SIS Evaluation of the MRI Defined Subthalamic Nucleus* (STN)

April 11, 2022 updated by: Surgical Information Sciences Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who have completed bilateral or unilateral high frequency stimulation of the subthalamic nucleus (STN-HFS) for idiopathic PD and have pre and post operative MR and CT imaging, programming data, Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) scores and a 3-6 month follow-up evaluation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of STN Visualization Success
Time Frame: Day 1
Measure the proportion of images successfully processed for visualization of the STN over total number of image sets
Day 1
Incidence of DBS Lead Location in Proximity to STN
Time Frame: Day 1
Determine incidence in which the location of the DBS lead is in or outside the STN
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Correlation of Predicted Outcome to Monopolar Review Outcome
Time Frame: 1 Month
Rate of blinded predicted outcome compared to monopolar review outcomes
1 Month
Rate of Correlation of DBS Lead Location to Long Term Outcomes
Time Frame: 3-6 months
Rate of agreement between SIS-defined model of STN and actual DBS lead location and clinical motor outcomes
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Surgical Information Sciences Inc.

Investigators

  • Principal Investigator: Noam Harel, PhD, Surgical Information Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2019

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

April 11, 2022

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (ACTUAL)

April 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIS DOC-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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