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

This study has been completed.
Information provided by (Responsible Party):
Djillali Annane, University of Versailles Identifier:
First received: October 30, 2009
Last updated: May 21, 2012
Last verified: May 2012
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.

Guillain-Barre Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study for Daily Use of a Brain Computer Interface for Communication in an ICU

Resource links provided by NLM:

Further study details as provided by University of Versailles:

Enrollment: 12
Study Start Date: January 2010
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01005524

Service de reanimation, Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
  More Information

Additional Information:
No publications provided

Responsible Party: Djillali Annane, Head of ICU, University of Versailles Identifier: NCT01005524     History of Changes
Other Study ID Numbers: ANR-TecSan-2009, AFM2009
Study First Received: October 30, 2009
Last Updated: May 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Versailles:
brain computer interface
Event Related potential
Guillain barre syndrome
Speed of spelling

Additional relevant MeSH terms:
Guillain-Barre Syndrome
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms processed this record on December 01, 2015