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Robust Intelligent Keyboard for Quadraplegic Patients (PVCRoBIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01707498
Recruitment Status : Unknown
Verified January 2018 by david orlikowski, Centre d'Investigation Clinique et Technologique 805.
Recruitment status was:  Recruiting
First Posted : October 16, 2012
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
University of Versailles
Information provided by (Responsible Party):
david orlikowski, Centre d'Investigation Clinique et Technologique 805

Study Description
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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.

Condition or disease Intervention/treatment Phase
Quadraplegia Procedure: Scanning device Procedure: RoBIK Brain-Computer Interface Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients
Actual Study Start Date : February 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. BIT RATE IN BIT PER MINUTE(bpm) [ Time Frame: 15 MINUTES ]
    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 :
  1. Installation time (seconds) [ Time Frame: 60 mns ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707498


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

Locations
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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
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Study Director: LOUIS MAYAUD, ENGINEER CIC IT 805
More Information
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Responsible Party: david orlikowski, PROFESSOR, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01707498    
Other Study ID Numbers: 2012-A00613-40
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Keywords provided by david orlikowski, Centre d'Investigation Clinique et Technologique 805:
BCI
TETRAPLEGIA
COMMUNICATION
P300
ASSISTIVE TECHNOLOGIE
Additional relevant MeSH terms:
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Quadriplegia
Paralysis
Neurologic Manifestations
Nervous System Diseases