Visualization of the STN and GPi for DBS (VISION)

Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease; Deep Brain Stimulation
• Intervention / Treatment: Device: SIS System

Detailed Description

This is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System. 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.

Parkinson's Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated. Subjects will be followed through six months after initial DBS programming to collect clinical outcomes.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SIS Group; Standard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning	Device: SIS System; 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.
Control Group; Standard of care DBS surgery and preoperative target planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Compare surgical characteristics, such as rate of procedure-related adverse events, mean surgical time, and use of intra-operative testing for SIS and Control groups	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)	Compare DBS programming settings, such as therapeutic window of SIS and Control groups	6 months
Change in average levodopa equivalent daily dosage (mg)	Compare change in mean levodopa equivalent daily dose for SIS and Control groups	6 months
Change in mean score of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III	Compare changes in mean MDS-UPDRS Part III motor improvement for SIS and Control groups. MDS-UPDRS Part III is a validated questionnaire to assess the severity of motor symptoms in patients with Parkinson's disease. The motor examination consists of 33 scored movements. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score is obtained from the sum of the corresponding item scores.	6 months
Rate (%) of stimulation-related side effects	Compare the rate of stimulation related side effects in SIS and Control groups	6 months
Compare percentage of motor benefit from MDS-UPDRS Part III to implanted lead location	Measure hemi-body motor improvement and compare percentage of improvement to the implanted DBS lead location	6 months

Collaborators and Investigators

• Sponsor: Surgical Information Sciences Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Actual): April 7, 2025
• Study Completion (Actual): April 7, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Subthalamic nucleus; DBS; Globus pallidus
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: DOC-0039

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