NCT04380649

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

Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 BCI's 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.

Conditions

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Spinal Cord Diseases
• Alternative Communication Devices
• Neurodegenerative Diseases
• Nervous System Diseases
• Neuromuscular Diseases

Interventions

Type	Name	Description
DEVICE	New headset prototype	creation of a new headset prototype for using the P300 Speller, comfortable to use in everyday life by people with disabilities.

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-08-12
• Completion: 2026-08-12
• First posted: 2020-05-08
• Last updated: 2025-11-26

Locations

1 site across 1 country: France