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

NCT02408653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-11-28

No results posted yet for this study

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.

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.

Conditions

Interventions

DEVICE

EEG

Sponsors & Collaborators

  • Pilipili NV

    collaborator INDUSTRY

  • Imec

    collaborator INDUSTRY

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408653 on ClinicalTrials.gov