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.

Recruitment status

COMPLETED

Target enrollment

156 participants

Primary outcome timeframe

The change score of UPDRS Part III from baseline to 9 years post surgery

Results posted on

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

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

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
Living with Family With Family	75 participants n=5 Participants	57 participants n=7 Participants	132 participants n=5 Participants
Living with Family With Non-Family	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Living with Family Nursing	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Age, Continuous	59.5 years STANDARD_DEVIATION 8.4 • n=5 Participants	58.6 years STANDARD_DEVIATION 7.9 • n=7 Participants	59.1 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	58 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants	66 Participants n=7 Participants	150 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants	70 participants n=7 Participants	156 participants n=5 Participants
Married Status Married	65 participants n=5 Participants	49 participants n=7 Participants	114 participants n=5 Participants
Married Status Single/Never Married	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Married Status Seperated	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Married Status Divorced	16 participants n=5 Participants	19 participants n=7 Participants	35 participants n=5 Participants
Living with Family Alone	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Family history of Parkinson's Disease yes	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants
Family history of Parkinson's Disease no	67 participants n=5 Participants	50 participants n=7 Participants	117 participants n=5 Participants
Years since Parkinson's Disease diagnosis	11.4 years STANDARD_DEVIATION 4.7 • n=5 Participants	11.4 years STANDARD_DEVIATION 5.2 • n=7 Participants	11.4 years STANDARD_DEVIATION 4.9 • n=5 Participants
Years on Parkinson's Disease medications	11.0 years STANDARD_DEVIATION 4.7 • n=5 Participants	10.6 years STANDARD_DEVIATION 4.7 • n=7 Participants	10.8 years STANDARD_DEVIATION 4.7 • n=5 Participants

PRIMARY outcome

Timeframe: The change score of UPDRS Part III from baseline to 9 years post surgery

Population: Patients had completed the 9 year follow-up post surgery

Outcome measures

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

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Subthalamic Nucleus Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

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

Phone: 415-750-2100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place