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NCT01005524 Clinical Trial

Brain Computer Interface for Communication in ICU: a Feasibility Study

Tetraplegia Clinical Trial

— RoBIK-1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01005524
Other study ID # ANR-TecSan-2009
Secondary ID AFM2009
Status Completed
Phase N/A
First received October 30, 2009
Last updated May 21, 2012
Start date January 2010
Est. completion date May 2012

Study information
Verified date May 2012
Source University of Versailles
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date May 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de reanimation, Hopital Raymond Poincare Garches

Sponsors (1)
Lead Sponsor Collaborator
University of Versailles

Country where clinical trial is conducted

France, 

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