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

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Recruiting
CT.gov ID
NCT04284072
Collaborator
Freiburg University (Other), King's College London (Other), Oxford University Hospital (Other), University of Coimbra (Other), Karolinska Institutet (Other), RWTH Aachen University (Other), UCB Pharma (Industry), Byteflies (Industry), Helpilepsy (Other)
500
Enrollment
4
Locations
1
Arm
24.2
Anticipated Duration (Months)
125
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sensor Dot
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 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 :
Jun 22, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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).

Outcome Measures

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 [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 [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 [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 [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 [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 [up to two weeks]

    F1-score as determined by expert reviewers

Secondary Outcome Measures

  1. Sensor Dot usability [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 [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 [up to two weeks]

    We will asses usability of the electronic seizure diary

  4. To evaluate the accuracy of automated seizure detection algorithms [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 [up to 2 weeks]

    Accuracy as determined by expert reviewers

  6. Sensor Dot Performance [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven, department of Neurology Leuven Belgium 3000
2 Department of Epileptology and Neurology Aachen Germany
3 Epilepsy Center, University Medical Center, Freiburg University Freiburg Germany
4 Department of Clinical Neuroscience, Karolinska Institute Stockholm Sweden

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT04284072
Other Study ID Numbers:
  • S63631
First Posted:
Feb 25, 2020
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universitaire Ziekenhuizen Leuven
Seizure detection
Wearable
Epilepsy
Seizure
Sensor Dot
Additional relevant MeSH terms:
Epilepsy
Seizures

Study Results

No Results Posted as of May 19, 2022