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

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408653
• Other study ID #: EC/2014/0319(2)
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: November 27, 2017
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2017
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• EEG

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent	Ghent

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Ghent	Imec, Pilipili NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG signal quality (visual and clinical) (scale)		10 minutes
Primary	EEG signal quality (technical) (signal to noise ratio)		10 minutes
Primary	User experience (questionnaire)		10 minutes