Visualization of the STN and GPi for DBS

Surgical Information Sciences Inc.80 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Deep Brain Stimulation Parkinson Disease

Interventions

SIS SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

University of Arizona

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Hartford Hospital

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

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

Time frame: 1 day

Data from ClinicalTrials.gov

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