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

May 21, 2012 updated by: Djillali Annane, University of Versailles

A Feasibility Study for Daily Use of a Brain Computer Interface for Communication in an ICU

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Service de reanimation, Hopital Raymond Poincare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Versailles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 21, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANR-TecSan-2009
  • AFM2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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