ECV - Epihunter Clinical Validation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04615442

Acronym

ECV

Enrollment

102

Registered

2020-11-04

Start date

2020-05-01

Completion date

2021-12-31

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absence Epilepsy, Absence Seizures

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.

Interventions

DEVICEEpihunter

Subjects wear epihunter during routine video EEG

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Belgium, Denmark, Georgia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026