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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01897818
First received: July 9, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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 Intervention
Amyotrophic Lateral Sclerosis
Device: communication system P300 Speller

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • the full achievement of "copy spelling" and "free spelling" tests session 1 [ Time Frame: 14 days after inclusion ] [ Designated as safety issue: No ]
  • the full achievement of "copy spelling" and "free spelling" tests session 2 [ Time Frame: 28 days after inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALS patients Device: communication system P300 Speller

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897818

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

Locations
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

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01897818     History of Changes
Other Study ID Numbers: 12-PP-16
Study First Received: July 9, 2013
Last Updated: July 9, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014