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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Sensor Dot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>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<br>* 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).<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | 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 | 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 | F1-score as determined by expert reviewers | up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor Dot usability | 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 | 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 | We will asses usability of the electronic seizure diary | up to two weeks | 
| 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. | 2 years | 
| Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations | Accuracy as determined by expert reviewers | up to 2 weeks | 
| 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. | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seizure detection, Wearable, Epilepsy, Seizure, Sensor Dot