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

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ClinicalTrials.gov Identifier: NCT04284072
Recruitment Status : Completed
First Posted : February 25, 2020
Last Update Posted : November 8, 2022
Sponsor:
Collaborators:
Freiburg University
King's College London
Oxford University Hospital
University of Coimbra
Karolinska Institutet
RWTH Aachen University
UCB Pharma
Byteflies
Helpilepsy
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Sensor Dot Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Actual Study Start Date : June 22, 2020
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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).




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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

  2. To assess seizure duration [ Time Frame: up to two weeks ]
    From the Sensor Dot data, we will be able to assess seizure duration

  3. To assess the usability of the seizure e-diary [ Time Frame: up to two weeks ]
    We will asses usability of the electronic seizure diary

  4. 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.

  5. 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

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284072


Locations
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Belgium
University Hospitals Leuven, department of Neurology
Leuven, Belgium, 3000
Germany
Department of Epileptology and Neurology
Aachen, Germany
Epilepsy Center, University Medical Center, Freiburg University
Freiburg, Germany
Portugal
Division of Neurology, Coimbra University Hospital
Coimbra, Portugal
Sweden
Department of Clinical Neuroscience, Karolinska Institute
Stockholm, Sweden
United Kingdom
Division of Neuroscience, King's College London
London, United Kingdom
Nuffield Department of Clinical Neurosciences, Oxford University Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
Freiburg University
King's College London
Oxford University Hospital
University of Coimbra
Karolinska Institutet
RWTH Aachen University
UCB Pharma
Byteflies
Helpilepsy
Investigators
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Principal Investigator: Wim Van Paesschen, MD, PhD UZ Leuven and KU Leuven
Additional Information:
Publications:
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.

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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT04284072    
Other Study ID Numbers: S63631
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
Seizure detection
Wearable
Epilepsy
Seizure
Sensor Dot
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations