Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

This study is currently recruiting participants.
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

October 5, 2012
January 28, 2014
February 2013
May 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01707498 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Robust Intelligent Keyboard for Quadraplegic Patients
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
- Quadraplegia
  • 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: Tetraplegic patients
    Scanning device RoBIK Brain-Computer Interface
    Interventions:
    • Procedure: Scanning device
    • Procedure: RoBIK Brain-Computer Interface
  • Experimental: Healthy volunteers
    RoBIK Brain-Computer Interface
    Intervention: Procedure: RoBIK Brain-Computer Interface
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
September 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: DAVID ORLIKOWSKI, MD PHD david.orlikowski@rpc.aphp.fr
France
 
NCT01707498
2012-A00613-40
Yes
david orlikowski, Centre d'Investigation Clinique et Technologique 805
Centre d'Investigation Clinique et Technologique 805
University of Versailles
Study Director: LOUIS MAYAUD, ENGINEER CIC IT 805
Centre d'Investigation Clinique et Technologique 805
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP