Clinical trial NCT03027141: Self-Face Recognition After Face Transplantation
Official title: Pilot Study: Self-Face Recognition After Face Transplantation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Disfigurement of Face
Keywords: Face Transplant
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before disfigurement,
timeFrame: 5 Years
measure: Average percentage of the self in the morphs that participants judge to be "like self" for the self- face before before surgery
timeFrame: 5 Years
measure: Average percentage of the self in the morphs that participants judge to be "like self" for the self- face after surgery.
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eduardo Rodriguez
role: PRINCIPAL_INVESTIGATOR
References: