EEG@HOME (Phase 4 of the Project)

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.

Study Overview

• Status: Withdrawn
• Conditions: Epilepsy
• Intervention / Treatment: Other: video-EEG monitoring

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital, Ghent
  • Leuven, Belgium, 3000
    • University Hospital, Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Epilepsy with on EEG prominent IEDs

Exclusion Criteria:

• /

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional video-EEG monitoring; conventional video-EEG monitoring with cup-electrodes and collodion	Other: video-EEG monitoring
Experimental: video-EEG monitoring with prototype; video-EEG monitoring of 5 hours with EEG-cap with dry electrodes	Other: video-EEG monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
EEG-technologist experience (questionnaire)	5 hours

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Universitaire Ziekenhuizen KU Leuven; Pilipili NV; Imec

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: EC/2015/0140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No