SIS Evaluation of the MRI Defined Subthalamic Nucleus*
- Conditions
- Deep Brain Stimulation
- Registration Number
- NCT03907319
- Lead Sponsor
- Surgical Information Sciences Inc.
- Brief Summary
Retrospective review of images used to target the STN during DBS procedure and ability of the Surgical Information Sciences ("SIS") system to visualize the STN location.
- Detailed Description
The purpose of this study is to collect retrospective data to demonstrate the ability of the SIS system to visualize the MRI-defined STN in patients with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) procedure targeting the STN.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- Idiopathic PD
- Bilateral or unilateral STN-HFS for PD
- 40% improvement response to medications preoperatively
Key
- Missing required MR/CT imaging data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of DBS Lead Location in Proximity to STN Day 1 Determine incidence in which the location of the DBS lead is in or outside the STN
Percent of STN Visualization Success Day 1 Measure the proportion of images successfully processed for visualization of the STN over total number of image sets
- Secondary Outcome Measures
Name Time Method Rate of Correlation of Predicted Outcome to Monopolar Review Outcome 1 Month Rate of blinded predicted outcome compared to monopolar review outcomes
Rate of Correlation of DBS Lead Location to Long Term Outcomes 3-6 months Rate of agreement between SIS-defined model of STN and actual DBS lead location and clinical motor outcomes
Trial Locations
- Locations (1)
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States