Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Epilepsy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 4 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04284072
- Collaborators
- Freiburg University
- King's College London
- Oxford University Hospital
- University of Coimbra
- Karolinska Institutet
- RWTH Aachen University
- UCB Pharma
- Byteflies
- Helpilepsy
- Investigators
- Principal Investigator: Wim Van Paesschen, MD, PhD UZ Leuven and KU Leuven
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