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

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.

Conditions

• Epilepsy

Interventions

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).

Sponsors & Collaborators

• Freiburg University

  collaborator UNKNOWN

• King's College London

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• University of Coimbra

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• RWTH Aachen University

  collaborator OTHER

• UCB Pharma

  collaborator INDUSTRY

• Byteflies

  collaborator INDUSTRY

• Helpilepsy

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Wim Van Paesschen, MD, PhD · UZ Leuven and KU Leuven

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-22

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• Belgium
• Germany
• Portugal
• Sweden
• United Kingdom

Study Locations