NCT05774041

Brief Summary

The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

10 active sites

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

March 7, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

March 7, 2023

Last Update Submit

April 22, 2025

Conditions

Deep Brain StimulationParkinson Disease

Keywords

Subthalamic nucleusGlobus pallidusDBS

Outcome Measures

Primary Outcomes (1)

  • Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate

    Compare the mean distance between the DBS planned target location to the actual implanted lead location for the SIS Group and Control Group

    1 day

Other Outcomes (6)

  • Proportion of patients(%) with procedure-related adverse events, average duration of DBS surgery (hours:minutes), and percentage of cases in which intra-operative testing was performed

    1 month

  • Compare width of the therapeutic window (the electrical current at which a sustained side effect occurs minus the electrical current at which a meaningful therapeutic benefit was observed)

    6 months

  • Change in average levodopa equivalent daily dosage (mg)

    6 months

  • +3 more other outcomes

Study Arms (2)

SIS Group

Standard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning

Device: SIS System

Control Group

Standard of care DBS surgery and preoperative target planning

Interventions

SIS SystemDEVICE

FDA-cleared software that enhances standard clinical images for the visualization of structures in the basal ganglia area of the brain which are commonly targeted for DBS lead placement.

SIS Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic Parkinson's Disease indicated for de novo bilateral DBS surgery implant in the STN or GPi will be considered for study participation.

You may qualify if:

  • Subject is diagnosed with Idiopathic Parkinson's Disease and is indicated for de novo DBS surgery with bilateral DBS leads implanted in the STN or GPi.
  • Subject is 18 years or older.
  • Subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures.

You may not qualify if:

  • Subject is not a DBS surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate DBS surgery.
  • Subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps.
  • Subject's life expectancy is less than one year.
  • Subject is Hoehn and Yahr stage 4-5 in the medication OFF condition.
  • Subject is pregnant or interested in becoming pregnant during the duration of the study.
  • Subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Penn State University

Hershey, Pennsylvania, 17033, United States

Location

Carilion Clinic

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 17, 2023

Study Start

October 19, 2023

Primary Completion

April 7, 2025

Study Completion

April 7, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(10)