Clinical Trial: Robust Intelligent Keyboard for Quadraplegic Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Centre d'Investigation Clinique et Technologique 805

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Centre d'Investigation Clinique et Technologique 805

Dates:
Date Received: October 5, 2012
Date Started: February 2013
Date Completion: April 2017
Last Updated: April 28, 2017
Last Verified: April 2017