Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation (CSP#468F)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01022073 |
Recruitment Status
:
Completed
First Posted
: December 1, 2009
Results First Posted
: June 10, 2016
Last Update Posted
: June 10, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Parkinson 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.
Study Type : | Observational |
Actual Enrollment : | 156 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | April 2015 |

Group/Cohort |
---|
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.
|
- Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 95 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022073
United States, California | |
UCLA-University of California at Los Angeles(904) | |
Los Angeles, California, United States, 90095 | |
San Francisco-University of California at San Francisco(905) | |
San Francisco, California, United States, 94115 | |
San Francisco VA Medical Center, San Francisco, CA | |
San Francisco, California, United States, 94121 | |
VA Greater Los Angeles Healthcare System, West LA | |
West Los Angeles, California, United States, 90073 | |
United States, Oregon | |
VA Medical Center, Portland | |
Portland, Oregon, United States, 97201 | |
Portland-Oregon Health & science University(906) | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
VA Medical Center, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Philadelphia-University of Pennsylvania Health System(901) | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Houston-Methodist Hospital(903) | |
Houston, Texas, United States, 77030 | |
Michael E. DeBakey VA Medical Center (152) | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 | |
Richmond-Medical college of Virginia(902) | |
Richmond, Virginia, United States, 23298 |
Study Chair: | William J. Marks, MD | San Francisco VA Medical Center, San Francisco, CA |
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01022073 History of Changes |
Other Study ID Numbers: |
468F |
First Posted: | December 1, 2009 Key Record Dates |
Results First Posted: | June 10, 2016 |
Last Update Posted: | June 10, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | We can share the data based on the VA approved Data Use Agreement(DUA) |
Keywords provided by VA Office of Research and Development:
Deep Brain Stimulation Subthalamic Nucleus Globus Pallidus Parkinson Disease |
Additional relevant MeSH terms:
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |