EEG@HOME (Phase 4 of the Project)
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|ClinicalTrials.gov Identifier: NCT02394639|
Recruitment Status : Withdrawn (Project funding ended before reaching Phase 4.)
First Posted : March 20, 2015
Last Update Posted : November 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Other: video-EEG monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||September 2016|
Active Comparator: conventional video-EEG monitoring
conventional video-EEG monitoring with cup-electrodes and collodion
Other: video-EEG monitoring
Experimental: video-EEG monitoring with prototype
video-EEG monitoring of 5 hours with EEG-cap with dry electrodes
Other: video-EEG monitoring
- EEG signal quality (visual and clinical) (scale) [ Time Frame: 5 hours ]
- EEG signal quality (technical) (signal to noise ratio) [ Time Frame: 5 hours ]
- User experience (questionnaire) [ Time Frame: 5 hours ]
- EEG-technologist experience (questionnaire) [ Time Frame: 5 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394639
|University Hospital, Ghent|
|Ghent, Belgium, 9000|
|University Hospital, Leuven|
|Leuven, Belgium, 3000|