Visualization of the STN and GPi for DBS
Purpose
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.
Conditions
- Deep Brain Stimulation
- Parkinson Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| SIS Group | Standard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning |
|
| Control Group | Standard of care DBS surgery and preoperative target planning |
|
Recruiting Locations
Little Rock, Arkansas 72205
Tampa, Florida 33606
Iowa City, Iowa 52242
Boston, Massachusetts 02215
Hershey, Pennsylvania 17033
More Details
- NCT ID
- NCT05774041
- Status
- Recruiting
- Sponsor
- Surgical Information Sciences Inc.
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.