EEG@HOME (Phase 1 of the Project)

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408666
• Other study ID #: EC/2014/0319
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: December 7, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• 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 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.

Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed.

The results of the interviews will be analysed by the design company pilipili nv.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

• Epilepsy patient or EEG-technologist or neurologist

Exclusion Criteria:

• No experience with EEG

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Interview

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	User wishes and expectations (questionnaire)		1 hour	No