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

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis; Alternative Communication Devices; Nervous System Diseases; Motor Neuron Disease; Spinal Cord Diseases; Neuromuscular Diseases; Neurodegenerative Diseases
• Interventions: Device: New headset prototype

• Registration Number: NCT04380649
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-08
• Study Start: 2023-02-13
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALS people with severe disability	New headset prototype	-

Primary Outcome Measures

Name	Time	Method
Quality of the impedance of each electrode	at 6 months	The quality will be considered satisfactory if the impedance value of each of the electrodes is ≤ 1 000 kOhm, according to literature data.
Patient/caregiver satisfaction	at 6 months	The evaluation of patient and caregiver satisfaction will be carried out using visual analogue scales (VAS rated from 0 to 10) on their feelings (patient/caregiver) of use.
prototype set-up time	at 6 months	The time for setting up the prototype will be defined in seconds by the time elapsed between the start and stop of the stopwatch, the installation sequence being defined as follows: * start of the stopwatch: patient seated, equipment positioned on the table; * patient or caregiver (depending on the patient's motor skills; 1 person): takes the prototype and positions it on the (patient's) skull; * stopwatch stop: when the prototype is set up ready to operate
Number of errors during calibration	at 6 months	The number of errors in copying the 10 letters during the calibration phase will be counted.

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Provence Alpes Cote d'Azur, France