Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation (CSP#468F)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Department of Veterans Affairs
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: November 25, 2009
Last updated: November 25, 2014
Last verified: November 2014

November 25, 2009
November 25, 2014
June 2010
March 2015   (final data collection date for primary outcome measure)
Off-medication/on-stimulation Motor Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) [ Time Frame: 7-13 years post implant ] [ Designated as safety issue: No ]
Off-medication/on-stimulator Motor Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) [ Time Frame: Seven year post implant ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01022073 on Archive Site
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Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
CSP #468F - Long Term Study of Deep Brain Stimulation for Parkinson's Disease: A Longitudinal Follow-Up Study of the VA/NINDS CSP #468 Cohort

Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease

Parkinson's disease (PD), the second most prevalent neurodegenerative disease (after Alzheimer's disease), affects more than a million Americans and is a common condition in the Veteran population. Although there is currently no cure for the disease, many of the symptoms of the disease can be effectively managed with medications and with deep brain stimulation (DBS). This study seeks to build upon the original CSP#468 protocol by providing an efficient long-term follow-up study. The objectives of this study are to:

determine whether the motor benefits of deep brain stimulation persist beyond two years of follow-up in patients with Parkinson's disease; determine whether the target of stimulation (GPi vs. STN) affects the durability of long-term motor improvement; define the impact of DBS on long-term function and quality of life in patients with Parkinson's disease; identify clinical features that predict favorable or unfavorable long-term outcome; and describe the long-term performance of the DBS devices, including device durability, device explanation rate, neurostimulator replacement frequency, and changes in stimulation parameters to achieve optimum symptom control.

Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.

Parkinson Disease
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Group 1
Cohort of subjects who received DBS as part of the CSP 468 intervention trial, and still have their device working and in place.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participant in CSP#468
  • Available and willing to be followed-up according to study protocol

Exclusion Criteria:

  • DBS device explanted or permanently turned off without anticipated resumption of DBS therapy.
21 Years to 95 Years
Contact: Elaine Lanier, MS (415) 221-4810 ext 6488
Contact: Susan L Heath, RN (415) 221-4810 ext 2505
United States
Department of Veterans Affairs
Department of Veterans Affairs
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: William J. Marks, MD VA Medical Center, San Francisco
Department of Veterans Affairs
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP