<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/NCT03027141</url>
  </required_header>
  <id_info>
    <org_study_id>16-01144</org_study_id>
    <nct_id>NCT03027141</nct_id>
  </id_info>
  <brief_title>Self-Face Recognition After Face Transplantation</brief_title>
  <official_title>Pilot Study: Self-Face Recognition After Face Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed study is to use functional magnetic resonance imaging (fMRI) to&#xD;
      investigate how a change in facial appearance is initially represented in brain circuits and&#xD;
      then alters over time, as the new face becomes recognized as &quot;me&quot;.&#xD;
&#xD;
      Investigators will try to identify areas of the brain responsible for processing and storing&#xD;
      information about self-facial recognition; Examine how these areas of the brain respond to&#xD;
      images of &quot;self&quot; and &quot;non-self&quot; and; Investigate how the brain responds, over time, to&#xD;
      changes in facial recognition, particularly at time points: i) prior to facial injury, ii)&#xD;
      post-injury but prior to facial transplantation, and iii) after receiving facial&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before surgery, investigators will compare activity in the brain when participants are&#xD;
      looking at their pre-injury and their injured face with activity when they are looking at the&#xD;
      persons face with whom they are familiar with. This will identify whether there are&#xD;
      differences between how the brain responds when patients view their current facial appearance&#xD;
      and when viewing their face before facial disfigurement. Investigators will then scan the&#xD;
      patients post-operatively when the transplant team deems the patient ready; this will depend&#xD;
      on reduction of post-operative swelling, improved communication with the treatment team, and&#xD;
      patient psychological status. Activity in the brain will be compared when participants are&#xD;
      looking at pictures of the familiar other person, with pictures of their pre-injury,&#xD;
      pre-transplant disfigured face and pictures of their post-transplant facial appearance.&#xD;
      Participants will be scanned again, at least two months later, with the same set of stimuli.&#xD;
      Activity in the brain will be compared when participants look at their pre-transplant&#xD;
      disfigured face and their new face, compared with activity when they look at the familiar&#xD;
      other. This will allow investigators to see the differences in how the brain responds to the&#xD;
      new facial appearance over time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average percentage of the self in the morphs that participants judge to be &quot;like self&quot; for the self- face before disfigurement,</measure>
    <time_frame>5 Years</time_frame>
    <description>This will be done by means of a series of repeated-measures analyses of variance (ANOVA statistical tests) using a computer program - the Statistical Package for the Social Sciences</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average percentage of the self in the morphs that participants judge to be &quot;like self&quot; for the self- face before before surgery</measure>
    <time_frame>5 Years</time_frame>
    <description>This will be done by means of a series of repeated-measures analyses of variance (ANOVA statistical tests) using a computer program - the Statistical Package for the Social Sciences</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average percentage of the self in the morphs that participants judge to be &quot;like self&quot; for the self- face after surgery.</measure>
    <time_frame>5 Years</time_frame>
    <description>This will be done by means of a series of repeated-measures analyses of variance (ANOVA statistical tests) using a computer program - the Statistical Package for the Social Sciences</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Disfigurement of Face</condition>
  <arm_group>
    <arm_group_label>Pre-Transplant Time Point</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Transplant Time Point</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI). Patients for whom a pre-transplant fMRI was obtained will undergo functional MRI scanning at three-points post-transplant (approximately 2 and 4 months +/- 2 months post-operation and again at 1 year +/- 3 months post-transplant).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Face recognition task</intervention_name>
    <description>Inside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture.</description>
    <arm_group_label>Post-Transplant Time Point</arm_group_label>
    <arm_group_label>Pre-Transplant Time Point</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have suffered from severe facial disfigurement which warrant facial&#xD;
             transplantation and have been evaluated and approved for transplantation, will be&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must be be able to enter and be scanned using MRI.&#xD;
&#xD;
          -  Able to give full informed consent, before each scan and throughout their time in&#xD;
             which they are participating in the study&#xD;
&#xD;
          -  Able to perform the task to a high standard and also to have no underlying conditions&#xD;
             that may alter how they process pictures of face&#xD;
&#xD;
          -  Participants must have none of the following, which cannot safely be removed without&#xD;
             risk or discomfort while they enter the MRI unit:&#xD;
&#xD;
               -  a pacemaker&#xD;
