NCT04284072

Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	Sensor 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).

Timeline

• Start date: 2020-06-22
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2020-02-25
• Last updated: 2022-11-08

Locations

7 sites across 5 countries: Belgium, Germany, Portugal, Sweden, United Kingdom