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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01022073
First received: November 25, 2009
Last updated: May 4, 2016
Last verified: May 2016
  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 VA Office of Research and Development:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 156
Study Start Date: June 2010
Study Completion Date: April 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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   (Adult, Senior)
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

Locations
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
Sponsors and Collaborators
VA Office of Research and Development
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Study Chair: William J. Marks, MD San Francisco VA Medical Center, San Francisco, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01022073     History of Changes
Other Study ID Numbers: 468F 
Study First Received: November 25, 2009
Results First Received: March 31, 2016
Last Updated: May 4, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
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

ClinicalTrials.gov processed this record on December 02, 2016