Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure

Alpha Omega Engineering

Status: Completed

Conditions: Parkinson Disease; Deep Brain Stimulation

Treatments: Other: HaGuide version 1.0 software module

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03363724

AO-001

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient was diagnosed with Parkinson's disease;
2. Patient underwent implantation of DBS electrode in the STN for the treatment of Parkinson's disease, using the Neuro-Omega device for navigation;
3. Procedure's MER digital recorded data is available;

Exclusion criteria

1. DBS performed for any other movement disorder other than Parkinson's Disease including Parkinsonism;
2. 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;
3. Missing data for primary end-point on the respective patient medical chart;
4. The collected data that is used for the validation is with high step size resolution;

Trial design

103 participants in 1 patient group

HaGuide version 1.0 software module

Description:

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.

Treatment:

Other: HaGuide version 1.0 software module