ECV - Epihunter Clinical Validation

Not Applicable

Completed

• Conditions: Absence Epilepsy; Absence Seizures
• Interventions: Device: Epihunter

• Registration Number: NCT04615442
• Lead Sponsor: Epihunter NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-04
• Primary Completion: 2021-06-28
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Epihunter	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity for electrographic seizures of study device compared to video EEG	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	9 months	The number of false alarms by the study device \< 0.1 per hour (median false detection rate per recording)

Secondary Outcome Measures

Name	Time	Method
Feasibility testing of automated behavioral testing triggered by automated detection	3 months	Assess if automated behavioral testing triggered by automated detection can be used to automatically assess awareness during an absence seizure. Successful if subjects DO NOT react to the testing during an unaware seizure, and DO react during an aware seizure.

Trial Locations

Locations (4)

UZ Leuven; 🇧🇪 Leuven, Belgium

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Danish Epilepsy Center; 🇩🇰 Dianalund, Denmark

Institute of Neurology and Neuropsychology; 🇬🇪 Tbilisi, Georgia