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
Results First Received: March 31, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Parkinson Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The original study CSP #468 visits were completed in October 2008, and the kick-off meeting for the follow-up study was held on April 26-28, 2010. Out of the total randomized 299 participants in the main study of CSP#468, 156 participants enrolled in this follow-up study. Subject recruitment started in August 2010 and ended in September 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is follow-up study from the original study CSP#468.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Globus Pallidus Interna Group     Subthalamic Nucleus Group  
STARTED     86     70  
COMPLETED     67     52  
NOT COMPLETED     19     18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Globus Pallidus Interna Group     Subthalamic Nucleus Group     Total  
Number of Participants  
[units: participants]
  86     70     156  
Age  
[units: years]
Mean (Standard Deviation)
  59.5  (8.4)     58.6  (7.9)     59.1  (8.2)  
Gender  
[units: participants]
     
Female     11     12     23  
Male     75     58     133  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     1     3     4  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     1     1  
White     84     66     150  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     86     70     156  
Married Status  
[units: participants]
     
Married     65     49     114  
Single/Never Married     4     2     6  
Seperated     1     0     1  
Divorced     16     19     35  
Living with Family  
[units: participants]
     
Alone     6     9     15  
With Family     75     57     132  
With Non-Family     5     3     8  
Nursing     0     1     1  
Family history of Parkinson's Disease  
[units: participants]
     
yes     19     20     39  
no     67     50     117  
Years since Parkinson's Disease diagnosis  
[units: years]
Mean (Standard Deviation)
  11.4  (4.7)     11.4  (5.2)     11.4  (4.9)  
Years on Parkinson's Disease medications  
[units: years]
Mean (Standard Deviation)
  11.0  (4.7)     10.6  (4.7)     10.8  (4.7)  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: William J. Marks, Jr., M.D.
Organization: San Francisco VA Medical Center
phone: 415-750-2100
e-mail: William.Marks@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022073     History of Changes
Other Study ID Numbers: 468F
Study First Received: November 25, 2009
Results First Received: March 31, 2016
Last Updated: May 4, 2016
Health Authority: United States: Federal Government