Back to resultsEEG@HOME (Phase 4 of the Project)
Primary Purpose
Epilepsy
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
video-EEG monitoring
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Epilepsy with on EEG prominent IEDs
Exclusion Criteria:
- /
Sites / Locations
- University Hospital, Ghent
- University Hospital, Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional video-EEG monitoring
video-EEG monitoring with prototype
Arm Description
conventional video-EEG monitoring with cup-electrodes and collodion
video-EEG monitoring of 5 hours with EEG-cap with dry electrodes
Outcomes
Primary Outcome Measures
EEG signal quality (visual and clinical) (scale)
EEG signal quality (technical) (signal to noise ratio)
User experience (questionnaire)
Secondary Outcome Measures
EEG-technologist experience (questionnaire)
Full Information
NCT ID
NCT02394639
First Posted
February 10, 2015
Last Updated
November 27, 2017
Sponsor
University Hospital, Ghent
Collaborators
Universitaire Ziekenhuizen KU Leuven, Pilipili NV, Imec
1. Study Identification
Unique Protocol Identification Number
NCT02394639
Brief Title
EEG@HOME (Phase 4 of the Project)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Project funding ended before reaching Phase 4.
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent
Collaborators
Universitaire Ziekenhuizen KU Leuven, 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 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.
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
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional video-EEG monitoring
Arm Type
Active Comparator
Arm Description
conventional video-EEG monitoring with cup-electrodes and collodion
Arm Title
video-EEG monitoring with prototype
Arm Type
Experimental
Arm Description
video-EEG monitoring of 5 hours with EEG-cap with dry electrodes
Intervention Type
Other
Intervention Name(s)
video-EEG monitoring
Primary Outcome Measure Information:
Title
EEG signal quality (visual and clinical) (scale)
Time Frame
5 hours
Title
EEG signal quality (technical) (signal to noise ratio)
Time Frame
5 hours
Title
User experience (questionnaire)
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
EEG-technologist experience (questionnaire)
Time Frame
5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Epilepsy with on EEG prominent IEDs
Exclusion Criteria:
/
Facility Information:
Facility Name
University Hospital, Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital, Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
EEG@HOME (Phase 4 of the Project)
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