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

NCT ID: NCT02408627

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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conventional EEG-registration type 1

conventional EEG-registration with wet bridge electrodes and conductive gel

Group Type ACTIVE_COMPARATOR

EEG

Intervention Type DEVICE

conventional EEG-registration type 2

conventional EEG-registration with wet cup electrodes and collodion

Group Type ACTIVE_COMPARATOR

EEG

Intervention Type DEVICE

EEG-registration with dry electrodes

EEG-registration with dry electrodes

Group Type EXPERIMENTAL

EEG

Intervention Type DEVICE

Interventions

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EEG

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pilipili NV

INDUSTRY

Sponsor Role collaborator

Imec

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Neurologie

Prof. dr. Kristl Vonck

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC/2014/1283

Identifier Type: -

Identifier Source: org_study_id