Deep Brain StimulationVISIONNCT05774041
Visualization of the STN and GPi for DBS
An observational study of Deep Brain Stimulation and Parkinson Disease, run by Surgical Information Sciences Inc. at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Brain Stimulation, Parkinson Disease
- What is being tested?
- SIS System
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- 19 Oct 2023to 7 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Duke University
Durham, North Carolina, 27705
Hartford Hospital
Hartford, Connecticut, 06106
Penn State University
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
University of Miami
Miami, Florida, 33136
Carilion Clinic
Roanoke, Virginia, 24014
University of South Florida
Tampa, Florida, 33606
University of Arizona
Tucson, Arizona, 85724
About this study
Official title: 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.
Read the 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.
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Being tested
- SIS System
- Keywords
- Subthalamic nucleus, Globus pallidus, DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| SIS Group | Standard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning Receives: Device: SIS System | |
| Control Group | Standard of care DBS surgery and preoperative target planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start19 Oct 2023
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Why it stopped: Study terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surgical Information Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774041
- Sponsor's protocol ID
- DOC-0039
- Acronym
- VISION
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05774041
- Acronym / sponsor ID
- VISION / DOC-0039
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Keywords
- Subthalamic nucleus, Globus pallidus, DBS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated by Sponsor
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Surgical Information Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIS Group | – | Device: SIS SystemStandard of care DBS surgery + use of (FDA-cleared) SIS System for preoperative target planning |
| Control Group | – | –Standard of care DBS surgery and preoperative target planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIS SystemFDA-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. | Device | SIS Group |
Primary outcome
Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate
Time frame: 1 day
Compare the mean distance between the DBS planned target location to the actual implanted lead location for the SIS Group and Control Group
Results and safety
The study was stopped early (reason given: Study terminated by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation and Parkinson Disease, run by Surgical Information Sciences Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated by Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.