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

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 Overview

• Status: Completed
• Conditions: Parkinson Disease; Deep Brain Stimulation
• Intervention / Treatment: Other: HaGuide version 1.0 software module

• Study Type: Observational
• Enrollment (Actual): 103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: HaGuide version 1.0 software module

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLOR vs. VMNR	Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR);	2 weeks
DLOR Entry/exit	Entry/exit from DLOR (depth in mm)	2 weeks
STN Length	Length of STN track (mm	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	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	2 weeks

Collaborators and Investigators

• Sponsor: Alpha Omega Engineering Ltd.
• Collaborators: University of Colorado, Denver; Hadassah Medical Organization; Swedish Medical Center
• Investigators: Principal Investigator: John A Thompson, Dr., University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): March 30, 2017
• Study Completion (ACTUAL): March 30, 2017

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson Disease; Deep Brain Stimulation; Microelectrodes recording; HaGuide; Alpha Omega Engineering Ltd.
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: AO-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No