Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02408627
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2015-03-31
Brief Title:
EEGHOME Phase 3a of the Project Comparison of EEG-recordings
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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
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
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
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