Visualization of the STN and GPi for DBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-19

Study Completion Date

2025-04-07

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.

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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.

Conditions

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Deep Brain Stimulation Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SIS Group

Standard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning

SIS System

Intervention Type DEVICE

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.

Control Group

Standard of care DBS surgery and preoperative target planning

No interventions assigned to this group

Interventions

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SIS System

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.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No