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EEG@HOME (Phase 4 of the Project)

NCT ID: NCT02394639

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-09-30

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.

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.

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 video-EEG monitoring

conventional video-EEG monitoring with cup-electrodes and collodion

Group Type ACTIVE_COMPARATOR

video-EEG monitoring

Intervention Type OTHER

video-EEG monitoring with prototype

video-EEG monitoring of 5 hours with EEG-cap with dry electrodes

Group Type EXPERIMENTAL

video-EEG monitoring

Intervention Type OTHER

Interventions

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video-EEG monitoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Epilepsy with on EEG prominent IEDs

Exclusion Criteria

* /
Minimum Eligible Age

4 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

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

University Hospital, Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC/2015/0140

Identifier Type: -

Identifier Source: org_study_id