Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02394639
Status:
WITHDRAWN
Last Update Posted:
2017-11-28
First Post:
2015-02-10
Brief Title:
EEGHOME Phase 4 of the Project
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project funding ended before reaching Phase 4
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None