Robust Intelligent Keyboard for Quadraplegic Patients

Not Applicable

• Conditions: Quadraplegia
• Interventions: Procedure: Scanning device; Procedure: RoBIK Brain-Computer Interface

• Registration Number: NCT01707498
• Lead Sponsor: Centre d'Investigation Clinique et Technologique 805

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 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 Timeline

• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-14
• Study First Posted: 2012-10-16
• Study Start: 2013-02
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tetraplegic patients	Scanning device	Scanning device RoBIK Brain-Computer Interface
Healthy volunteers	RoBIK Brain-Computer Interface	RoBIK Brain-Computer Interface
Tetraplegic patients	RoBIK Brain-Computer Interface	Scanning device RoBIK Brain-Computer Interface

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France