Visualization of the STN and GPi for DBS (VISION)

Surgical Information Sciences

Status

Terminated

Conditions

Parkinson Disease

Deep Brain Stimulation

Treatments

Device: SIS System

Study type

Observational

Funder types

Industry

Identifiers

NCT05774041

DOC-0039

Details and patient eligibility

About

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.

Full description

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.