JSM 2005 - Toronto

Abstract #304309

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 257
Type: Topic Contributed
Date/Time: Tuesday, August 9, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #304309
Title: The Design of the VA/NINDS Randomized Clinical Trial of Deep Brain Stimulation for Treatment of Parkinson's Disease
Author(s): Domenic Reda*+ and Kwan Hur and Kenneth Follett and Frances Weaver and Matthew Stern and Crystal Harris
Companies: U.S. Department of Veterans Affairs and U.S. Department of Veterans Affairs and University of Nebraska Medical Center and VA Hospital and VA Medical Center and VA Medical Center
Address: 53 Chesterfield Court, Cooperative Studies Program, Burr Ridge, IL, 60527, United States
Keywords: Randomized Clinical Trials ; Medical Devices ; Deep Brain Stimulation ; Parkinson's Disease
Abstract:

A common problem in the design and conduct of randomized clinical trials is the lengthy time often seen between study planning and publication of results. This is particularly problematic in rapidly evolving medical specialties where a study may become obsolete before its completion. One example is in the treatment of advanced Parkinson's Disease when medications are no longer sufficient to control symptoms. In a relatively short time, pallidotomy---an ablative surgical intervention---came into widespread use before being replaced rapidly with deep brain stimulation (DBS), involving a functional lesion. Further, DBS devices have undergone technical improvements since their introduction. In the VA/NINDS Trial of Deep Brain Stimulation for the Treatment of Parkinson's Disease, the original study design underwent major modifications twice before data collection began because of these major shifts. Following study implementation, further revisions in the study design and conduct were needed to address changes in the regulatory status of the devices. his talk will trace the evolution of the study design and the events that transpired necessitating these revisions.

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Revised March 2005