NCT04380649Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
"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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 22 Apr 2020
- Start date
- 13 Feb 2023
- Primary completion date
- 12 Aug 2024
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04380649
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 13 Feb 2023 to the primary completion date, 12 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
- History of photosensitive epilepsy
Other
- Patient subject to protective measures
- Non-correctable visual disturbances
- Limited ability to concentrate.
- Women who are pregnant or breastfeeding or who have planned a pregnancy during the course of the study.
- Persons deprived of their liberty by a judicial or administrative decision
Who the study is looking for
- Age ≥ 18 years old
- For women of childbearing potential, use of contraception for the duration of the study
- Diagnosis of suspected ALS, possible, probable with ENMG, probable, defined according to the criteria of the World Federation of Neurology (revised El Escorial criteria, Airlie House Conference 1998)
- Understanding of the objective of the study after describing the principle of the P300 Speller and the course of the study
- Ability to follow the study procedure and to comply with the schedule of visits when entering the study
- Expression of a P300 wave under the conditions of the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.