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Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

This study is currently recruiting participants.
Verified October 2012 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Collaborator:
University of Versailles
Information provided by (Responsible Party):
david orlikowski, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01707498
First received: October 5, 2012
Last updated: February 14, 2013
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
- Quadraplegia
 Procedure: Scanning device
Procedure: RoBIK Brain-Computer Interface
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • BIT RATE IN BIT PER MINUTE(bpm) [ Time Frame: 15 MINUTES ] [ Designated as safety issue: No ]
    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) [ Time Frame: 60 mns ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707498

Contacts
Contact: DAVID ORLIKOWSKI, MD PHD david.orlikowski@rpc.aphp.fr

Locations
France
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: DAVID ORLIKOWSKI, MD PHD     (33)147107777     david.orlikowski@rpc.aphp.fr    
Contact: SANDRA POTTIER, CRA     (33)147104469     sandra.pottier@rpc.aphp.fr    
Principal Investigator: DAVID ORLIKOWSKI, MD PHD            
Sub-Investigator: ERIC AZZABOU, MD            
Sub-Investigator: CAROLINE HUGERON, MD            
Sub-Investigator: PHILIPPE TRONCHET, MD            
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
University of Versailles
Investigators
Study Director: LOUIS MAYAUD, ENGINEER CIC IT 805
  More Information

No publications provided

Responsible Party: david orlikowski, PROFESSOR, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01707498     History of Changes
Other Study ID Numbers: 2012-A00613-40
Study First Received: October 5, 2012
Last Updated: February 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
BCI
TETRAPLEGIA
COMMUNICATION
P300
ASSISTIVE TECHNOLOGIE

Additional relevant MeSH terms:
Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013