Visualization of the STN and GPi for DBS

Parkinson Disease Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05774041
• Other study ID #: DOC-0039
• Status: Recruiting
• Start date: October 19, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Surgical Information Sciences Inc.
• Contact: Lisa Ingham
• Phone: 612-242-2226
• Email: lisa.ingham[@]surgicalis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State University	Hershey	Pennsylvania
United States	University of Iowa	Iowa City	Iowa
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of Miami	Miami	Florida
United States	Carilion Clinic	Roanoke	Virginia
United States	University of South Florida	Tampa	Florida
United States	University of Arizona	Tucson	Arizona

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
Other	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
Other	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
Other	Change in average levodopa equivalent daily dosage (mg)	Compare change in mean levodopa equivalent daily dose for SIS and Control groups	6 months
Other	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
Other	Rate (%) of stimulation-related side effects	Compare the rate of stimulation related side effects in SIS and Control groups	6 months
Other	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
Primary	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