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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01022073
First received: November 25, 2009
Last updated: May 4, 2016
Last verified: May 2016

November 25, 2009
May 4, 2016
June 2010
March 2015   (final data collection date for primary outcome measure)
Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) [ Time Frame: The change score of UPDRS Part III from baseline to 9 years post surgery ] [ Designated as safety issue: No ]
The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher the value, the worse the outcome.
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 ClinicalTrials.gov 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
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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  • Globus Pallidus interna Group
    Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
  • Subthalamic Nucleus Group
    Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
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.
Both
21 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01022073
468F
Yes
Undecided
We can share the data based on the VA approved Data Use Agreement(DUA)
VA Office of Research and Development
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Study Chair: William J. Marks, MD San Francisco VA Medical Center, San Francisco, CA
VA Office of Research and Development
May 2016

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