EEG@HOME (Phase 4 of the Project)

Not Applicable

Withdrawn

• Conditions: Epilepsy
• Interventions: Other: video-EEG monitoring

• Registration Number: NCT02394639
• Lead Sponsor: University Hospital, Ghent

Brief Summary

The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

In this stage of the project video-EEG recording with the prototype will be compared to the conventional way (cup-electrodes and collodion) of recording in the EMU.

Minimum 1 - maximum 10 patients with prominent IEDs will be included. After the conventional recording is completed, the patient will undergo a recording of maximum 5 hours with the prototype.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience and experience of the EEG-technologists will also be collected.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Study Start: 2015-04
• Primary Completion: 2016-08
• Study Completion: 2016-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Epilepsy with on EEG prominent IEDs

Exclusion Criteria

• /

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional video-EEG monitoring	video-EEG monitoring	conventional video-EEG monitoring with cup-electrodes and collodion
video-EEG monitoring with prototype	video-EEG monitoring	video-EEG monitoring of 5 hours with EEG-cap with dry electrodes

Primary Outcome Measures

Name	Time	Method
EEG signal quality (visual and clinical) (scale)	5 hours
EEG signal quality (technical) (signal to noise ratio)	5 hours
User experience (questionnaire)	5 hours

Secondary Outcome Measures

Name	Time	Method
EEG-technologist experience (questionnaire)	5 hours

Trial Locations

Locations (2)

University Hospital, Leuven; 🇧🇪 Leuven, Belgium

University Hospital, Ghent; 🇧🇪 Ghent, Belgium