Back to resultsEEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EEG
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG
Exclusion Criteria:
- Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on EEG
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
conventional EEG-registration type 1
conventional EEG-registration type 2
EEG-registration with dry electrodes
Arm Description
conventional EEG-registration with wet bridge electrodes and conductive gel
conventional EEG-registration with wet cup electrodes and collodion
EEG-registration 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
Full Information
NCT ID
NCT02408627
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
NCT02408627
Brief Title
EEG@HOME (Phase 3a of the Project, Comparison of EEG-recordings)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 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 the Project will be divided into a Phase 3a and Phase 3b.
Phase 3a of the project will comprise of an EEG-registration with the different types of electrodes in epilepsy patients with prominent interictal epileptiform discharges (IEDs) on EEG. For each epilepsy patient the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-recording will take approximately 10 minutes.
Minimum 2 - maximum 10 epilepsy patients will be included.
There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience 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
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
conventional EEG-registration type 1
Arm Type
Active Comparator
Arm Description
conventional EEG-registration with wet bridge electrodes and conductive gel
Arm Title
conventional EEG-registration type 2
Arm Type
Active Comparator
Arm Description
conventional EEG-registration with wet cup electrodes and collodion
Arm Title
EEG-registration with dry electrodes
Arm Type
Experimental
Arm Description
EEG-registration with dry electrodes
Intervention Type
Device
Intervention Name(s)
EEG
Primary Outcome Measure Information:
Title
EEG signal quality (visual and clinical) (scale)
Time Frame
10 minutes
Title
EEG signal quality (technical) (signal to noise ratio)
Time Frame
10 minutes
Title
User experience (questionnaire)
Time Frame
10 minutes
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 patients with prominent interictal epileptiform discharges (IEDs) on EEG
Exclusion Criteria:
Epilepsy patients with no prominent interictal epileptiform discharges (IEDs) on 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 3a of the Project, Comparison of EEG-recordings)
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