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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

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