Validation of a Seizure Monitoring System

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Medtronic LINQ Device

Device

Using two LINQ devices that are fixed to scalp to record EEG (in addition to the standard scalp EEG).

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

St Vincent's Hospital Melbourne

Other

Collaborators

Seer Medical
University of Melbourne

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Mar 14, 2018
Registry last updated: Oct 27, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed