Robust Intelligent Keyboard for Quadraplegic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients

Conditions
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Quadraplegia

Intervention / Treatment
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* Procedure: Scanning device
* Procedure: RoBIK Brain-Computer Interface


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tetraplegic patients<br>Scanning device RoBIK Brain-Computer Interface | Procedure: Scanning device<br>* 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.<br>Procedure: RoBIK Brain-Computer Interface<br>* Patients will be asked to spell a text with the BCI<br>|
| Experimental: Healthy volunteers<br>RoBIK Brain-Computer Interface | Procedure: RoBIK Brain-Computer Interface<br>* Patients will be asked to spell a text with the BCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TETRAPLEGIA, BCI, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE