CompletedNot Applicable

ECV - Epihunter Clinical Validation

United States, Belgium, Denmark102 participantsStarted 2020-05-01

Plain-language 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.

Who can participate

Age range4 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sensitivity for electrographic seizures of study device compared to video EEG

Timeframe: 9 months

Number of false alarms by study device per hour

Timeframe: 9 months

Trial details

NCT IDNCT04615442

SponsorEpihunter NV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-28

View on ClinicalTrials.gov More Absence Seizures trials