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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005524
First Posted: November 2, 2009
Last Update Posted: May 23, 2012
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.
Information provided by (Responsible Party):
Djillali Annane, University of Versailles
  Purpose
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
Tetraplegia 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 Djillali Annane, 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)
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: October 30, 2009
First Posted: November 2, 2009
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