Status:
COMPLETED
Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Freiburg University
King's College London
Conditions:
Epilepsy
Eligibility:
All Genders
4+ years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT04284072
Start Date
June 22 2020
End Date
June 30 2022
Last Update
November 8 2022
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospitals Leuven, department of Neurology
Leuven, Belgium, 3000
2
Department of Epileptology and Neurology
Aachen, Germany
3
Epilepsy Center, University Medical Center, Freiburg University
Freiburg im Breisgau, Germany
4
Division of Neurology, Coimbra University Hospital
Coimbra, Portugal