Status:
ACTIVE_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
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 acti...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- Psychiatric illness or dementia that may interfere with the patient's ability to follow study procedures
- History of photosensitive epilepsy
- 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
Exclusion
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04380649
Start Date
February 13 2023
End Date
August 12 2026
Last Update
November 26 2025
Active Locations (1)
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1
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, France, 06000