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

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ClinicalTrials.gov Identifier: NCT01897818
Recruitment Status : Unknown
Verified May 2013 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: communication system P300 Speller Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : July 2013
Estimated Primary Completion Date : July 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: ALS patients Device: communication system P300 Speller


Outcome Measures
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Primary Outcome Measures :
  1. the full achievement of "copy spelling" and "free spelling" tests session 1 [ Time Frame: 14 days after inclusion ]
  2. the full achievement of "copy spelling" and "free spelling" tests session 2 [ Time Frame: 28 days after inclusion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897818


Contacts
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Contact: Claude DESNUELLE, Pr desnuelle.c@chu-nice.fr

Locations
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France
Hôpital de l'Archet I Recruiting
Nice, France, 06202
Contact: Claude DESNUELLE, Pr       desnuelle.c@chu-nice.fr   
Principal Investigator: Claude DESNUELLE, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01897818    
Other Study ID Numbers: 12-PP-16
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: July 12, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases