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Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 19, 2023
Primary Completion Date
April 7, 2025
Completion Date
April 7, 2025
Last Updated
April 25, 2025
80
ACTUAL participants
SIS System
DEVICE
Lead Sponsor
Surgical Information Sciences Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06113640