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Validation of a Seizure Monitoring System

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: NCT03465189
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
University of Melbourne
Seer Medical
Information provided by (Responsible Party):
Mark Cook, St Vincent's Hospital Melbourne

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Epilepsy Device: Medtronic LINQ Device

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Seizure Monitoring System
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : March 19, 2019
Actual Study Completion Date : March 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Groups and Cohorts
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Intervention Details:
  • Device: Medtronic LINQ Device
    Using two LINQ devices that are fixed to scalp to record EEG (in addition to the standard scalp EEG).

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with epilepsy
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03465189


Locations
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Australia, Victoria
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
St Vincent's Hospital Melbourne
University of Melbourne
Seer Medical
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mark Cook, Principal Investigator, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier: NCT03465189    
Other Study ID Numbers: HREC/18/SVHM/50
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
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: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations