EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Device: EEG

• Registration Number: NCT02408627
• 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.

Phase 3 of the Project will be divided into a Phase 3a and Phase 3b.

Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.

Minimum 2 - maximum 10 epilepsy patients 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: 2015-01
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG

Exclusion Criteria

• Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional EEG-registration type 2	EEG	conventional EEG-registration with wet cup electrodes and collodion
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

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium