Skip to main content
Clinical Trials/NCT04380649
NCT04380649
Active, not recruiting
Not Applicable

Brain Computer Interface Prototype Development for Assisted Alternative Communication in ALS

Centre Hospitalier Universitaire de Nice1 site in 1 country5 target enrollmentFebruary 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
5
Locations
1
Primary Endpoint
Quality of the impedance of each electrode
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2023
End Date
August 12, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Quality of the impedance of each electrode

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: at 6 months

The number of errors in copying the 10 letters during the calibration phase will be counted.

Study Sites (1)

Loading locations...

Similar Trials