Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The change score of UPDRS Part III from baseline to 9 years post surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William J. Marks, MD | San Francisco VA Medical Center, San Francisco, CA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA-University of California at Los Angeles(904) | Los Angeles | California | 90095 | United States | ||
| San Francisco-University of California at San Francisco(905) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41626017 | Derived | Ostrem JL, Luo P, Weaver FM, Follett K, Rothlind J, Galifianakis NB, Lai EC, Bronstein J, Duda J, Holloway K, Sarwar A, Brodsky M, Chung K, Spindler M, Reda D, Snodgrass A, Moy C, Huang G, Wei Y, Marks WJ Jr; CSP 468F Study Group. 10-year clinical outcomes of subthalamic nucleus versus pallidal deep brain stimulation for Parkinson's disease: VA/NINDS CSP #468F. Front Neurol. 2026 Jan 16;16:1728999. doi: 10.3389/fneur.2025.1728999. eCollection 2025. |
Not provided
Not provided
We can share the data based on the VA approved Data Use Agreement(DUA)
Not provided
Not provided
Not provided
Not provided
This is follow-up study from the original study CSP#468.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Subthalamic Nucleus Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| San Francisco |
| California |
| 94115 |
| United States |
| San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | 94121 | United States |
| VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | 90073 | United States |
| VA Medical Center, Portland | Portland | Oregon | 97201 | United States |
| Portland-Oregon Health & science University(906) | Portland | Oregon | 97239 | United States |
| VA Medical Center, Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia-University of Pennsylvania Health System(901) | Philadelphia | Pennsylvania | 19107 | United States |
| Houston-Methodist Hospital(903) | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | United States |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Richmond-Medical college of Virginia(902) | Richmond | Virginia | 23298 | United States |
Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Married Status | Number | participants |
| ||||||||||||||||
| Living with Family | Number | participants |
| ||||||||||||||||
| Family history of Parkinson's Disease | Number | participants |
| ||||||||||||||||
| Years since Parkinson's Disease diagnosis | Mean | Standard Deviation | years |
| |||||||||||||||
| Years on Parkinson's Disease medications | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients had completed the 9 year follow-up post surgery | Posted | Mean | Standard Deviation | units on a scale | The change score of UPDRS Part III from baseline to 9 years post surgery |
|
|
|
|
Not provided
This study only collected study related serious adverse events given that there is no intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 86 | 0 | 0 | ||
| EG001 | 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. | 2 | 70 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elective Hospitalization | Surgical and medical procedures | Non-systematic Assessment | Elective hospitalization are not medical events and are only scheduled to facilitate a safe study visit for the participants. |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William J. Marks, Jr., M.D. | San Francisco VA Medical Center | 415-750-2100 | William.Marks@va.gov |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Single/Never Married |
|
| Seperated |
|
| Divorced |
|
| With Family |
|
| With Non-Family |
|
| Nursing |
|
| no |
|