EEG@HOME (Phase 4 of the Project)

Epilepsy Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02394639
• Other study ID #: EC/2015/0140
• Status: Withdrawn
• Phase: N/A
• First received: February 10, 2015
• Last updated: November 27, 2017
• Start date: April 2015
• Est. completion date: September 2016

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 80 Years

Eligibility

Inclusion Criteria:

• Epilepsy with on EEG prominent IEDs

Exclusion Criteria:

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• video-EEG monitoring

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent	Ghent
Belgium	University Hospital, Leuven	Leuven

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Ghent	Imec, Pilipili NV, Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG signal quality (visual and clinical) (scale)		5 hours
Primary	EEG signal quality (technical) (signal to noise ratio)		5 hours
Primary	User experience (questionnaire)		5 hours
Secondary	EEG-technologist experience (questionnaire)		5 hours