Parkinson DiseaseNCT03363724
Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure
An observational study of Parkinson Disease and Deep Brain Stimulation, run by Alpha Omega Engineering Ltd..
Trial summary
HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mapping visually the depth of STN landmarks intra-operatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation
- What is being tested?
- HaGuide version 1.0 software module
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 30 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with Parkinson's Disease who underwent implantation of DBS electrode in the STN for the treatment of Parkinson's Disease, using the Neuro-Omega device for navigation and procedure's MER digital recorded data is available.
Who may be able to join
- Patient was diagnosed with Parkinson's disease;
- Patient underwent implantation of DBS electrode in the STN for the treatment of Parkinson's disease, using the Neuro-Omega device for navigation;
- Procedure's MER digital recorded data is available;
Who cannot join
- DBS performed for any other movement disorder other than Parkinson's Disease including Parkinsonism;
- The recording has a high intensity of noise that will not allow re-analysis using the HaGuide software, in such cases the HaGuide software indicates that the signal is not valid for analysis;
- Missing data for primary end-point on the respective patient medical chart;
- The collected data that is used for the validation is with high step size resolution;
About this study
Official title: A Retrospective, Multi-Center, Clinical Validation of HaGuide Software Module Accuracy in Mapping Sub-thalamic Nucleus (STN) Boundaries in Parkinson's Disease Patients Who Underwent Deep Brain Stimulation (DBS) Procedure
HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mapping visually the depth of STN landmarks intra-operatively. HaGuide algorithm computes and displays the STN entry and exit, as well as introduces a detection of a distinct DLOR-VMNR boundary. HaGuide visual display is added to the UI and it is supplementing and not replacing the previously cleared standard display (visual and audio) of the system.
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Being tested
- HaGuide version 1.0 software module
- Keywords
- Parkinson Disease, Deep Brain Stimulation, Microelectrodes recording, HaGuide, Alpha Omega Engineering Ltd.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaGuide version 1.0 software moduleOther
| Study group | Role | What they receive |
|---|---|---|
| HaGuide version 1.0 software module | Patients diagnosed with Parkinson's Disease who underwent implantation of DBS electrode in the STN for the treatment of Parkinson's Disease, using the Neuro-Omega device for navigation and procedure's MER digital recorded data is available. Receives: Other: HaGuide version 1.0 software module |
What is being measured
The primary outcome is the main question the study is designed to answer.
HaGuide vs. Neurosurgeon measurements
Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements
Measured: 2 weeks
Secondary outcomes (5)
DLOR vs. VMNR
Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR);
Measured: 2 weeks
DLOR Entry/exit
Entry/exit from DLOR (depth in mm)
Measured: 2 weeks
STN Length
Length of STN track (mm
Measured: 2 weeks
DBS implant optimal track Identification
Percent agreement in DBS implant optimal track Identification by percent agreement between HaGuide and Neurosurgeon choice of optimal track for DBS implant
Measured: 2 weeks
Sites/Users comparison
Sub-group analysis to determine the variation between sites by percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startDec 2016
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpha Omega Engineering Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Denver, Hadassah Medical Organization, Swedish Medical Center
- Responsible party
- Sponsor
- Investigators
- John A Thompson, Dr., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363724
- Sponsor's protocol ID
- AO-001
- Status last verified
- Nov 2017
- First submitted
- 19 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multi-Center, Clinical Validation of HaGuide Software Module Accuracy in Mapping Sub-thalamic Nucleus (STN) Boundaries in Parkinson's Disease Patients Who Underwent Deep Brain Stimulation (DBS) Procedure
- ClinicalTrials.gov ID
- NCT03363724
- Acronym / sponsor ID
- AO-001
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Keywords
- Parkinson Disease, Deep Brain Stimulation, Microelectrodes recording, HaGuide, Alpha Omega Engineering Ltd.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Alpha Omega Engineering Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Denver, Hadassah Medical Organization, Swedish Medical Center
- Study start
- Dec 2016 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 6 Dec 2017 (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.
HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mapping visually the depth of STN landmarks intra-operatively. HaGuide algorithm computes and displays the STN entry and exit, as well as introduces a detection of a distinct DLOR-VMNR boundary. HaGuide visual display is added to the UI and it is supplementing and not replacing the previously cleared standard display (visual and audio) of the system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HaGuide version 1.0 software module | – | Other: HaGuide version 1.0 software modulePatients diagnosed with Parkinson's Disease who underwent implantation of DBS electrode in the STN for the treatment of Parkinson's Disease, using the Neuro-Omega device for navigation and procedure's MER digital recorded data is available. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Parkinson's Disease who underwent implantation of DBS electrode in the STN for the treatment of Parkinson's Disease, using the Neuro-Omega device for navigation and procedure's MER digital recorded data is available.
Key inclusion criteria (3 listed)
- Patient was diagnosed with Parkinson's disease;
- Patient underwent implantation of DBS electrode in the STN for the treatment of Parkinson's disease, using the Neuro-Omega device for navigation;
- Procedure's MER digital recorded data is available;
Key exclusion criteria (4 listed)
- DBS performed for any other movement disorder other than Parkinson's Disease including Parkinsonism;
- The recording has a high intensity of noise that will not allow re-analysis using the HaGuide software, in such cases the HaGuide software indicates that the signal is not valid for analysis;
- Missing data for primary end-point on the respective patient medical chart;
- The collected data that is used for the validation is with high step size resolution;
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 |
|---|---|---|
| HaGuide version 1.0 software module | Other | HaGuide version 1.0 software module |
Primary outcome
HaGuide vs. Neurosurgeon measurements
Time frame: 2 weeks
Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements
5 secondary outcomes
DLOR vs. VMNR
Time frame: 2 weeks
DLOR Entry/exit
Time frame: 2 weeks
STN Length
Time frame: 2 weeks
DBS implant optimal track Identification
Time frame: 2 weeks
Sites/Users comparison
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- 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.
John A Thompson, Dr. principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Deep Brain Stimulation, run by Alpha Omega Engineering Ltd..
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 4 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: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HaGuide vs. Neurosurgeon measurements (time frame: 2 weeks). 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 6 Dec 2017.