Baylor College of Medicine, Houston, Texas (Dr Lai); Richmond VA Medical Center, Richmond, Virginia (Dr Holloway); Department of Neurosurgery, Virginia Commonwealth University, Richmond (Dr Holloway); Puget Sound Health Care System, Seattle, Washington (Dr Samii); West Los Angeles VA Medical Center, Los Angeles, California (Dr Bronstein); Department of Neurosurgery, University of Iowa Health Care, Iowa City (Ms Stoner); and Department of Veterans Affairs, Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC (Dr Huang).

JAMA. 2009;301(1):63-73. doi:10.1001/jama.2008.929

Context Deep brain stimulation is an accepted treatment for advanced Parkinson disease (PD), although there are few randomized trials comparing treatments, and most studies exclude older patients.

Objective To compare 6-month outcomes for patients with PD who received deep brain stimulation or best medical therapy.

Design, Setting, and Patients Randomized controlled trial of patients who received either deep brain stimulation or best medical therapy, stratified by study site and patient age (<70 years vs ≥70 years) at 7 Veterans Affairs and 6 university hospitals between May 2002 and October 2005. A total of 255 patients with PD (Hoehn and Yahr stage ≥2 while not taking medications) were enrolled; 25% were aged 70 years or older. The final 6-month follow-up visit occurred in May 2006.

Intervention Bilateral deep brain stimulation of the subthalamic nucleus (n = 60) or globus pallidus (n = 61). Patients receiving best medical therapy (n = 134) were actively managed by movement disorder neurologists.

Main Outcome Measures The primary outcome was time spent in the “on” state (good motor control with unimpeded motor function) without troubling dyskinesia, using motor diaries. Other outcomes included motor function, quality of life, neurocognitive function, and adverse events.

Results Patients who received deep brain stimulation gained a mean of 4.6 h/d of on time without troubling dyskinesia compared with 0 h/d for patients who received best medical therapy (between group mean difference, 4.5 h/d [95% CI, 3.7-5.4 h/d]; P < .001). Motor function improved significantly (P < .001) with deep brain stimulation vs best medical therapy, such that 71% of deep brain stimulation patients and 32% of best medical therapy patients experienced clinically meaningful motor function improvements (≥5 points). Compared with the best medical therapy group, the deep brain stimulation group experienced significant improvements in the summary measure of quality of life and on 7 of 8 PD quality-of-life scores (P < .001). Neurocognitive testing revealed small decrements in some areas of information processing for patients receiving deep brain stimulation vs best medical therapy. At least 1 serious adverse event occurred in 49 deep brain stimulation patients and 15 best medical therapy patients (P < .001), including 39 adverse events related to the surgical procedure and 1 death secondary to cerebral hemorrhage.

Conclusion In this randomized controlled trial of patients with advanced PD, deep brain stimulation was more effective than best medical therapy in improving on time without troubling dyskinesias, motor function, and quality of life at 6 months, but was associated with an increased risk of serious adverse events.

Trial Registration clinicaltrials.gov Identifier: NCT00056563