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Self-Face Recognition After Face Transplantation

Primary Purpose

Disfigurement of Face

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Face recognition task
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disfigurement of Face focused on measuring Face Transplant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have suffered from severe facial disfigurement which warrant facial transplantation and have been evaluated and approved for transplantation, will be included.

Exclusion Criteria:

  • Must be be able to enter and be scanned using MRI.
  • Able to give full informed consent, before each scan and throughout their time in which they are participating in the study
  • Able to perform the task to a high standard and also to have no underlying conditions that may alter how they process pictures of face

  • Participants must have none of the following, which cannot safely be removed without risk or discomfort while they enter the MRI unit:

    • a pacemaker
    • metal implants
    • metal that cannot be removed on their body (e.g. shrapnel, piercings)
    • metal clips
    • an artificial heart valve
    • a cochlear implant
    • drug patches
    • a contraceptive coil
    • dental plates/braces with metal in
    • hearing aids

  • Participants will also be excluded on the grounds of safety and comfort inside the MRI scanner if they have one of the following underlying conditions

    • epilepsy
    • diabetes
    • heart disease
    • thermoregulatory problems (problems regulating body temperature)
    • a possibility of being pregnant
    • currently breastfeeding

  • Participants will also be excluded on the grounds of MRI data quality for the following reasons:

    • history of mental illness
    • claustrophobia (discomfort in confined spaces)
    • Neurological conditions

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pre-Transplant Time Point

Post-Transplant Time Point

Arm Description

Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)

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).

Outcomes

Primary Outcome Measures

Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before disfigurement,
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
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before before surgery
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
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face after surgery.
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

Secondary Outcome Measures

Full Information

First Posted
January 18, 2017
Last Updated
July 25, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03027141
Brief Title
Self-Face Recognition After Face Transplantation
Official Title
Pilot Study: Self-Face Recognition After Face Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disfigurement of Face
Keywords
Face Transplant

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-Transplant Time Point
Arm Type
Active Comparator
Arm Description
Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)
Arm Title
Post-Transplant Time Point
Arm Type
Experimental
Arm 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(s)
Face recognition task
Intervention 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.
Primary Outcome Measure Information:
Title
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before disfigurement,
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
Time Frame
5 Years
Title
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before before surgery
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
Time Frame
5 Years
Title
Average percentage of the self in the morphs that participants judge to be "like self" for the self- face after surgery.
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
Time Frame
5 Years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have suffered from severe facial disfigurement which warrant facial transplantation and have been evaluated and approved for transplantation, will be included. Exclusion Criteria: Must be be able to enter and be scanned using MRI. Able to give full informed consent, before each scan and throughout their time in which they are participating in the study Able to perform the task to a high standard and also to have no underlying conditions that may alter how they process pictures of face Participants must have none of the following, which cannot safely be removed without risk or discomfort while they enter the MRI unit: a pacemaker metal implants metal that cannot be removed on their body (e.g. shrapnel, piercings) metal clips an artificial heart valve a cochlear implant drug patches a contraceptive coil dental plates/braces with metal in hearing aids Participants will also be excluded on the grounds of safety and comfort inside the MRI scanner if they have one of the following underlying conditions epilepsy diabetes heart disease thermoregulatory problems (problems regulating body temperature) a possibility of being pregnant currently breastfeeding Participants will also be excluded on the grounds of MRI data quality for the following reasons: history of mental illness claustrophobia (discomfort in confined spaces) Neurological conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Rodriguez
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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Self-Face Recognition After Face Transplantation

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