Brain Computer Interface for Communication in ICU: a Feasibility Study - Full Text View

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

This study is currently recruiting participants.

Verified March 2010 by University of Versailles

First Received on October 30, 2009. Last Updated on March 19, 2010 History of Changes

Sponsor:	University of Versailles
Information provided by:	University of Versailles
ClinicalTrials.gov Identifier:	NCT01005524

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:

Genetics Home Reference related topics: Guillain-Barré syndrome

MedlinePlus related topics: Guillain-Barre Syndrome

U.S. FDA Resources

Further study details as provided by University of Versailles:

Estimated Enrollment:	10
Study Start Date:	January 2010
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Eligibility

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005524

Locations

France
Service de reanimation, Hopital Raymond Poincare	Recruiting
Garches, France, 92380
Contact: David Orlikowski, MD +33147107746
Principal Investigator: David Orlikowski, MD

Sponsors and Collaborators

University of Versailles

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Software used for BCI This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Djillali Annane, University of Versailles UVSQ, Assistance Publique Hôpitaux de Paris APHP
ClinicalTrials.gov Identifier:	NCT01005524 History of Changes
Other Study ID Numbers:	ANR-TecSan-2009, AFM2009
Study First Received:	October 30, 2009
Last Updated:	March 19, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University of Versailles:

brain computer interface
P3Speller
P300
Event Related potential
tetraplegia

Guillain barre syndrome
Feasibility
Speed of spelling
Accuracy

Additional relevant MeSH terms:

Guillain-Barre Syndrome
Quadriplegia
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases

Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012