Visualization of the STN and GPi for DBS

Terminated

• Conditions: Parkinson Disease; Deep Brain Stimulation
• Interventions: Device: SIS System

• Registration Number: NCT05774041
• Lead Sponsor: Surgical Information Sciences Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-07
• Study First Submitted QC: 2023-03-07
• Study First Posted: 2023-03-17
• Study Start: 2023-10-19
• Status Verified: 2025-04
• Primary Completion: 2025-04-07
• Study Completion: 2025-04-07
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate	1 day	Compare the mean distance between the DBS planned target location to the actual implanted lead location for the SIS Group and Control Group

Trial Locations

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

University of Miami; 🇺🇸 Miami, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Penn State University; 🇺🇸 Hershey, Pennsylvania, United States

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States