EEG@HOME (Phase 1 of the Project)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Interview
Sponsored by

About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Epilepsy patient or EEG-technologist or neurologist
Exclusion Criteria:
- No experience with EEG
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Interview
Arm Description
Interview of epilepsy patients and their family about their experience with epilepsy, EEG registrations and daily life. Interview of EEG-technologists and neurologists about their experience with EEG registrations and expections when thinking of a ideal EEG-cap.
Outcomes
Primary Outcome Measures
User wishes and expectations (questionnaire)
Secondary Outcome Measures
Full Information
NCT ID
NCT02408666
First Posted
March 31, 2015
Last Updated
December 7, 2015
Sponsor
University Hospital, Ghent
Collaborators
Pilipili NV, Imec
1. Study Identification
Unique Protocol Identification Number
NCT02408666
Brief Title
EEG@HOME (Phase 1 of the Project)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent
Collaborators
Pilipili NV, Imec
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interview
Arm Type
Other
Arm Description
Interview of epilepsy patients and their family about their experience with epilepsy, EEG registrations and daily life.
Interview of EEG-technologists and neurologists about their experience with EEG registrations and expections when thinking of a ideal EEG-cap.
Intervention Type
Other
Intervention Name(s)
Interview
Primary Outcome Measure Information:
Title
User wishes and expectations (questionnaire)
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Epilepsy patient or EEG-technologist or neurologist
Exclusion Criteria:
No experience with EEG
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
EEG@HOME (Phase 1 of the Project)
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