Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

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

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.

Study Overview

• Status: Unknown
• Conditions: Quadraplegia
• Intervention / Treatment: Procedure: Scanning device; Procedure: RoBIK Brain-Computer Interface

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DAVID ORLIKOWSKI, MD PHD; Email: david.orlikowski@rpc.aphp.fr

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Hôpital Raymond Poincaré
    • Contact: DAVID ORLIKOWSKI, MD PHD; Phone Number: (33)147107777; Email: david.orlikowski@rpc.aphp.fr
    • Principal Investigator: DAVID ORLIKOWSKI, MD PHD
    • Contact: SANDRA POTTIER, CRA; Phone Number: (33)147104469; Email: sandra.pottier@rpc.aphp.fr
    • Sub-Investigator: ERIC AZZABOU, MD
    • Sub-Investigator: CAROLINE HUGERON, MD
    • Sub-Investigator: PHILIPPE TRONCHET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Collaborators: University of Versailles
• Investigators: Study Director: LOUIS MAYAUD, ENGINEER, CIC IT 805

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 14, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: P300; BCI; TETRAPLEGIA; COMMUNICATION; ASSISTIVE TECHNOLOGIE
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Quadriplegia
• Other Study ID Numbers: 2012-A00613-40