Image

Advanced EEG Technology in Childhood Epilepsy

Advanced EEG Technology in Childhood Epilepsy

Non Recruiting
4-18 years
All
Phase N/A

Powered by AI

Overview

A lot of effort has already been put into the development of smaller, wearable and more user-friendly devices to monitor seizures in patients with epilepsy.

The investigators hypothesize that a wearable EEG ( in combination with additional non-EEG biosignals (motion, ECG, EMG, respiration, temperature,...) derived from Byteflies Sensor Dot and new medical patches (Plug 'n Patch system), will be able to objectively detect epileptic seizures and monitor sleep in the hospital and home environment for specific types of childhood epilepsy.

The accuracy of seizure detection and sleep monitoring by the wearable miniature EEG device in combination with other (autonomic) biosignals (full PnP system) will be compared with the golden standard video-EEG and seizure and sleep diaries filled-out by the participants.

Description

The objective of the study will be the following:

  1. Multimodal seizure detection Evaluation of data quality and seizure annotation accuracy. Comparison of data derived from the multimodal wearable device (Sensor dot in combination with Plug and Patch system) versus video EEG and seizure diary in childhood epilepsy syndromes with
    • Tonic seizures
    • Atonic seizures
    • Myoclonic seizures During wakefulness and during sleep
  2. Sleep monitoring Assessment of sleep data quality, latency, sleep fragmentation and time spent in different sleep stages in different childhood epilepsy syndromes. Investigation of the influence of occuring seizures on sleep architecture.

Comparison of data wearable device (Byteflies Sensor Dot in combination with Plug and Patch system) versus video-EEG and sleep diary in childhood epilepsy syndromes.

Eligibility

Inclusion Criteria:

  • Childhood epilepsy with tonic, atonic or myoclonic seizures
  • Parental informed consent and assent of the child if applicable
  • Parent or caregiver can keep a seizure and sleep diary reliably.

Exclusion criteria

  • Inability to provide written informed consent by parent or caregiver.
  • Known allergy to electrodes or medical adhesives used as part of the study protocol.
  • Having an implanted device, such as (but not limited to) a pacemaker, ICD, VNS because Sensor Dot contains magnets that could interfere with the operation of these devices.
  • Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.

Study details
    Epilepsy in Children
    Sleep Disorder

NCT04584385

Universitaire Ziekenhuizen KU Leuven

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.