NCT05774041

Visualization of the STN and GPi for DBS

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Surgical Information Sciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Deep Brain Stimulation
• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-10-19
• Primary completion: 2025-04-07
• Completion: 2025-04-07
• First posted: 2023-03-17
• Last updated: 2025-04-25

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study