NCT01707498

Robust Intelligent Keyboard for Quadraplegic Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre d'Investigation Clinique et Technologique 805 · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Quadraplegia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-02-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2012-10-16
• Last updated: 2018-02-01

Locations

1 site across 1 country: France