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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sensor Dot
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring Seizure detection, Wearable, Epilepsy, Seizure, Sensor Dot

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven, department of Neurology
  • Department of Epileptology and Neurology
  • Epilepsy Center, University Medical Center, Freiburg University
  • Division of Neurology, Coimbra University Hospital
  • Department of Clinical Neuroscience, Karolinska Institute
  • Division of Neuroscience, King's College London
  • Nuffield Department of Clinical Neurosciences, Oxford University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Sensor Dot usability
We will assess the usability of the device as perceived by users (patients and healthcare personnel) via surveys
To assess seizure duration
From the Sensor Dot data, we will be able to assess seizure duration
To assess the usability of the seizure e-diary
We will asses usability of the electronic seizure diary
To evaluate the accuracy of automated seizure detection algorithms
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.
Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
Accuracy as determined by expert reviewers
Sensor Dot Performance
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.

Full Information

First Posted
February 17, 2020
Last Updated
November 7, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Freiburg University, King's College London, Oxford University Hospital, University of Coimbra, Karolinska Institutet, RWTH Aachen University, UCB Pharma, Byteflies, Helpilepsy
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1. Study Identification

Unique Protocol Identification Number
NCT04284072
Brief Title
Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Acronym
SeizeIT2
Official Title
A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Freiburg University, King's College London, Oxford University Hospital, University of Coimbra, Karolinska Institutet, RWTH Aachen University, UCB Pharma, Byteflies, Helpilepsy

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Seizure detection, Wearable, Epilepsy, Seizure, Sensor Dot

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sensor Dot
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
F1-score as determined by expert reviewers
Time Frame
up to two weeks
Title
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
Description
F1-score as determined by expert reviewers
Time Frame
up to two weeks
Title
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
Description
F1-score as determined by expert reviewers
Time Frame
up to two weeks
Title
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
Description
F1-score as determined by expert reviewers
Time Frame
up to two weeks
Title
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
Description
F1-score as determined by expert reviewers
Time Frame
up to two weeks
Title
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
Description
F1-score as determined by expert reviewers
Time Frame
up to two weeks
Secondary Outcome Measure Information:
Title
Sensor Dot usability
Description
We will assess the usability of the device as perceived by users (patients and healthcare personnel) via surveys
Time Frame
up to two weeks
Title
To assess seizure duration
Description
From the Sensor Dot data, we will be able to assess seizure duration
Time Frame
up to two weeks
Title
To assess the usability of the seizure e-diary
Description
We will asses usability of the electronic seizure diary
Time Frame
up to two weeks
Title
To evaluate the accuracy of automated seizure detection algorithms
Description
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.
Time Frame
2 years
Title
Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
Description
Accuracy as determined by expert reviewers
Time Frame
up to 2 weeks
Title
Sensor Dot Performance
Description
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.
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Van Paesschen, MD, PhD
Organizational Affiliation
UZ Leuven and KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven, department of Neurology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Department of Epileptology and Neurology
City
Aachen
Country
Germany
Facility Name
Epilepsy Center, University Medical Center, Freiburg University
City
Freiburg
Country
Germany
Facility Name
Division of Neurology, Coimbra University Hospital
City
Coimbra
Country
Portugal
Facility Name
Department of Clinical Neuroscience, Karolinska Institute
City
Stockholm
Country
Sweden
Facility Name
Division of Neuroscience, King's College London
City
London
Country
United Kingdom
Facility Name
Nuffield Department of Clinical Neurosciences, Oxford University Hospital
City
Oxford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
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Links:
URL
https://www.eithealth.eu/seizeit2
Description
EIT Health website referring to our SeizeIT2 project

Learn more about this trial

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

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