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NCT03465189 Clinical Trial

Validation of a Seizure Monitoring System

Epilepsy Clinical Trial

Official title:
Validation of a Seizure Monitoring System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03465189
Other study ID # HREC/18/SVHM/50
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2018
Est. completion date March 19, 2020

Study information
Verified date October 2020
Source St Vincent's Hospital Melbourne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 19, 2020
Est. primary completion date March 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Australia St Vincent's Hospital Melbourne Melbourne Victoria

Sponsors (3)
Lead Sponsor Collaborator
St Vincent's Hospital Melbourne Seer Medical, University of Melbourne

Country where clinical trial is conducted

Australia, 

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