Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
- Conditions
- Epilepsy
- Interventions
- Device: Sensor Dot
- Registration Number
- NCT04284072
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description All subjects Sensor Dot 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.
- Primary Outcome Measures
Name Time Method 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
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
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
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
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
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
- Secondary Outcome Measures
Name Time Method 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
To assess the usability of the seizure e-diary up to two weeks We will asses usability of the electronic seizure diary
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.
To assess seizure duration up to two weeks From the Sensor Dot data, we will be able to assess seizure duration
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
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.
Trial Locations
- Locations (7)
Division of Neurology, Coimbra University Hospital
🇵🇹Coimbra, Portugal
University Hospitals Leuven, department of Neurology
🇧🇪Leuven, Belgium
Department of Clinical Neuroscience, Karolinska Institute
🇸🇪Stockholm, Sweden
Epilepsy Center, University Medical Center, Freiburg University
🇩🇪Freiburg, Germany
Department of Epileptology and Neurology
🇩🇪Aachen, Germany
Division of Neuroscience, King's College London
🇬🇧London, United Kingdom
Nuffield Department of Clinical Neurosciences, Oxford University Hospital
🇬🇧Oxford, United Kingdom