Clinical trial NCT04284072: Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Official title: A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Seizure detection
Wearable
Epilepsy
Seizure
Sensor Dot
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Freiburg University
name: King's College London
name: Oxford University Hospitals NHS Trust
name: University of Coimbra
name: Karolinska Institutet
name: RWTH Aachen University
name: UCB Pharma
name: Byteflies
name: Helpilepsy
First posted: 2020-02-25
Enrollment: 496
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to two weeks
measure: 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
timeFrame: up to two weeks
measure: 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
timeFrame: up to two weeks
measure: 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
timeFrame: up to two weeks
measure: 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
timeFrame: up to two weeks
measure: 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
timeFrame: up to two weeks
Secondary outcomes:
measure: Sensor Dot usability
timeFrame: up to two weeks
measure: To assess seizure duration
timeFrame: up to two weeks
measure: To assess the usability of the seizure e-diary
timeFrame: up to two weeks
measure: To evaluate the accuracy of automated seizure detection algorithms
timeFrame: 2 years
measure: Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
timeFrame: up to 2 weeks
measure: Sensor Dot Performance
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, department of Neurology
city: Aachen
country: Germany
facility: Department of Epileptology and Neurology
city: Freiburg
country: Germany
facility: Epilepsy Center, University Medical Center, Freiburg University
city: Coimbra
country: Portugal
facility: Division of Neurology, Coimbra University Hospital
city: Stockholm
country: Sweden
facility: Department of Clinical Neuroscience, Karolinska Institute
city: London
country: United Kingdom
facility: Division of Neuroscience, King's College London
city: Oxford
country: United Kingdom
facility: Nuffield Department of Clinical Neurosciences, Oxford University Hospital
Study officials:
affiliation: UZ Leuven and KU Leuven
name: Wim Van Paesschen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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