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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363724
• Other study ID #: AO-001
• Status: Completed
• Phase: N/A
• First received: November 19, 2017
• Last updated: November 30, 2017
• Start date: December 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: November 2017
• Source: Alpha Omega Engineering Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease

Intervention

Other:
• HaGuide version 1.0 software module

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Alpha Omega Engineering Ltd.	Hadassah Medical Organization, Swedish Medical Center, University of Colorado, Aurora

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HaGuide vs. Neurosurgeon measurements	Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements	2 weeks
Secondary	DLOR vs. VMNR	Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR);	2 weeks
Secondary	DLOR Entry/exit	Entry/exit from DLOR (depth in mm)	2 weeks
Secondary	STN Length	Length of STN track (mm	2 weeks
Secondary	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
Secondary	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