Visualization of the STN and GPi for DBS
Stopped early
Conditions studied: Deep Brain Stimulation, Parkinson Disease
In brief
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.
Key facts
- Study ID
- NCT05774041
- Run by
- Surgical Information Sciences Inc.
- People needed
- 80
- Starts
- 2023-10-19
- Expected to finish
- 2025-04-07
- Last updated by the study team
- 2025-04-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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