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Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

Primary Purpose

Quadraplegia

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Scanning device

RoBIK Brain-Computer Interface

About this trial

This is an interventional other trial for Quadraplegia focused on measuring BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hopital Raymond PoincareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tetraplegic patients

Healthy volunteers

Arm Description

Scanning device RoBIK Brain-Computer Interface

RoBIK Brain-Computer Interface

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01707498

First Posted

October 5, 2012

Last Updated

January 31, 2018

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

University of Versailles

1. Study Identification

Unique Protocol Identification Number

NCT01707498

Brief Title

Robust Intelligent Keyboard for Quadraplegic Patients

Acronym

PVCRoBIK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (Actual)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

University of Versailles

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Quadraplegia

Keywords

BCI, TETRAPLEGIA, COMMUNICATION, P300, ASSISTIVE TECHNOLOGIE

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tetraplegic patients

Arm Type

Experimental

Arm Description

Scanning device RoBIK Brain-Computer Interface

Arm Title

Healthy volunteers

Arm Type

Experimental

Arm Description

RoBIK Brain-Computer Interface

Intervention Type

Procedure

Intervention Name(s)

Scanning device

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

RoBIK Brain-Computer Interface

Intervention Description

Patients will be asked to spell a text with the BCI

Primary Outcome Measure Information:

Title

BIT RATE IN BIT PER MINUTE(bpm)

Description

Time Frame

15 MINUTES

Secondary Outcome Measure Information:

Title

Installation time (seconds)

Description

Time Frame

60 mns

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DAVID ORLIKOWSKI, MD PHD

david.orlikowski@rpc.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LOUIS MAYAUD, ENGINEER

Organizational Affiliation

CIC IT 805

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Raymond Poincare

City

Garches

ZIP/Postal Code

92380

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DAVID ORLIKOWSKI, MD PHD

Phone

(33)147107777

david.orlikowski@rpc.aphp.fr

First Name & Middle Initial & Last Name & Degree

SANDRA POTTIER, CRA

Phone

(33)147104469

sandra.pottier@rpc.aphp.fr

First Name & Middle Initial & Last Name & Degree

DAVID ORLIKOWSKI, MD PHD

First Name & Middle Initial & Last Name & Degree

ERIC AZZABOU, MD

First Name & Middle Initial & Last Name & Degree

CAROLINE HUGERON, MD

First Name & Middle Initial & Last Name & Degree

PHILIPPE TRONCHET, MD

12. IPD Sharing Statement

Learn more about this trial

Robust Intelligent Keyboard for Quadraplegic Patients

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