Back to resultsEEG@HOME (Phase 3b of the Project, Interviews)
Primary Purpose
Epilepsy
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Interview about prototype EEG-cap
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Epilepsy patient
Exclusion Criteria:
- No experience with EEG
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interview
Arm Description
Interview of epilepsy patients and their family about their opinion on different EEG-cap models in development.
Outcomes
Primary Outcome Measures
User opinion (questionnaire)
Secondary Outcome Measures
Full Information
NCT ID
NCT02428348
First Posted
March 31, 2015
Last Updated
November 27, 2017
Sponsor
University Hospital, Ghent
Collaborators
Pilipili NV, Imec
1. Study Identification
Unique Protocol Identification Number
NCT02428348
Brief Title
EEG@HOME (Phase 3b of the Project, Interviews)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Project funding ended before Phase 3b could be completed.
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
October 2015 (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.
Phase 3 of this Project will be divided into Phase 3a and Phase 3b.
In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour.
Minimum 4 - maximum 20 epilepsy patients and their family 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
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interview
Arm Type
Experimental
Arm Description
Interview of epilepsy patients and their family about their opinion on different EEG-cap models in development.
Intervention Type
Other
Intervention Name(s)
Interview about prototype EEG-cap
Primary Outcome Measure Information:
Title
User opinion (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
No
Eligibility Criteria
Inclusion Criteria:
Epilepsy patient
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 3b of the Project, Interviews)
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