TetraplegiaRoBIK-1NCT01005524
Brain Computer Interface for Communication in ICU: a Feasibility Study
An observational study of Tetraplegia and Guillain-Barre Syndrome, run by University of Versailles at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetraplegia, Guillain-Barre Syndrome
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Admitted in the ICU
- Quadriplegic and requiring mechanical ventilation (tracheostomy) 24/24h
Who cannot join
- Acute respiratory failure.
- Visual disorder
- Cognitive disorder
- Illiterate patient
- Mother tongue other than french
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tetraplegia, Guillain-Barre Syndrome
- Keywords
- brain computer interface, P3Speller, P300, Event Related potential, tetraplegia, Guillain barre syndrome, Feasibility, Speed of spelling, Accuracy
- Medical subject headings
- Quadriplegia, Guillain-Barre Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Djillali Annane, University of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005524
- Sponsor's protocol ID
- ANR-TecSan-2009
- Other IDs
- AFM2009
- Acronym
- RoBIK-1
- Status last verified
- May 2012
- First submitted
- 30 Oct 2009
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for Daily Use of a Brain Computer Interface for Communication in an ICU
- ClinicalTrials.gov ID
- NCT01005524
- Acronym / sponsor ID
- RoBIK-1 / ANR-TecSan-2009
- Conditions
- Tetraplegia, Guillain-Barre Syndrome
- Keywords
- brain computer interface, P3Speller, P300, Event Related potential, tetraplegia, Guillain barre syndrome, Feasibility, Speed of spelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Admitted in the ICU
- Quadriplegic and requiring mechanical ventilation (tracheostomy) 24/24h
Key exclusion criteria (5 listed)
- Acute respiratory failure.
- Visual disorder
- Cognitive disorder
- Illiterate patient
- Mother tongue other than french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
- Related InfoLink provided by the sponsor.
- Software used for BCILink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetraplegia and Guillain-Barre Syndrome, run by University of Versailles at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.