Visualization of the STN and GPi for DBS

Study Overview
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Brief Summary
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The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

Detailed Description
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This is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System. The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System. Parkinson's Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated. Subjects will be followed through six months after initial DBS programming to collect clinical outcomes.

Official Title
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Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease

Conditions
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Deep Brain Stimulation, Parkinson Disease

Intervention / Treatment
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* Device: SIS System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is diagnosed with Idiopathic Parkinson's Disease and is indicated for de novo DBS surgery with bilateral DBS leads implanted in the STN or GPi. Subject is 18 years or older. Subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures. Exclusion Criteria: Subject is not a DBS surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate DBS surgery. Subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps. Subject's life expectancy is less than one year. Subject is Hoehn and Yahr stage 4-5 in the medication OFF condition. Subject is pregnant or interested in becoming pregnant during the duration of the study. Subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| SIS Group<br>Standard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning | Device: SIS System<br>* FDA-cleared software that enhances standard clinical images for the visualization of structures in the basal ganglia area of the brain which are commonly targeted for DBS lead placement.<br>|
| Control Group<br>Standard of care DBS surgery and preoperative target planning | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate | Compare the mean distance between the DBS planned target location to the actual implanted lead location for the SIS Group and Control Group | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DBS, Subthalamic nucleus, Globus pallidus