NCT03907319

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 7, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

April 2, 2019

Last Update Submit

April 11, 2022

Conditions

Deep Brain Stimulation

Keywords

STNParkinson's DiseaseSubthalamic Nucleus

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Rate of Correlation of Predicted Outcome to Monopolar Review Outcome

    1 Month

  • Rate of Correlation of DBS Lead Location to Long Term Outcomes

    3-6 months

Interventions

SIS SystemDEVICE

Software technology for visualization of anatomical structures in the brain

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Idiopathic PD
  • Bilateral or unilateral STN-HFS for PD
  • % improvement response to medications preoperatively

You may not qualify if:

  • Missing required MR/CT imaging data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Noam Harel, PhD

    Surgical Information Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 8, 2019

Study Start

June 7, 2019

Primary Completion

September 30, 2020

Study Completion

April 11, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)