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Brain Computer Interface for Communication in ICU: a Feasibility Study (RoBIK-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005524
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : May 23, 2012
Information provided by (Responsible Party):
Djillali Annane, University of Versailles

Brief Summary:
The main objective of this study is to evaluate the usability of a system to assist verbal communication based on BCI system using the P300 wave in patients with tetraplegia who can no longer communicate because of severe engine damage (tetraplegia) and respiratory damage requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal communication.

Condition or disease
Tetraplegia Guillain-Barre Syndrome

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study for Daily Use of a Brain Computer Interface for Communication in an ICU
Study Start Date : January 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Quadriplegia, also known as tetraplegia, is paralysis caused by illness or injury to a human that results in the partial or total loss of use of all of their limbs and torso; paraplegia is similar but does not affect the arms. The loss is usually sensory and motor, which means both sensation and control are lost.

Inclusion Criteria:

  • Admitted in the ICU
  • Quadriplegic and requiring mechanical ventilation (tracheostomy) 24/24h

Exclusion Criteria:

  • Acute respiratory failure.
  • Visual disorder
  • Cognitive disorder
  • Illiterate patient
  • Mother tongue other than french

Information from the National Library of Medicine

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 identifier (NCT number): NCT01005524

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Service de reanimation, Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Additional Information:
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Responsible Party: Djillali Annane, Head of ICU, University of Versailles Identifier: NCT01005524    
Other Study ID Numbers: ANR-TecSan-2009
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Djillali Annane, University of Versailles:
brain computer interface
Event Related potential
Guillain barre syndrome
Speed of spelling
Additional relevant MeSH terms:
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Guillain-Barre Syndrome
Neurologic Manifestations
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases