Advanced EEG Technology in Childhood Epilepsy

Universitaire Ziekenhuizen KU Leuven130 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Epilepsy in Children Sleep Disorder

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Accuracy of seizure detection in-hospital

Accuracy (F1 score, precision and recall) of wearable multimodal device for seizure detection. Comparison of data with golden standard video EEG.

Time frame: 24 hours

Accuracy of sleep monitoring in-hospital

Assessment of sleep parameters with wearable multimodal device. Comparison of data with golden standard video EEG. Sleep scoring will be done according to American Academy of Sleep Medicine.

Time frame: 24 hours

Secondary Outcomes

Accuracy of seizure detection at home

Accuracy of wearable multimodal device for seizure detection versus seizure diary filled out by the participant or caregiver.

Time frame: 1-21 days

Accuracy of sleep monitoring at home

Accuracy of sleep monitoring of the wearable multimodal device versus sleep checklist (Sleep Behavior Questionnaire (SQ-SP A.P.H.M. Maas, W. Braam, R. Didden, M. Smits, \& L.M.G. Curfs 2005 )