Trial record 8 of 122 for:    Parkinson's disease AND NINDS

Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation (CSP#468F)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01022073
First received: November 25, 2009
Last updated: June 17, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 explanation 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
Study Population

Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022073

Contacts
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

Locations
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   
Sponsors and Collaborators
Investigators
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: June 17, 2014
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 August 19, 2014