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

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ClinicalTrials.gov Identifier: NCT01022073
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date November 25, 2009
First Posted Date December 1, 2009
Results First Submitted Date March 31, 2016
Results First Posted Date June 10, 2016
Last Update Posted Date June 10, 2016
Study Start Date June 2010
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2016)
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 ]
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.
Original Primary Outcome Measures
 (submitted: November 30, 2009)
Off-medication/on-stimulator Motor Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) [ Time Frame: Seven year post implant ]
Change History Complete list of historical versions of study NCT01022073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
Official Title 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
Brief Summary Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 13, 2015)
156
Original Estimated Enrollment
 (submitted: November 30, 2009)
261
Actual Study Completion Date April 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01022073
Other Study ID Numbers 468F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: We can share the data based on the VA approved Data Use Agreement(DUA)
Responsible Party VA Office of Research and Development
Study Sponsor VA Office of Research and Development
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Study Chair: William J. Marks, MD San Francisco VA Medical Center, San Francisco, CA
PRS Account VA Office of Research and Development
Verification Date May 2016