Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 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: January 28, 2014
Last verified: January 2014
  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:


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 2014
Estimated Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 28, 2014
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 July 09, 2014