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

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ClinicalTrials.gov Identifier: NCT01005524
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : May 23, 2012
Sponsor:
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

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01005524


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

Additional Information:
Responsible Party: Djillali Annane, Head of ICU, University of Versailles
ClinicalTrials.gov Identifier: NCT01005524     History of Changes
Other Study ID Numbers: ANR-TecSan-2009
AFM2009
First Posted: November 2, 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
P3Speller
P300
Event Related potential
tetraplegia
Guillain barre syndrome
Feasibility
Speed of spelling
Accuracy

Additional relevant MeSH terms:
Quadriplegia
Guillain-Barre Syndrome
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases