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OpenTrials
Completed

NCT Number: NCT03363724

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deep Brain Stimulation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

HaGuide version 1.0 software module

Other

Primary outcomes

  1. HaGuide vs. Neurosurgeon measurements

    Time frame: 2 weeks

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

Secondary outcomes

  1. DLOR vs. VMNR

    Time frame: 2 weeks

    Length (mm) of Dorso-Lateral Oscillatory Region (DLOR) vs. Ventro-Medial Non-Oscillatory Region (VMNR);

  2. DLOR Entry/exit

    Time frame: 2 weeks

    Entry/exit from DLOR (depth in mm)

  3. STN Length

    Time frame: 2 weeks

    Length of STN track (mm

  4. DBS implant optimal track Identification

    Time frame: 2 weeks

    Percent agreement in DBS implant optimal track Identification by percent agreement between HaGuide and Neurosurgeon choice of optimal track for DBS implant

  5. Sites/Users comparison

    Time frame: 2 weeks

    Sub-group analysis to determine the variation between sites by percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements

Sponsors and collaborators

Lead sponsor

Alpha Omega Engineering Ltd.

Industry

Collaborators

  • Hadassah Medical Organization
  • Swedish Medical Center
  • University of Colorado, Denver

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2017
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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