Deep Brain Stimulation
Conditions
Keywords
STN, Parkinson's Disease, Subthalamic Nucleus
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.
Interventions
DEVICESIS System
Software technology for visualization of anatomical structures in the brain
Sponsors
Surgical Information Sciences Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Idiopathic PD * Bilateral or unilateral STN-HFS for PD * 40% improvement response to medications preoperatively Key
Exclusion criteria
* Missing required MR/CT imaging data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed