Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation, Subthalamic Nucleus, Globus Pallidus, Parkinson Disease
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.
Interventions
None listed
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 86 |
| 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. | 70 |
| Total | 156 |
Baseline characteristics
| Characteristic | Globus Pallidus Interna Group | Subthalamic Nucleus Group | Total |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 8.4 | 58.6 years STANDARD_DEVIATION 7.9 | 59.1 years STANDARD_DEVIATION 8.2 |
| Family history of Parkinson's Disease no | 67 participants | 50 participants | 117 participants |
| Family history of Parkinson's Disease yes | 19 participants | 20 participants | 39 participants |
| Living with Family Alone | 6 participants | 9 participants | 15 participants |
| Living with Family Nursing | 0 participants | 1 participants | 1 participants |
| Living with Family With Family | 75 participants | 57 participants | 132 participants |
| Living with Family With Non-Family | 5 participants | 3 participants | 8 participants |
| Married Status Divorced | 16 participants | 19 participants | 35 participants |
| Married Status Married | 65 participants | 49 participants | 114 participants |
| Married Status Seperated | 1 participants | 0 participants | 1 participants |
| Married Status Single/Never Married | 4 participants | 2 participants | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 66 Participants | 150 Participants |
| Region of Enrollment United States | 86 participants | 70 participants | 156 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 75 Participants | 58 Participants | 133 Participants |
| Years on Parkinson's Disease medications | 11.0 years STANDARD_DEVIATION 4.7 | 10.6 years STANDARD_DEVIATION 4.7 | 10.8 years STANDARD_DEVIATION 4.7 |
| Years since Parkinson's Disease diagnosis | 11.4 years STANDARD_DEVIATION 4.7 | 11.4 years STANDARD_DEVIATION 5.2 | 11.4 years STANDARD_DEVIATION 4.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 2 / 86 | 2 / 70 |
Outcome results
Primary
Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)
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
Population: Patients had completed the 9 year follow-up post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Globus Pallidus Interna Group | 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 |
| Subthalamic Nucleus Group | Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) | -9.1 units on a scale | Standard Deviation 14.2 |
p-value: 0.808t-test, 2 sided