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Completed

NCT Number: NCT04615442

ECV - Epihunter Clinical Validation

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.

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Key information

Conditions

Absence Seizures Absence Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Absence Epilepsy, Generalized Epileptic Syndromes Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epihunter

Device

Subjects wear epihunter during routine video EEG

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Feasibility testing of automated behavioral testing triggered by automated detection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Epihunter NV

Industry

Collaborators

  • Boston Children's Hospital
  • Filadelfia Epilepsy Hospital
  • Institute of Neurology and Neuropsychology, Tbilisi, Georgia
  • KU Leuven

Registry information

Acronym: ECV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 4, 2020
Registry last updated
Apr 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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