EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Device: EEG

• Registration Number: NCT02408653
• 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 Phase 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes.

Minimum 2 - maximum 10 healthy volunteers will be included.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional EEG-registration type 1	EEG	conventional EEG-registration with wet bridge electrodes and conductive gel
EEG-registration with dry electrodes	EEG	EEG-registration with dry electrodes
conventional EEG-registration type 2	EEG	conventional EEG-registration with wet cup electrodes and collodion

Primary Outcome Measures

Name	Time	Method
User experience (questionnaire)	10 minutes
EEG signal quality (visual and clinical) (scale)	10 minutes
EEG signal quality (technical) (signal to noise ratio)	10 minutes

Trial Locations

Locations (1)

University Hospital, Ghent; 🇧🇪 Ghent, Belgium