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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Parkinson Disease
Enrollment 156
Recruitment Details 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 This is follow-up study from the original study CSP#468.
Arm/Group Title Globus Pallidus Interna Group Subthalamic Nucleus Group
Hide Arm/Group Description Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place. Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
Period Title: Overall Study
Started 86 70
Completed 67 52
Not Completed 19 18
Arm/Group Title Globus Pallidus Interna Group Subthalamic Nucleus Group Total
Hide Arm/Group Description Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place. 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 of all reporting groups
Overall Number of Baseline Participants 86 70 156
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 70 participants 156 participants
59.5  (8.4) 58.6  (7.9) 59.1  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 156 participants
Female
11
  12.8%
12
  17.1%
23
  14.7%
Male
75
  87.2%
58
  82.9%
133
  85.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 156 participants
American Indian or Alaska Native
1
   1.2%
0
   0.0%
1
   0.6%
Asian
1
   1.2%
3
   4.3%
4
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   1.4%
1
   0.6%
White
84
  97.7%
66
  94.3%
150
  96.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants 70 participants 156 participants
86 70 156
Married Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 156 participants
Married 65 49 114
Single/Never Married 4 2 6
Seperated 1 0 1
Divorced 16 19 35
Living with Family  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 156 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 70 participants 156 participants
yes 19 20 39
no 67 50 117
Years since Parkinson's Disease diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 70 participants 156 participants
11.4  (4.7) 11.4  (5.2) 11.4  (4.9)
Years on Parkinson's Disease medications  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 70 participants 156 participants
11.0  (4.7) 10.6  (4.7) 10.8  (4.7)
1.Primary Outcome
Title Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)
Hide Description 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.
Time Frame The change score of UPDRS Part III from baseline to 9 years post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients had completed the 9 year follow-up post surgery
Arm/Group Title Globus Pallidus Interna Group Subthalamic Nucleus Group
Hide Arm/Group Description:
Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
Overall Number of Participants Analyzed 50 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
-8.2  (14.6) -9.1  (14.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Globus Pallidus Interna Group, Subthalamic Nucleus Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments [Not Specified]
Method t-test, 2 sided
Comments This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.
Time Frame [Not Specified]
Adverse Event Reporting Description This study only collected study related serious adverse events given that there is no intervention.
 
Arm/Group Title Globus Pallidus Interna Group Subthalamic Nucleus Group
Hide Arm/Group Description Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place. Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
All-Cause Mortality
Globus Pallidus Interna Group Subthalamic Nucleus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Globus Pallidus Interna Group Subthalamic Nucleus Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/86 (2.33%)      2/70 (2.86%)    
Surgical and medical procedures     
Elective Hospitalization * [1]  2/86 (2.33%)  2 2/70 (2.86%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Elective hospitalization are not medical events and are only scheduled to facilitate a safe study visit for the participants.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Globus Pallidus Interna Group Subthalamic Nucleus Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William J. Marks, Jr., M.D.
Organization: San Francisco VA Medical Center
Phone: 415-750-2100
EMail: William.Marks@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022073     History of Changes
Other Study ID Numbers: 468F
First Submitted: November 25, 2009
First Posted: December 1, 2009
Results First Submitted: March 31, 2016
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016