Brain Computer Interface for Communication in ICU: a Feasibility Study

NCT ID: NCT01005524

Last Updated: 2012-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tetraplegia Guillain-Barre Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Versailles

OTHER

Sponsor Role lead

Responsible Party

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Djillali Annane

Head of ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Service de reanimation, Hopital Raymond Poincare

Garches, , France

Site Status

Countries

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France

Related Links

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http://openvibe.inria.fr

Software used for BCI

Other Identifiers

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AFM2009

Identifier Type: -

Identifier Source: secondary_id

ANR-TecSan-2009

Identifier Type: -

Identifier Source: org_study_id

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