Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation

NCT ID: NCT01022073

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-04-30

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William J. Marks, MD

Role: STUDY_CHAIR

San Francisco VA Medical Center, San Francisco, CA

Locations

UCLA-University of California at Los Angeles(904)

Los Angeles, California, United States

San Francisco-University of California at San Francisco(905)

San Francisco, California, United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, United States

VA Medical Center, Portland

Portland, Oregon, United States

Portland-Oregon Health & science University(906)

Portland, Oregon, United States

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, United States

Philadelphia-University of Pennsylvania Health System(901)

Philadelphia, Pennsylvania, United States

Houston-Methodist Hospital(903)

Houston, Texas, United States

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, United States

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Richmond-Medical college of Virginia(902)

Richmond, Virginia, United States

Countries

United States

Other Identifiers

468F

Identifier Type: -

Identifier Source: org_study_id