Advanced EEG Technology in Childhood Epilepsy

NCT04584385 | Completed DMC

• 1 other identifier: s64658
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy in Children; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 hours

Secondary Outcomes (2)

• Accuracy of seizure detection at home

  1-21 days

• Accuracy of sleep monitoring at home

  1-21 days

Study Arms (1)

Childhood epilepsy

Children with refractory tonic, myoclonic or atonic seizures

Diagnostic Test: EEG

Interventions

EEG DIAGNOSTIC_TEST

EEG monitoring

Childhood epilepsy

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children between 4 and 18 years old with epilepsy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Byteflies: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• Proost R, Heremans E, Lagae L, Van Paesschen W, De Vos M, Jansen K. Automated sleep staging on reduced channels in children with epilepsy. Front Neurol. 2024 May 10;15:1390465. doi: 10.3389/fneur.2024.1390465. eCollection 2024.

  PMID: 38798709 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 14, 2020
• Study Start: February 1, 2021
• Primary Completion: March 8, 2023
• Study Completion: March 8, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)