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| Name | Class |
|---|---|
| University of Versailles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetraplegic patients | Experimental | Scanning device RoBIK Brain-Computer Interface |
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| Healthy volunteers | Experimental | RoBIK Brain-Computer Interface |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scanning device | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 15 MINUTES |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 mns |
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Inclusion Criteria:
Healthy volunteers:
Quadripleagic patients:
Exclusion Criteria:
Healthy volunteers:
Quadripleagic patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAVID ORLIKOWSKI, MD PHD | Contact | david.orlikowski@rpc.aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| LOUIS MAYAUD, ENGINEER | CIC IT 805 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Raymond Poincare | Recruiting | Garches | 92380 | France |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D003142 | Communication |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| RoBIK Brain-Computer Interface | Procedure | Patients will be asked to spell a text with the BCI |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |