NCT04615442

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

September 14, 2020

Last Update Submit

April 1, 2022

Conditions

Absence SeizuresAbsence Epilepsy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Feasibility testing of automated behavioral testing triggered by automated detection

    3 months

Study Arms (1)

All subjects

EXPERIMENTAL

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

Interventions

EpihunterDEVICE

Subjects wear epihunter during routine video EEG

All subjects

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

UZ Leuven

Leuven, Belgium

Location

Danish Epilepsy Center

Dianalund, Denmark

Location

Institute of Neurology and Neuropsychology

Tbilisi, Georgia

Location

MeSH Terms

Conditions

SeizuresEpilepsy, Absence

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEpilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesEpileptic Syndromes

Study Officials

  • Dirk Loeckx, PhD

    Epihunter NV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2020

First Posted

November 4, 2020

Study Start

May 1, 2020

Primary Completion

June 28, 2021

Study Completion

December 31, 2021

Last Updated

April 4, 2022

Record last verified: 2022-04

Locations

US(1)DK(1)BE(1)GE(1)