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

November 27, 2017 updated by: Neurologie, University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital, Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional EEG-registration type 1
conventional EEG-registration with wet bridge electrodes and conductive gel
Device: EEG
Active Comparator: conventional EEG-registration type 2
conventional EEG-registration with wet cup electrodes and collodion
Device: EEG
Experimental: EEG-registration with dry electrodes
Device: EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EEG signal quality (visual and clinical) (scale)
Time Frame: 10 minutes
10 minutes
EEG signal quality (technical) (signal to noise ratio)
Time Frame: 10 minutes
10 minutes
User experience (questionnaire)
Time Frame: 10 minutes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Pilipili NV
Imec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 3, 2015

Study Record Updates

Last Update Posted (Actual)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2014/0319(2)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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