ECV - Epihunter Clinical Validation

Absence Epilepsy Clinical Trial

— ECV  

Official title:

ECV - Epihunter Clinical Validation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615442
• Other study ID #: EPI2019B
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Epihunter NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 31, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Absence Epilepsy
• Absence Seizures
• Epilepsy, Absence
• Seizures

Intervention

Device:
• Epihunter
Subjects wear epihunter during routine video EEG

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Denmark	Danish Epilepsy Center	Dianalund
Georgia	Institute of Neurology and Neuropsychology	Tbilisi
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Epihunter NV	Boston Children's Hospital, Filadelfia Epilepsy Hospital, Institute of Neurology and Neuropsychology, Tbilisi, Georgia, KU Leuven

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for electrographic seizures of study device compared to video EEG	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)	9 months
Primary	Number of false alarms by study device per hour	The number of false alarms by the study device < 0.1 per hour (median false detection rate per recording)	9 months
Secondary	Feasibility testing of automated behavioral testing triggered by automated detection	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.	3 months