ECV - Epihunter Clinical Validation

Epihunter NV4 sites in 4 countries102 target enrollmentMay 1, 2020

ConditionsAbsence Seizures Absence Epilepsy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Absence Seizures
Sponsor: Epihunter NV
Enrollment: 102
Locations: 4
Primary Endpoint: Sensitivity for electrographic seizures of study device compared to video EEG
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.

Registry

clinicaltrials.gov

Start Date

May 1, 2020

End Date

December 31, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Epihunter NV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects should have an indication of having absence seizures
•Subjects should be admitted for video EEG monitoring as part of their clinical practice
•Age \> 4 years

Exclusion Criteria

•Head circumference should be compatible for wearable EEG device (40-70cm)
•The subject should be able to understand instructions and refrain from removing the device from its head

Outcomes

Primary Outcomes

Sensitivity for electrographic seizures of study device compared to video EEG

Time Frame: 9 months

The sensitivity for electrographic seizures by the study device compared to manually annotated electrographic seizures on non-video EEG is \> 0.90 (median sensitivity per patient)

Number of false alarms by study device per hour

Time Frame: 9 months

The number of false alarms by the study device \< 0.1 per hour (median false detection rate per recording)