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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Deep Brain Stimulation

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