ECV - Epihunter Clinical Validation (ECV)

April 1, 2022 updated by: Epihunter NV
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • Denmark
      • Dianalund, Denmark
        • Danish Epilepsy Center
  • Georgia
      • Tbilisi, Georgia
        • Institute of Neurology and Neuropsychology
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All subjects
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.
Device: Epihunter
Subjects wear epihunter during routine video EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
9 months
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)
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epihunter NV

Collaborators

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

Investigators

  • Principal Investigator: Dirk Loeckx, PhD, Epihunter NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

June 28, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI2019B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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