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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Epilepsy

Treatments: Device: EEG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02408627

EC/2014/1283

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 6 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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3 participants in 3 patient groups

conventional EEG-registration type 1

Active Comparator group

Description:

conventional EEG-registration with wet bridge electrodes and conductive gel

Treatment:

Device: EEG

conventional EEG-registration type 2

Active Comparator group

Description:

conventional EEG-registration with wet cup electrodes and collodion

Treatment:

Device: EEG

EEG-registration with dry electrodes

Experimental group

Description:

EEG-registration with dry electrodes

Treatment:

Device: EEG