ECV - Epihunter Clinical Validation

Epihunter

Status: Completed

Conditions: Absence Seizures; Absence Epilepsy

Treatments: Device: Epihunter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04615442

EPI2019B

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 4+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

All subjects

Experimental group

Description:

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.

Treatment:

Device: Epihunter