A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 496
- Locations
- 7
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to — (Child, Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Sensor Dot (Device)
Outcomes
Primary Outcomes
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
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
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
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
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
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
Secondary Outcomes
- To evaluate the accuracy of automated seizure detection algorithms(2 years)
- Sensor Dot usability(up to two weeks)
- To assess the usability of the seizure e-diary(up to two weeks)
- To assess seizure duration(up to two weeks)
- Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations(up to 2 weeks)
- Sensor Dot Performance(up to 2 weeks)