PVCRoBIK: Robust Intelligent Keyboard for Quadraplegic Patients
Study Details
Study Description
Brief 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. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tetraplegic patients Scanning device RoBIK Brain-Computer Interface |
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 |
Procedure: RoBIK Brain-Computer Interface
Patients will be asked to spell a text with the BCI
|
Outcome Measures
Primary Outcome Measures
- BIT RATE IN BIT PER MINUTE(bpm) [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)
Secondary Outcome Measures
- Installation time (seconds) [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Raymond Poincare | Garches | France | 92380 |
Sponsors and Collaborators
- Centre d'Investigation Clinique et Technologique 805
- University of Versailles
Investigators
- Study Director: LOUIS MAYAUD, ENGINEER, CIC IT 805
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2012-A00613-40