Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
communication system P300 Speller
Sponsored by
About this trial
This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Hôpital de l'Archet IRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALS patients
Arm Description
Outcomes
Primary Outcome Measures
the full achievement of "copy spelling" and "free spelling" tests session 1
the full achievement of "copy spelling" and "free spelling" tests session 2
Secondary Outcome Measures
Full Information
NCT ID
NCT01897818
First Posted
July 9, 2013
Last Updated
July 9, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01897818
Brief Title
Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALS patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
communication system P300 Speller
Primary Outcome Measure Information:
Title
the full achievement of "copy spelling" and "free spelling" tests session 1
Time Frame
14 days after inclusion
Title
the full achievement of "copy spelling" and "free spelling" tests session 2
Time Frame
28 days after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claude DESNUELLE, Pr
Email
desnuelle.c@chu-nice.fr
Facility Information:
Facility Name
Hôpital de l'Archet I
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude DESNUELLE, Pr
Email
desnuelle.c@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Claude DESNUELLE, Pr
12. IPD Sharing Statement
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Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study
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