<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01707498</url>
  </required_header>
  <id_info>
    <org_study_id>2012-A00613-40</org_study_id>
    <nct_id>NCT01707498</nct_id>
  </id_info>
  <brief_title>Robust Intelligent Keyboard for Quadraplegic Patients</brief_title>
  <acronym>PVCRoBIK</acronym>
  <official_title>Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Versailles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is multi-center prospective randomized trial evaluating the effectiveness of a new&#xD;
      brain-computer interface for communication of quadriplegic patients in a clinical context.&#xD;
      This performance of this will compared to traditional assistive technology (scanning system)&#xD;
      and to performance of a healthy volunteer population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The evaluation aims to estimate the performance of BCIs in patient and healthy subjects in a&#xD;
      clinical setting (primary objective) and to compare this performance with an existing&#xD;
      assitive technology adapted to the target population of this study (scanning system). A&#xD;
      quadriplegic patient population (n = 10) evaluated the two techniques and a population of&#xD;
      healthy subjects (n = 10) evaluated the BCI only.&#xD;
&#xD;
      When a subject meets all the eligibility criteria and is not discarded by any non-inclusion&#xD;
      criteria, he is included in the study. The order of the two techniques to be compared is&#xD;
      randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2013</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BIT RATE IN BIT PER MINUTE(bpm)</measure>
    <time_frame>15 MINUTES</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Installation time (seconds)</measure>
    <time_frame>60 mns</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Quadraplegia</condition>
  <arm_group>
    <arm_group_label>Tetraplegic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scanning device RoBIK Brain-Computer Interface</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RoBIK Brain-Computer Interface</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scanning device</intervention_name>
    <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.</description>
    <arm_group_label>Tetraplegic patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RoBIK Brain-Computer Interface</intervention_name>
    <description>Patients will be asked to spell a text with the BCI</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Tetraplegic patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Adults aged more than 18yo&#xD;
&#xD;
          -  Passed complete medical check-up (heart-rate, blood pressure,...)&#xD;
&#xD;
          -  Negative pregnancy test&#xD;
&#xD;
        Quadripleagic patients:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Adults aged more than 18years&#xD;
&#xD;
          -  Passed medical exam&#xD;
&#xD;
          -  Negative pregnancy test&#xD;
&#xD;
          -  Full medical checkup&#xD;
&#xD;
          -  haemodynamic stability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy volunteers:&#xD;
&#xD;
          -  history of epilepsy or seizure&#xD;
&#xD;
          -  auditory or visual deficit&#xD;
&#xD;
          -  atopic scalp dermatitis&#xD;
&#xD;
          -  hypersensitivity to gold&#xD;
&#xD;
          -  curator/guardianship/under protection of judicial authority&#xD;
&#xD;
          -  unable to understand the information note and/or to cooperate&#xD;
&#xD;
          -  no social security&#xD;
&#xD;
          -  can't read&#xD;
&#xD;
        Quadripleagic patients:&#xD;
&#xD;
          -  history of epilepsy or seizure&#xD;
&#xD;
          -  auditory or visual deficit&#xD;
&#xD;
          -  cerebral lesion&#xD;
&#xD;
          -  atopic scalp dermatitis&#xD;
&#xD;
          -  hypersensitivity to gold&#xD;
&#xD;
          -  curator/guardianship/under protection of judicial authority&#xD;
&#xD;
          -  unable to understand the information note and/or to cooperate&#xD;
&#xD;
          -  no social security&#xD;
&#xD;
          -  can't read&#xD;
&#xD;
          -  included in a different clinical trial with exclusion period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LOUIS MAYAUD, ENGINEER</last_name>
    <role>Study Director</role>
    <affiliation>CIC IT 805</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>DAVID ORLIKOWSKI, MD PHD</last_name>
    <email>david.orlikowski@rpc.aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hopital Raymond Poincare</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>DAVID ORLIKOWSKI, MD PHD</last_name>
      <phone>(33)147107777</phone>
      <email>david.orlikowski@rpc.aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>SANDRA POTTIER, CRA</last_name>
      <phone>(33)147104469</phone>
      <email>sandra.pottier@rpc.aphp.fr</email>
    </contact_backup>
    <investigator>
      <last_name>DAVID ORLIKOWSKI, MD PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>ERIC AZZABOU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>CAROLINE HUGERON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>PHILIPPE TRONCHET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre d'Investigation Clinique et Technologique 805</investigator_affiliation>
    <investigator_full_name>david orlikowski</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>BCI</keyword>
  <keyword>TETRAPLEGIA</keyword>
  <keyword>COMMUNICATION</keyword>
  <keyword>P300</keyword>
  <keyword>ASSISTIVE TECHNOLOGIE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Quadriplegia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01707498
org study id: 2012-A00613-40
nct id: NCT01707498
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: BIT RATE IN BIT PER MINUTE(bpm)
time frame: 15 MINUTES
description: 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)
measure: Installation time (seconds)
time frame: 60 mns
description: 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.
arm group label: Tetraplegic patients
arm group type: Experimental
description: Scanning device RoBIK Brain-Computer Interface
arm group label: Healthy volunteers
arm group type: Experimental
description: RoBIK Brain-Computer Interface
intervention type: Procedure
intervention name: Scanning device
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.
arm group label: Tetraplegic patients
intervention type: Procedure
intervention name: RoBIK Brain-Computer Interface
description: Patients will be asked to spell a text with the BCI
arm group label: Healthy volunteers
arm group label: Tetraplegic patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: LOUIS MAYAUD, ENGINEER
role: Study Director
affiliation: CIC IT 805
last name: DAVID ORLIKOWSKI, MD PHD
email: david.orlikowski@rpc.aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre d'Investigation Clinique et Technologique 805
investigator full name: david orlikowski
investigator title: PROFESSOR
mesh term: Quadriplegia