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

VA Office of Research and Development

Status: Completed

Conditions: Parkinson Disease

Study type: Observational

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT01022073

468F

Details and patient eligibility

About

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

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 21 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

156 participants in 2 patient groups

Globus Pallidus interna Group

Description:

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

Description:

Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.