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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03363724

Enrollment

103

Registered

2017-12-06

Start date

2016-12-31

Completion date

2017-03-30

Last updated

2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Brain Stimulation, Parkinson Disease

Keywords

Parkinson Disease, Deep Brain Stimulation, Microelectrodes recording, HaGuide, Alpha Omega Engineering Ltd.

Brief 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. 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.

Interventions

OTHERHaGuide version 1.0 software module

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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;

Design outcomes

Primary

Measure	Time frame	Description
HaGuide vs. Neurosurgeon measurements	2 weeks	Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements

Secondary

Measure	Time frame	Description
DLOR vs. VMNR	2 weeks	Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR);
DLOR Entry/exit	2 weeks	Entry/exit from DLOR (depth in mm)
STN Length	2 weeks	Length of STN track (mm
DBS implant optimal track Identification	2 weeks	Percent agreement in DBS implant optimal track Identification by percent agreement between HaGuide and Neurosurgeon choice of optimal track for DBS implant
Sites/Users comparison	2 weeks	Sub-group analysis to determine the variation between sites by percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026