QuadraplegiaPVCRoBIKNCT01707498
Robust Intelligent Keyboard for Quadraplegic Patients
A study testing Scanning device and RoBIK Brain-Computer Interface in people with Quadraplegia, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quadraplegia
- What is being tested?
- Scanning device and RoBIK Brain-Computer Interface
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jan 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Informed consent
- Adults aged more than 18yo
- Passed complete medical check-up (heart-rate, blood pressure,...)
- Negative pregnancy test
- Quadripleagic patients:
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- Informed consent
- Adults aged more than 18years
- Passed medical exam
- Negative pregnancy test
- Full medical checkup
- haemodynamic stability
Who cannot join
- Healthy volunteers:
- history of epilepsy or seizure
- auditory or visual deficit
- atopic scalp dermatitis
- hypersensitivity to gold
- curator/guardianship/under protection of judicial authority
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- unable to understand the information note and/or to cooperate
- no social security
- can't read
- Quadripleagic patients:
- history of epilepsy or seizure
- auditory or visual deficit
- cerebral lesion
- atopic scalp dermatitis
- hypersensitivity to gold
- curator/guardianship/under protection of judicial authority
- unable to understand the information note and/or to cooperate
- no social security
- can't read
- included in a different clinical trial with exclusion period
Trial locations and contacts
1 site in 1 country.
DAVID ORLIKOWSKI, MD PHD contact
France1 site, 1 recruiting
- Recruiting
Hopital Raymond Poincare
Garches, 92380
DAVID ORLIKOWSKI, MD PHD, (33)147107777, david.orlikowski@rpc.aphp.fr
SANDRA POTTIER, CRA, (33)147104469, sandra.pottier@rpc.aphp.fr
About this study
Official title: Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.
Read the detailed description
The evaluation aims to estimate the performance of BCIs in patient and healthy subjects in a clinical setting (primary objective) and to compare this performance with an existing assitive technology adapted to the target population of this study (scanning system). A quadriplegic patient population (n = 10) evaluated the two techniques and a population of healthy subjects (n = 10) evaluated the BCI only.
When a subject meets all the eligibility criteria and is not discarded by any non-inclusion criteria, he is included in the study. The order of the two techniques to be compared is randomized.
- Conditions
- Quadraplegia
- Being tested
- Scanning device, RoBIK Brain-Computer Interface
- Keywords
- BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE
- Medical subject headings
- Quadriplegia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning deviceProcedure or surgery
Patients will be asked to spell a text with a specific scanning device. The most appropriate contactor or clicking device will be chosen by a senior therapist.
RoBIK Brain-Computer InterfaceProcedure or surgery
Patients will be asked to spell a text with the BCI
| Study group | Role | What they receive |
|---|---|---|
| Tetraplegic patients | Experimental | Scanning device RoBIK Brain-Computer Interface Receives: Procedure: Scanning device; Procedure: RoBIK Brain-Computer Interface |
| Healthy volunteers | Experimental | RoBIK Brain-Computer Interface Receives: Procedure: RoBIK Brain-Computer Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIT RATE IN BIT PER MINUTE(bpm)
Bitrate (bpm): transfer of information from patient to computer in bits per minutes. This is a reference measurement to compare P300 speller Brain Computer Interfaces. It uses: number of choices on the interface (N), the average time to select one key (t) and the error rate (e)
Measured: 15 MINUTES
Secondary outcomes (1)
Installation time (seconds)
Installation time (seconds), Number of caracters spelt in a pre-defined time, Error rate: Area Under the Receiver Operating Curve (AUROC), Balanced Error Rate (BER), Visual Analogous Scale for tiredness (before, after the use) and overall satisfaction.
Measured: 60 mns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QuadraplegiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- University of Versailles
- Responsible party
- Principal investigator, david orlikowski, Centre d'Investigation Clinique et Technologique 805
- Investigators
- LOUIS MAYAUD, ENGINEER, Study director, CIC IT 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707498
- Sponsor's protocol ID
- 2012-A00613-40
- Acronym
- PVCRoBIK
- Status last verified
- Jan 2018
- First submitted
- 5 Oct 2012
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
- ClinicalTrials.gov ID
- NCT01707498
- Acronym / sponsor ID
- PVCRoBIK / 2012-A00613-40
- Conditions
- Quadraplegia
- Keywords
- BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- University of Versailles
- Study start
- Feb 2013 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 16 Oct 2012 (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.
This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.
Detailed description
The evaluation aims to estimate the performance of BCIs in patient and healthy subjects in a clinical setting (primary objective) and to compare this performance with an existing assitive technology adapted to the target population of this study (scanning system). A quadriplegic patient population (n = 10) evaluated the two techniques and a population of healthy subjects (n = 10) evaluated the BCI only.
When a subject meets all the eligibility criteria and is not discarded by any non-inclusion criteria, he is included in the study. The order of the two techniques to be compared is randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetraplegic patients | Experimental | Procedure: Scanning device, Procedure: RoBIK Brain-Computer InterfaceScanning device RoBIK Brain-Computer Interface |
| Healthy volunteers | Experimental | Procedure: RoBIK Brain-Computer InterfaceRoBIK Brain-Computer Interface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Informed consent
- Adults aged more than 18yo
- Passed complete medical check-up (heart-rate, blood pressure,...)
- Negative pregnancy test
- Informed consent
Key exclusion criteria (20 listed)
- history of epilepsy or seizure
- auditory or visual deficit
- atopic scalp dermatitis
- hypersensitivity to gold
- curator/guardianship/under protection of judicial authority
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scanning devicePatients will be asked to spell a text with a specific scanning device. The most appropriate contactor or clicking device will be chosen by a senior therapist. | Procedure or surgery | Tetraplegic patients |
| RoBIK Brain-Computer InterfacePatients will be asked to spell a text with the BCI | Procedure or surgery | Healthy volunteers, Tetraplegic patients |
Primary outcome
BIT RATE IN BIT PER MINUTE(bpm)
Time frame: 15 MINUTES
Bitrate (bpm): transfer of information from patient to computer in bits per minutes. This is a reference measurement to compare P300 speller Brain Computer Interfaces. It uses: number of choices on the interface (N), the average time to select one key (t) and the error rate (e)
1 secondary outcome
Installation time (seconds)
Time frame: 60 mns
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
DAVID ORLIKOWSKI, MD PHD contact
LOUIS MAYAUD, ENGINEER study director
CIC IT 805
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanning device and RoBIK Brain-Computer Interface in people with Quadraplegia, run by Centre d'Investigation Clinique et Technologique 805 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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAVID ORLIKOWSKI, MD PHD (david.orlikowski@rpc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIT RATE IN BIT PER MINUTE(bpm) (time frame: 15 MINUTES). It is what the study was designed to measure, not a finding.
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 1 Feb 2018.