NCT04284072

Brief Summary

Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
5 countries

7 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

First Submitted

Initial submission to the registry

February 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

June 22, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

November 8, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

February 17, 2020

Last Update Submit

November 7, 2022

Conditions

Epilepsy

Keywords

Seizure detectionWearableEpilepsySeizureSensor Dot

Outcome Measures

Primary Outcomes (6)

  • Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness

    F1-score as determined by expert reviewers

    up to two weeks

  • Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep

    F1-score as determined by expert reviewers

    up to two weeks

  • Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness

    F1-score as determined by expert reviewers

    up to two weeks

  • Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep

    F1-score as determined by expert reviewers

    up to two weeks

  • Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness

    F1-score as determined by expert reviewers

    up to two weeks

  • Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep

    F1-score as determined by expert reviewers

    up to two weeks

Secondary Outcomes (6)

  • Sensor Dot usability

    up to two weeks

  • To assess seizure duration

    up to two weeks

  • To assess the usability of the seizure e-diary

    up to two weeks

  • To evaluate the accuracy of automated seizure detection algorithms

    2 years

  • Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations

    up to 2 weeks

  • +1 more secondary outcomes

Study Arms (1)

All subjects

EXPERIMENTAL

Single arm study with a device intervention for epileptic seizure monitoring in subjects with refractory focal impaired awareness, tonic-clonic, and/or typical absence seizures.

Device: Sensor Dot

Interventions

Sensor DotDEVICE

Multimodal (EEG, ECG, EMG and motion) seizure monitoring with Sensor Dot to complement EMU-based video-EEG monitoring (EMU Phase), and optional home-based seizure diary logging (Home Phase).

All subjects

Eligibility Criteria

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

You may qualify if:

  • Subjects (4+ years old) with refractory epilepsy who are admitted to the hospital for clinically-indicated long-term video-EEG assessment or presurgical evaluation, and a high likelihood of experiencing seizures during the EMU Phase
  • For subjects continuing into the Home Phase: successful recording of their habitual seizures with Sensor Dot during the EMU Phase
  • For subjects continuing into the Home Phase: the ability to keep an e-diary

You may not qualify if:

  • Known allergies to any of the biopotential electrodes or adhesives used as part of the study protocol
  • Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device because Sensor Dot contains magnets that could interfere with the operation of these devices
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Hospitals Leuven, department of Neurology

Leuven, 3000, Belgium

Location

Department of Epileptology and Neurology

Aachen, Germany

Location

Epilepsy Center, University Medical Center, Freiburg University

Freiburg im Breisgau, Germany

Location

Division of Neurology, Coimbra University Hospital

Coimbra, Portugal

Location

Department of Clinical Neuroscience, Karolinska Institute

Stockholm, Sweden

Location

Division of Neuroscience, King's College London

London, United Kingdom

Location

Nuffield Department of Clinical Neurosciences, Oxford University Hospital

Oxford, United Kingdom

Location

Related Publications (17)

  • Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.

    PMID: 24730690BACKGROUND

  • Sander JW. The epidemiology of epilepsy revisited. Curr Opin Neurol. 2003 Apr;16(2):165-70. doi: 10.1097/01.wco.0000063766.15877.8e.

    PMID: 12644744BACKGROUND

  • Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

    PMID: 10660394BACKGROUND

  • Elger CE, Hoppe C. Diagnostic challenges in epilepsy: seizure under-reporting and seizure detection. Lancet Neurol. 2018 Mar;17(3):279-288. doi: 10.1016/S1474-4422(18)30038-3.

    PMID: 29452687BACKGROUND

  • Hoppe C, Poepel A, Elger CE. Epilepsy: accuracy of patient seizure counts. Arch Neurol. 2007 Nov;64(11):1595-9. doi: 10.1001/archneur.64.11.1595.

    PMID: 17998441BACKGROUND

  • Kurada AV, Srinivasan T, Hammond S, Ulate-Campos A, Bidwell J. Seizure detection devices for use in antiseizure medication clinical trials: A systematic review. Seizure. 2019 Mar;66:61-69. doi: 10.1016/j.seizure.2019.02.007. Epub 2019 Feb 13.

