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NCT03907319 Clinical Trial

SIS Evaluation of the MRI Defined Subthalamic Nucleus*

Deep Brain Stimulation Clinical Trial

— STN  

Official title:
Retrospective Multi-Site Re-Evaluation of the MRI Defined STN and Its Correlation to Motor Outcomes With Stimulation Treatment

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03907319
Other study ID # SIS DOC-0013
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 7, 2019
Est. completion date April 11, 2022

Study information
Verified date April 2022
Source Surgical Information Sciences Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 15
Est. completion date April 11, 2022
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SIS System
Software technology for visualization of anatomical structures in the brain

Locations
Country Name City State
United States UPMC Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Surgical Information Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of STN Visualization Success Measure the proportion of images successfully processed for visualization of the STN over total number of image sets Day 1
Primary Incidence of DBS Lead Location in Proximity to STN Determine incidence in which the location of the DBS lead is in or outside the STN Day 1
Secondary Rate of Correlation of Predicted Outcome to Monopolar Review Outcome Rate of blinded predicted outcome compared to monopolar review outcomes 1 Month
Secondary Rate of Correlation of DBS Lead Location to Long Term Outcomes Rate of agreement between SIS-defined model of STN and actual DBS lead location and clinical motor outcomes 3-6 months
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