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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Globus Pallidus interna Group<br>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<br>Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) | 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. | The change score of UPDRS Part III from baseline to 9 years post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, Subthalamic Nucleus, Globus Pallidus, Parkinson Disease