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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363724
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
University of Colorado, Denver
Hadassah Medical Organization
Swedish Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Parkinson Disease Deep Brain Stimulation Other: HaGuide version 1.0 software module

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. HaGuide vs. Neurosurgeon measurements [ Time Frame: 2 weeks ]
    Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363724


Sponsors and Collaborators
Alpha Omega Engineering Ltd.
University of Colorado, Denver
Hadassah Medical Organization
Swedish Medical Center
Investigators
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Principal Investigator: John A Thompson, Dr. University of Colorado, Denver
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Responsible Party: Alpha Omega Engineering Ltd.
ClinicalTrials.gov Identifier: NCT03363724    
Other Study ID Numbers: AO-001
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alpha Omega Engineering Ltd.:
Parkinson Disease
Deep Brain Stimulation
Microelectrodes recording
HaGuide
Alpha Omega Engineering Ltd.
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases