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

NCT ID: NCT03363724

Last Updated: 2017-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Deep Brain Stimulation

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

HaGuide version 1.0 software module

Intervention Type OTHER

Interventions

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HaGuide version 1.0 software module

Intervention Type OTHER

Eligibility Criteria

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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;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role collaborator

Swedish Medical Center

OTHER

Sponsor Role collaborator

Alpha Omega Engineering Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John A Thompson, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

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AO-001

Identifier Type: -

Identifier Source: org_study_id