Trial Outcomes & Findings for Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation (NCT NCT01022073)
NCT ID: NCT01022073
Last Updated: 2016-06-10
Results Overview
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.
COMPLETED
156 participants
The change score of UPDRS Part III from baseline to 9 years post surgery
2016-06-10
Participant Flow
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.
This is follow-up study from the original study CSP#468.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
70
|
|
Overall Study
COMPLETED
|
67
|
52
|
|
Overall Study
NOT COMPLETED
|
19
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
Baseline characteristics by cohort
| Measure |
Globus Pallidus Interna Group
n=86 Participants
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
n=70 Participants
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
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
58.6 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
59.1 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=99 Participants
|
70 participants
n=107 Participants
|
156 participants
n=206 Participants
|
|
Married Status
Married
|
65 participants
n=99 Participants
|
49 participants
n=107 Participants
|
114 participants
n=206 Participants
|
|
Married Status
Single/Never Married
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Married Status
Seperated
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Married Status
Divorced
|
16 participants
n=99 Participants
|
19 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Living with Family
Alone
|
6 participants
n=99 Participants
|
9 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Living with Family
With Family
|
75 participants
n=99 Participants
|
57 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Living with Family
With Non-Family
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Living with Family
Nursing
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Family history of Parkinson's Disease
yes
|
19 participants
n=99 Participants
|
20 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Family history of Parkinson's Disease
no
|
67 participants
n=99 Participants
|
50 participants
n=107 Participants
|
117 participants
n=206 Participants
|
|
Years since Parkinson's Disease diagnosis
|
11.4 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
11.4 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
11.4 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Years on Parkinson's Disease medications
|
11.0 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
10.6 years
STANDARD_DEVIATION 4.7 • n=107 Participants
|
10.8 years
STANDARD_DEVIATION 4.7 • n=206 Participants
|
PRIMARY outcome
Timeframe: The change score of UPDRS Part III from baseline to 9 years post surgeryPopulation: Patients had completed the 9 year follow-up 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.
Outcome measures
| Measure |
Globus Pallidus Interna Group
n=50 Participants
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
n=28 Participants
Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
|
|---|---|---|
|
Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)
|
-8.2 units on a scale
Standard Deviation 14.6
|
-9.1 units on a scale
Standard Deviation 14.2
|
Adverse Events
Globus Pallidus Interna Group
Subthalamic Nucleus Group
Serious adverse events
| Measure |
Globus Pallidus Interna Group
n=86 participants at risk
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
n=70 participants at risk
Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
|
|---|---|---|
|
Surgical and medical procedures
Elective Hospitalization
|
2.3%
2/86 • Number of events 2
This study only collected study related serious adverse events given that there is no intervention.
|
2.9%
2/70 • Number of events 2
This study only collected study related serious adverse events given that there is no intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
William J. Marks, Jr., M.D.
San Francisco VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place