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

C

Centre Hospitalier Universitaire de Nice

Status

Unknown

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Device: communication system P300 Speller

Study type

Interventional

Funder types

Other

Identifiers

NCT01897818
12-PP-16

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

ALS patients
Experimental group
Treatment:
Device: communication system P300 Speller

Trial contacts and locations

1

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Central trial contact

Claude DESNUELLE, Pr

Data sourced from clinicaltrials.gov

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