Deep Brain StimulationSTNNCT03907319
SIS Evaluation of the MRI Defined Subthalamic Nucleus*
An observational study of Deep Brain Stimulation, run by Surgical Information Sciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Deep Brain Stimulation
- What is being tested?
- SIS System
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 11 Apr 2022
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Idiopathic PD
- Bilateral or unilateral STN-HFS for PD
- 40% improvement response to medications preoperatively
Who cannot join
- Missing required MR/CT imaging data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Multi-Site Re-Evaluation of the MRI Defined STN and Its Correlation to Motor Outcomes With Stimulation Treatment
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.
Read the detailed description
The purpose of this study is to collect retrospective data to demonstrate the ability of the SIS system to visualize the MRI-defined STN in patients with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) procedure targeting the STN.
- Conditions
- Deep Brain Stimulation
- Being tested
- SIS System
- Keywords
- STN, Parkinson's Disease, Subthalamic Nucleus
- 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
Software technology for visualization of anatomical structures in the brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of STN Visualization Success
Measure the proportion of images successfully processed for visualization of the STN over total number of image sets
Measured: 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
Measured: Day 1
Secondary outcomes (2)
Rate of Correlation of Predicted Outcome to Monopolar Review Outcome
Rate of blinded predicted outcome compared to monopolar review outcomes
Measured: 1 Month
Rate of Correlation of DBS Lead Location to Long Term Outcomes
Rate of agreement between SIS-defined model of STN and actual DBS lead location and clinical motor outcomes
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start7 Jun 2019
- Primary completion30 Sep 2020
- Study completion11 Apr 2022
Why it stopped: Enrollment not sufficient for data analysis.
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
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Surgical Information Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noam Harel, PhD, Principal investigator, Surgical Information Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907319
- Sponsor's protocol ID
- SIS DOC-0013
- Acronym
- STN
- Status last verified
- Apr 2022
- First submitted
- 2 Apr 2019
- Last updated
- 19 Apr 2022
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multi-Site Re-Evaluation of the MRI Defined STN and Its Correlation to Motor Outcomes With Stimulation Treatment
- ClinicalTrials.gov ID
- NCT03907319
- Acronym / sponsor ID
- STN / SIS DOC-0013
- Conditions
- Deep Brain Stimulation
- Keywords
- STN, Parkinson's Disease, Subthalamic Nucleus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment not sufficient for data analysis.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Surgical Information Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 8 Apr 2019 (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.
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.
Detailed description
The purpose of this study is to collect retrospective data to demonstrate the ability of the SIS system to visualize the MRI-defined STN in patients with Parkinson's Disease (PD) who have undergone deep brain stimulation (DBS) procedure targeting the STN.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Idiopathic PD
- Bilateral or unilateral STN-HFS for PD
- 40% improvement response to medications preoperatively
Key exclusion criteria (1 listed)
- Missing required MR/CT imaging data
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 SystemSoftware technology for visualization of anatomical structures in the brain | Device | – |
Primary outcome
Percent of STN Visualization Success
Time frame: Day 1
Measure the proportion of images successfully processed for visualization of the STN over total number of image sets
Incidence of DBS Lead Location in Proximity to STN
Time frame: Day 1
Determine incidence in which the location of the DBS lead is in or outside the STN
2 secondary outcomes
Rate of Correlation of Predicted Outcome to Monopolar Review Outcome
Time frame: 1 Month
Rate of Correlation of DBS Lead Location to Long Term Outcomes
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: Enrollment not sufficient for data analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- 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.
Noam Harel, PhD principal investigator
Surgical Information Sciences
1 site 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, run by Surgical Information Sciences Inc. at 1 site 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 1 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 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Enrollment not sufficient for data analysis.). 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?
Percent of STN Visualization Success (time frame: Day 1). The study lists 2 primary outcomes in all. 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 19 Apr 2022.