    PMID: 30802844BACKGROUND

  • Bidwell J, Khuwatsamrit T, Askew B, Ehrenberg JA, Helmers S. Seizure reporting technologies for epilepsy treatment: A review of clinical information needs and supporting technologies. Seizure. 2015 Nov;32:109-17. doi: 10.1016/j.seizure.2015.09.006. Epub 2015 Sep 18.

    PMID: 26552573BACKGROUND

  • Beniczky S, Ryvlin P. Standards for testing and clinical validation of seizure detection devices. Epilepsia. 2018 Jun;59 Suppl 1:9-13. doi: 10.1111/epi.14049.

    PMID: 29873827BACKGROUND

  • Szabo CA, Morgan LC, Karkar KM, Leary LD, Lie OV, Girouard M, Cavazos JE. Electromyography-based seizure detector: Preliminary results comparing a generalized tonic-clonic seizure detection algorithm to video-EEG recordings. Epilepsia. 2015 Sep;56(9):1432-7. doi: 10.1111/epi.13083. Epub 2015 Jul 20.

    PMID: 26190150BACKGROUND

  • Beniczky S, Conradsen I, Wolf P. Detection of convulsive seizures using surface electromyography. Epilepsia. 2018 Jun;59 Suppl 1:23-29. doi: 10.1111/epi.14048.

    PMID: 29873829BACKGROUND

  • Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8.

    PMID: 23398578BACKGROUND

  • Kjaer TW, Sorensen HBD, Groenborg S, Pedersen CR, Duun-Henriksen J. Detection of Paroxysms in Long-Term, Single-Channel EEG-Monitoring of Patients with Typical Absence Seizures. IEEE J Transl Eng Health Med. 2017 Jan 9;5:2000108. doi: 10.1109/JTEHM.2017.2649491. eCollection 2017.

    PMID: 29018634BACKGROUND

  • Zibrandtsen IC, Kidmose P, Christensen CB, Kjaer TW. Ear-EEG detects ictal and interictal abnormalities in focal and generalized epilepsy - A comparison with scalp EEG monitoring. Clin Neurophysiol. 2017 Dec;128(12):2454-2461. doi: 10.1016/j.clinph.2017.09.115. Epub 2017 Oct 12.

    PMID: 29096220BACKGROUND

  • Gu Y, Cleeren E, Dan J, Claes K, Van Paesschen W, Van Huffel S, Hunyadi B. Comparison between Scalp EEG and Behind-the-Ear EEG for Development of a Wearable Seizure Detection System for Patients with Focal Epilepsy. Sensors (Basel). 2017 Dec 23;18(1):29. doi: 10.3390/s18010029.

    PMID: 29295522BACKGROUND

  • Dan J, Weckhuysen D, Cleeren E, Van Paesschen W, Vandendriessche B. Technical validation of Sensor Dot: a wearable for ambulatory monitoring of epileptic seizures. 2nd International Congress on mobile devices and seizure detection in epilepsy; Lausanne, Switzerland, 2019.

    BACKGROUND

  • Seeck M, Koessler L, Bast T, Leijten F, Michel C, Baumgartner C, He B, Beniczky S. The standardized EEG electrode array of the IFCN. Clin Neurophysiol. 2017 Oct;128(10):2070-2077. doi: 10.1016/j.clinph.2017.06.254. Epub 2017 Jul 17.

    PMID: 28778476BACKGROUND

  • Macea J, Heremans ERM, Proost R, De Vos M, Van Paesschen W. Automated Sleep Staging in Epilepsy Using Deep Learning on Standard Electroencephalogram and Wearable Data. J Sleep Res. 2025 Oct;34(5):e70061. doi: 10.1111/jsr.70061. Epub 2025 Apr 3.

    PMID: 40176726DERIVED

Related Links

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wim Van Paesschen, MD, PhD

    UZ Leuven and KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 25, 2020

Study Start

June 22, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 8, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

We plan to share the individual biosignals (EEG, EMG, ECG and movement) and 24-channel seizure-annotated EEG data, de-identified demographic and epilepsy-related data two years after the finish of the study (1-1-2024) upon request to researchers who provide a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be shared from 1-1-2024. We do not foresee an end-date.
Access Criteria
Data will be made available upon request to researchers who provide a methodologically sound proposal. Proposals should be directed to Wim.vanpaesschen@uzleuven.be

Locations

SE(1)PT(1)BE(1)DE(2)GB(2)