Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-20 @ 1:46 PM
Study NCT ID:
NCT02408666
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EEG@HOME (Phase 1 of the Project)
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-12
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 (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 Phase 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.
Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed.
The results of the interviews will be analysed by the design company pilipili nv.
In Phase 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, EEG registrations, daily life, ... . In addition EEG-technologists and neurologists will be interviewed about their experience with EEG registrations and what features their dream EEG-cap would have. The purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.
Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50 EEG-technologists or neurologists will be interviewed.
The results of the interviews will be analysed by the design company pilipili nv.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: