Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Device: communication system P300 Speller

• Registration Number: NCT01897818
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-07
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-12
• Last Update Posted: 2013-07-12
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age >= 18
• have a diagnosis of ALS suspected, possible, probable with EMG
• be able to follow the study process and to comply with the schedule of visits upon entry into the study
• understand the purpose of the study
• expressing P300 wave in the conditions of the study

Exclusion Criteria

• have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
• have a significant history of photosensitive epilepsy
• have a history of allergy to the gel used for the electrodes
• Major protected by law (guardianship, curators)
• have uncorrectable visual disorders
• not being able to maintain a sitting position and focus on a computer screen for more than 30 min.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALS patients	communication system P300 Speller	-

Primary Outcome Measures

Name	Time	Method
the full achievement of "copy spelling" and "free spelling" tests session 1	14 days after inclusion
the full achievement of "copy spelling" and "free spelling" tests session 2	28 days after inclusion

Trial Locations

Locations (1)

Hôpital de l'Archet I; 🇫🇷 Nice, France