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

Amyotrophic Lateral Sclerosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01897818
• Other study ID #: 12-PP-16
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2013
• Last updated: July 9, 2013
• Start date: July 2013

Study information

• Verified date: May 2013
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Claude DESNUELLE, Pr
• Email: desnuelle.c[@]chu-nice.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Device:
• communication system P300 Speller

Locations

Country	Name	City	State
France	Hôpital de l'Archet I	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the full achievement of "copy spelling" and "free spelling" tests session 1		14 days after inclusion	No
Primary	the full achievement of "copy spelling" and "free spelling" tests session 2		28 days after inclusion	No