Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology (SeizeIT2)

November 7, 2022 updated by: Universitaire Ziekenhuizen KU Leuven

A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.

A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.

The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.

Study Type

Interventional

Enrollment (Actual)

496

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, 3000
        • University Hospitals Leuven, department of Neurology
  • Germany
      • Aachen, Germany
        • Department of Epileptology and Neurology
      • Freiburg, Germany
        • Epilepsy Center, University Medical Center, Freiburg University
  • Portugal
      • Coimbra, Portugal
        • Division of Neurology, Coimbra University Hospital
  • Sweden
      • Stockholm, Sweden
        • Department of Clinical Neuroscience, Karolinska Institute
  • United Kingdom
      • London, United Kingdom
        • Division of Neuroscience, King's College London
      • Oxford, United Kingdom
        • Nuffield Department of Clinical Neurosciences, Oxford University 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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All subjects
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: up to two weeks
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
Time Frame: up to two weeks
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
Time Frame: up to two weeks
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
Time Frame: up to two weeks
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
Time Frame: up to two weeks
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
Time Frame: up to two weeks
F1-score as determined by expert reviewers
up to two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensor Dot usability
Time Frame: up to two weeks
We will assess the usability of the device as perceived by users (patients and healthcare personnel) via surveys
up to two weeks
To assess seizure duration
Time Frame: up to two weeks
From the Sensor Dot data, we will be able to assess seizure duration
up to two weeks
To assess the usability of the seizure e-diary
Time Frame: up to two weeks
We will asses usability of the electronic seizure diary
up to two weeks
To evaluate the accuracy of automated seizure detection algorithms
Time Frame: 2 years
We will use the collected data and seizure annotations to develop algorithms to automatically detect epileptic seizures. We plan to evaluate how accurate these new automated seizure detection algorithms are.
2 years
Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
Time Frame: up to 2 weeks
Accuracy as determined by expert reviewers
up to 2 weeks
Sensor Dot Performance
Time Frame: up to 2 weeks
We will assess the technical performance of the device by comparing the actual length of recorded data against the expected recording length, and what percentage of the data is high quality enough to make seizure annotations.
up to 2 weeks

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

King's College London
Karolinska Institutet
UCB Pharma
University of Coimbra
RWTH Aachen University
Byteflies
Oxford University Hospital
Freiburg University
Helpilepsy

Investigators

  • Principal Investigator: Wim Van Paesschen, MD, PhD, UZ Leuven and KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 22, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S63631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be shared from 1-1-2024. We do not foresee an end-date.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • Study Protocol

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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