Self-Face Recognition After Face Transplantation

Pilot Study: Self-Face Recognition After Face Transplantation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Disfigurement of Face
• Intervention / Treatment: Behavioral: Face recognition task

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-Transplant Time Point; Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI)	Behavioral: Face recognition task; Inside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture.
Experimental: Post-Transplant Time Point; 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).	Behavioral: Face recognition task; Inside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 Years
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	5 Years
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	5 Years

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Eduardo Rodriguez, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimated): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Face Transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Lymphatic Diseases; Endocrine System Diseases; Disease Attributes; Congenital Abnormalities; Genetic Diseases, Inborn; Musculoskeletal Diseases; Parathyroid Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Abnormalities, Multiple; Chromosome Disorders; 22q11 Deletion Syndrome; Lymphatic Abnormalities; Hypoparathyroidism; Facies; DiGeorge Syndrome
• Other Study ID Numbers: 16-01144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No