Clinical trial NCT01022073: Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Subthalamic Nucleus
Globus Pallidus
Parkinson Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2009-12-01
Enrollment: 156
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's Disease who were enrolled in CSP 468, and received DBS.

Brief summary: Follow up of patients enrolled in CSP 468, a study of deep brain stimulation treatment for Parkinson's disease

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 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.

Primary outcomes:
measure: Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)
timeFrame: The change score of UPDRS Part III from baseline to 9 years post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA-University of California at Los Angeles(904)
state: California
city: San Francisco
country: United States
facility: San Francisco-University of California at San Francisco(905)
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Portland
country: United States
facility: Portland-Oregon Health & science University(906)
state: Oregon
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia-University of Pennsylvania Health System(901)
state: Pennsylvania
city: Houston
country: United States
facility: Houston-Methodist Hospital(903)
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (152)
state: Texas
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Richmond-Medical college of Virginia(902)
state: Virginia
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: William J. Marks, MD
role: STUDY_CHAIR
References: