Epilepsy
Conditions
Keywords
Seizure detection, Wearable, Epilepsy, Seizure, Sensor Dot
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.
Interventions
DEVICESensor 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).
Sponsors
Freiburg University
King's College London
Oxford University Hospitals NHS Trust
University of Coimbra
Karolinska Institutet
RWTH Aachen University
UCB Pharma
Byteflies
Helpilepsy
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 seizure duration | up to two weeks | From the Sensor Dot data, we will be able to assess seizure duration |
| 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. |
| 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. |
Countries
Belgium, Germany, Portugal, Sweden, United Kingdom
Outcome results
None listed