Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation (CSP#468F)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease
| Condition |
|---|
|
Parkinson Disease |
| Study Type: | Observational |
| Study Design: | 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 |
- Off-medication/on-stimulation Motor Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) [ Time Frame: 7-13 years post implant ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 261 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1
Cohort of subjects who received DBS as part of the CSP 468 intervention trial, and still have their device working and in place.
|
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 explantation rate, neurostimulator replacement frequency, and changes in stimulation parameters to achieve optimum symptom control.
Eligibility| Ages Eligible for Study: | 21 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.
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.
Contacts and Locations| Contact: Elaine Lanier, MS | (415) 221-4810 ext 6488 | Elaine.Lanier@va.gov |
| Contact: Susan L Heath, RN | (415) 221-4810 ext 2505 | Susan.Heath@va.gov |
| United States, California | |
| UCLA-University of California at Los Angeles(904) | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jeff M Bronstein, MD 310-206-9799 jbronste@ucla.edu | |
| VA Medical Center, San Francisco | Recruiting |
| San Francisco, California, United States, 94121 | |
| Contact: William J Marks, MD 415-750-2100 william.marks@va.gov | |
| Contact: Nicholas B Galifianakis, MD (415) 221-4810 ext 3993 Nicholas.Galifianakis@va.gov | |
| Study Chair: William J. Marks, MD | |
| San Francisco-University of California at San Francisco(905) | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Jill L Ostrem, MD 415-353-7382 Jill.Ostrem@ucsf.edu | |
| VA Greater Los Angeles Healthcare System, West LA | Recruiting |
| West Los Angeles, California, United States, 90073 | |
| Contact: Jeff M Bronstein, MD 310-206-9766 jbronste@ucla.edu | |
| United States, Oregon | |
| VA Medical Center, Portland | Recruiting |
| Portland, Oregon, United States, 97201 | |
| Contact: Kathryn Chung, MD 503-721-2961 Kathryn.Chung@va.gov | |
| Portland-Oregon Health & science University(906) | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Matthew A Brodsky, MD 503-494-9059 BrodskyM@ohsu.edu | |
| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: John E Duda, MD 215-823-5934 john.duda@va.gov | |
| Philadelphia-University of Pennsylvania Health System(901) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Stacy Horn, DO 215-829-7512 shorn@pahosp.com | |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center (152) | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Aliya Sarwar, MD 713-794-7481 Aliya.Sarwar@va.gov | |
| Houston-Methodist Hospital(903) | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Eugene C Lai, MD 713-441-4449 eclai@tmhs.org | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | Recruiting |
| Richmond, Virginia, United States, 23249 | |
| Contact: Kathryn Holloway, MD 804-675-5931 Kathryn.holloway@va.gov | |
| Richmond-Medical college of Virginia(902) | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Kathryn Holloway, MD 804-828-2456 Kathryn.holloway@va.gov | |
| Study Chair: | William J. Marks, MD | VA Medical Center, San Francisco |
More Information
Additional Information:
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01022073 History of Changes |
| Other Study ID Numbers: | 468F |
| Study First Received: | November 25, 2009 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013