Back to resultsECV - Epihunter Clinical Validation (ECV)
Primary Purpose
Absence Seizures, Absence Epilepsy
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Epihunter
Sponsored by
About this trial
This is an interventional diagnostic trial for Absence Seizures
Eligibility Criteria
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
Sites / Locations
- Boston Children's Hospital
- UZ Leuven
- Danish Epilepsy Center
- Institute of Neurology and Neuropsychology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All subjects
Arm 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.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04615442
First Posted
September 14, 2020
Last Updated
April 1, 2022
Sponsor
Epihunter NV
Collaborators
Filadelfia Epilepsy Hospital, KU Leuven, Boston Children's Hospital, Institute of Neurology and Neuropsychology, Tbilisi, Georgia
1. Study Identification
Unique Protocol Identification Number
NCT04615442
Brief Title
ECV - Epihunter Clinical Validation
Acronym
ECV
Official Title
ECV - Epihunter Clinical Validation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 28, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epihunter NV
Collaborators
Filadelfia Epilepsy Hospital, KU Leuven, Boston Children's Hospital, Institute of Neurology and Neuropsychology, Tbilisi, Georgia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Absence Seizures, Absence Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Epihunter
Intervention Description
Subjects wear epihunter during routine video EEG
Primary Outcome Measure Information:
Title
Sensitivity for electrographic seizures of study device compared to video EEG
Description
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)
Time Frame
9 months
Title
Number of false alarms by study device per hour
Description
The number of false alarms by the study device < 0.1 per hour (median false detection rate per recording)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Feasibility testing of automated behavioral testing triggered by automated detection
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk Loeckx, PhD
Organizational Affiliation
Epihunter NV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Danish Epilepsy Center
City
Dianalund
Country
Denmark
Facility Name
Institute of Neurology and Neuropsychology
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Learn more about this trial
ECV - Epihunter Clinical Validation
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