Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)
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ClinicalTrials.gov Identifier: NCT01707498 |
Recruitment Status : Unknown
Verified January 2018 by david orlikowski, Centre d'Investigation Clinique et Technologique 805.
Recruitment status was: Recruiting
First Posted : October 16, 2012
Last Update Posted : February 1, 2018
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Condition or disease | Intervention/treatment | Phase |
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Quadraplegia | Procedure: Scanning device Procedure: RoBIK Brain-Computer Interface | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients |
Actual Study Start Date : | February 2013 |
Estimated Primary Completion Date : | January 2018 |
Estimated Study Completion Date : | January 2018 |
Arm | Intervention/treatment |
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Experimental: Tetraplegic patients
Scanning device RoBIK Brain-Computer Interface
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Procedure: Scanning device
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. Procedure: RoBIK Brain-Computer Interface Patients will be asked to spell a text with the BCI |
Experimental: Healthy volunteers
RoBIK Brain-Computer Interface
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Procedure: RoBIK Brain-Computer Interface
Patients will be asked to spell a text with the BCI |
- 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)
- Installation time (seconds) [ Time Frame: 60 mns ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy volunteers:
- Informed consent
- Adults aged more than 18yo
- Passed complete medical check-up (heart-rate, blood pressure,...)
- Negative pregnancy test
Quadripleagic patients:
- Informed consent
- Adults aged more than 18years
- Passed medical exam
- Negative pregnancy test
- Full medical checkup
- haemodynamic stability
Exclusion Criteria:
Healthy volunteers:
- history of epilepsy or seizure
- auditory or visual deficit
- 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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707498
Contact: DAVID ORLIKOWSKI, MD PHD | david.orlikowski@rpc.aphp.fr |
France | |
Hopital Raymond Poincare | Recruiting |
Garches, France, 92380 | |
Contact: DAVID ORLIKOWSKI, MD PHD (33)147107777 david.orlikowski@rpc.aphp.fr | |
Contact: SANDRA POTTIER, CRA (33)147104469 sandra.pottier@rpc.aphp.fr | |
Principal Investigator: DAVID ORLIKOWSKI, MD PHD | |
Sub-Investigator: ERIC AZZABOU, MD | |
Sub-Investigator: CAROLINE HUGERON, MD | |
Sub-Investigator: PHILIPPE TRONCHET, MD |
Study Director: | LOUIS MAYAUD, ENGINEER | CIC IT 805 |
Responsible Party: | david orlikowski, PROFESSOR, Centre d'Investigation Clinique et Technologique 805 |
ClinicalTrials.gov Identifier: | NCT01707498 |
Other Study ID Numbers: |
2012-A00613-40 |
First Posted: | October 16, 2012 Key Record Dates |
Last Update Posted: | February 1, 2018 |
Last Verified: | January 2018 |
BCI TETRAPLEGIA COMMUNICATION P300 ASSISTIVE TECHNOLOGIE |
Quadriplegia Paralysis Neurologic Manifestations Nervous System Diseases |