&#xD;
               -  metal implants&#xD;
&#xD;
               -  metal that cannot be removed on their body (e.g. shrapnel, piercings)&#xD;
&#xD;
               -  metal clips&#xD;
&#xD;
               -  an artificial heart valve&#xD;
&#xD;
               -  a cochlear implant&#xD;
&#xD;
               -  drug patches&#xD;
&#xD;
               -  a contraceptive coil&#xD;
&#xD;
               -  dental plates/braces with metal in&#xD;
&#xD;
               -  hearing aids&#xD;
&#xD;
          -  Participants will also be excluded on the grounds of safety and comfort inside the MRI&#xD;
             scanner if they have one of the following underlying conditions&#xD;
&#xD;
               -  epilepsy&#xD;
&#xD;
               -  diabetes&#xD;
&#xD;
               -  heart disease&#xD;
&#xD;
               -  thermoregulatory problems (problems regulating body temperature)&#xD;
&#xD;
               -  a possibility of being pregnant&#xD;
&#xD;
               -  currently breastfeeding&#xD;
&#xD;
          -  Participants will also be excluded on the grounds of MRI data quality for the&#xD;
             following reasons:&#xD;
&#xD;
               -  history of mental illness&#xD;
&#xD;
               -  claustrophobia (discomfort in confined spaces)&#xD;
&#xD;
               -  Neurological conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo Rodriguez</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Face Transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>DiGeorge Syndrome</mesh_term>
    <mesh_term>Facies</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/NCT03027141
org study id: 16-01144
nct id: NCT03027141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed study is to use functional magnetic resonance imaging (fMRI) to
      investigate how a change in facial appearance is initially represented in brain circuits and
      then alters over time, as the new face becomes recognized as "me".

      Investigators will try to identify areas of the brain responsible for processing and storing
      information about self-facial recognition; Examine how these areas of the brain respond to
      images of "self" and "non-self" and; Investigate how the brain responds, over time, to
      changes in facial recognition, particularly at time points: i) prior to facial injury, ii)
      post-injury but prior to facial transplantation, and iii) after receiving facial
      transplantation.
Before surgery, investigators will compare activity in the brain when participants are
      looking at their pre-injury and their injured face with activity when they are looking at the
      persons face with whom they are familiar with. This will identify whether there are
      differences between how the brain responds when patients view their current facial appearance
      and when viewing their face before facial disfigurement. Investigators will then scan the
      patients post-operatively when the transplant team deems the patient ready; this will depend
      on reduction of post-operative swelling, improved communication with the treatment team, and
      patient psychological status. Activity in the brain will be compared when participants are
      looking at pictures of the familiar other person, with pictures of their pre-injury,
      pre-transplant disfigured face and pictures of their post-transplant facial appearance.
      Participants will be scanned again, at least two months later, with the same set of stimuli.
      Activity in the brain will be compared when participants look at their pre-transplant
      disfigured face and their new face, compared with activity when they look at the familiar
      other. This will allow investigators to see the differences in how the brain responds to the
      new facial appearance over time.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before disfigurement,
time frame: 5 Years
description: This will be done by means of a series of repeated-measures analyses of variance (ANOVA statistical tests) using a computer program - the Statistical Package for the Social Sciences
measure: Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before before surgery
time frame: 5 Years
description: This will be done by means of a series of repeated-measures analyses of variance (ANOVA statistical tests) using a computer program - the Statistical Package for the Social Sciences
measure: Average percentage of the self in the morphs that participants judge to be "like self" for the self- face after surgery.
time frame: 5 Years
description: This will be done by means of a series of repeated-measures analyses of variance (ANOVA statistical tests) using a computer program - the Statistical Package for the Social Sciences
arm group label: Pre-Transplant Time Point
arm group type: Active Comparator
description: Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)
arm group label: Post-Transplant Time Point
arm group type: Experimental
description: Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI). Patients for whom a pre-transplant fMRI was obtained will undergo functional MRI scanning at three-points post-transplant (approximately 2 and 4 months +/- 2 months post-operation and again at 1 year +/- 3 months post-transplant).
intervention type: Behavioral
intervention name: Face recognition task
description: Inside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture.
arm group label: Post-Transplant Time Point
arm group label: Pre-Transplant Time Point
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eduardo Rodriguez
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: DiGeorge Syndrome
mesh term: Facies