Robust Intelligent Keyboard for Quadraplegic Patients

Centre d'Investigation Clinique et Technologique 80520 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Quadraplegia

Interventions

Scanning devicePROCEDURE

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

Patients will be asked to spell a text with the BCI

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hopital Raymond Poincare

Garches, France

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 15 MINUTES

Secondary Outcomes

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.

Time frame: 60 mns

Central Contacts

DAVID ORLIKOWSKI, MD PHD

CONTACT

david.orlikowski@rpc.aphp.fr

Data from ClinicalTrials.gov

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