Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
CSP#468F
CSP #468F - Long Term Study of Deep Brain Stimulation for Parkinson's Disease: A Longitudinal Follow-Up Study of the VA/NINDS CSP #468 Cohort
1 other identifier
observational
156
1 country
12
Brief Summary
Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2010
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 10, 2016
CompletedJune 10, 2016
May 1, 2016
4.8 years
November 25, 2009
March 31, 2016
May 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Eligibility Criteria
Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.
You may qualify if:
- Participant in CSP#468
- Available and willing to be followed-up according to study protocol
You may not qualify if:
- DBS device explanted or permanently turned off without anticipated resumption of DBS therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
UCLA-University of California at Los Angeles(904)
Los Angeles, California, 90095, United States
San Francisco-University of California at San Francisco(905)
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
Related Publications (1)
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.
PMID: 41626017DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- William J. Marks, Jr., M.D.
- Organization
- San Francisco VA Medical Center
Study Officials
- STUDY CHAIR
William J. Marks, MD
San Francisco VA Medical Center, San Francisco, CA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2009
First Posted
December 1, 2009
Study Start
June 1, 2010
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
June 10, 2016
Results First Posted
June 10, 2016
Record last verified: 2016-05