Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04380649
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2020-04-22
Brief Title:
Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
TECH-ICOPA
Brief Summary:
Brain-computer interfaces BCIs are computer-based systems that acquire brain signals analyze them and translate them into commands that are relayed to an output device to carry out a desired action BCIs represent a very active and promising field of research among devices for people with severe motor disabilities As the currently available systems correspond to research prototypes they are not adapted to daily live situations On the other hand some systems have recently been commercialized principally for video games but they are not satisfactory for use as a substitute technology in disability
A BCIs prototype for alternative communication using a virtual keyboard the P300 Speller has been developed by the National Institute for Research in Digital Science and Technology Athena team - Nice University This prototype includes an EEG-cap with gel based active electrodes A recent study conducted on 20 patients with ALS University Hospital Nice demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility To achieve a system that can be used in daily live in severely disabled patients technical developments are necessary
The investigators have conceptualized and developed an ergonomic comfortable headset including dry electrodes to allow a prolonged use of the system
The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved This study is a monocentric usability study conducted on ALS people
A BCIs prototype for alternative communication using a virtual keyboard the P300 Speller has been developed by the National Institute for Research in Digital Science and Technology Athena team - Nice University This prototype includes an EEG-cap with gel based active electrodes A recent study conducted on 20 patients with ALS University Hospital Nice demonstrated the usability of the system and the patient satisfaction concerning the ease of use and utility To achieve a system that can be used in daily live in severely disabled patients technical developments are necessary
The investigators have conceptualized and developed an ergonomic comfortable headset including dry electrodes to allow a prolonged use of the system
The purpose of the study conducted all along the development of the headset is to improve the developed system until a successful system is achieved This study is a monocentric usability study conducted on ALS people
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None