Validation of a Seizure Monitoring System

October 25, 2020 updated by: Mark Cook, St Vincent's Hospital Melbourne
The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with epilepsy

Description

Inclusion Criteria:

  • Patients with epilepsy

Exclusion Criteria:

  • Women that are pregnant
  • Patients that are highly dependant on medical care
  • Patients that cannot give informed consent for themselves

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management
Time Frame: one week
Compare EEG from traditional scalp EEG to the LINQ recordings to determine if seizure activity can be accurately identified
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Vincent's Hospital Melbourne

Collaborators

University of Melbourne
Seer Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 10, 2018

Primary Completion (ACTUAL)

March 19, 2019

Study Completion (ACTUAL)

March 19, 2020

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (ACTUAL)

March 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 25, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/18/SVHM/50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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