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

NCT03363724 | Completed

• 1 other identifier: AO-001
• Study Type: observational
• Target: 103
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease; Deep Brain Stimulation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HaGuide vs. Neurosurgeon measurements

  Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements

  2 weeks

Secondary Outcomes (5)

• DLOR vs. VMNR

  2 weeks

• DLOR Entry/exit

  2 weeks

• STN Length

  2 weeks

• DBS implant optimal track Identification

  2 weeks

• Sites/Users comparison

  2 weeks

Study Arms (1)

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

Interventions

HaGuide version 1.0 software module OTHER

HaGuide version 1.0 software module

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alpha Omega Engineering Ltd.: lead
• University of Colorado, Denver: collaborator
• Hadassah Medical Organization: collaborator
• Swedish Medical Center: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• John A Thompson, Dr.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2017
• First Posted: December 6, 2017
• Study Start: December 1, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: December 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share