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
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