Disfigurement of FaceNCT03027141
Self-Face Recognition After Face Transplantation
A study testing Face recognition task in people with Disfigurement of Face, run by NYU Langone Health at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disfigurement of Face
- What is being tested?
- Face recognition task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have suffered from severe facial disfigurement which warrant facial transplantation and have been evaluated and approved for transplantation, will be included.
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Disfigurement of Face
- Being tested
- Face recognition task
- Keywords
- Face Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face recognition taskBehavioural
Inside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Transplant Time Point | Active comparator | Participants will be imaged in the Magnetic Resonance Imaging scanner (MRI) Receives: Behavioral: Face recognition task |
| Post-Transplant Time Point | Experimental | 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). Receives: Behavioral: Face recognition task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disfigurement of FaceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Rodriguez, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027141
- Sponsor's protocol ID
- 16-01144
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2017
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Azevedo RT, Diaz-Siso JR, Alfonso AR, Ramly EP, Kantar RS, Berman ZP, Diep GK, Rifkin WJ, Rodriguez ED, Tsakiris M. Re-cognizing the new self: The neurocognitive plasticity of self-processing following facial transplantation. Proc Natl Acad Sci U S A. 2023 Apr 4;120(14):e2211966120. doi: 10.1073/pnas.2211966120. Epub 2023 Mar 27.
PubMed 36972456
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Self-Face Recognition After Face Transplantation
- ClinicalTrials.gov ID
- NCT03027141
- Acronym / sponsor ID
- 16-01144
- Conditions
- Disfigurement of Face
- Keywords
- Face Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Transplant Time Point | Active comparator | Behavioral: Face recognition taskParticipants will be imaged in the Magnetic Resonance Imaging scanner (MRI) |
| Post-Transplant Time Point | Experimental | Behavioral: Face recognition taskParticipants 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have suffered from severe facial disfigurement which warrant facial transplantation and have been evaluated and approved for transplantation, will be included.
Key exclusion criteria (25 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face recognition taskInside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture. | Behavioural | Post-Transplant Time Point, Pre-Transplant Time Point |
Primary outcome
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
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
Time frame: 5 Years
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.
Time frame: 5 Years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Results publication: PubMed 36972456Azevedo RT, Diaz-Siso JR, Alfonso AR, Ramly EP, Kantar RS, Berman ZP, Diep GK, Rifkin WJ, Rodriguez ED, Tsakiris M. Re-cognizing the new self: The neurocognitive plasticity of self-processing following facial transplantation. Proc Natl Acad Sci U S A. 2023 Apr 4;120(14):e2211966120. doi: 10.1073/pnas.2211966120. Epub 2023 Mar 27.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Rodriguez principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face recognition task in people with Disfigurement of Face, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.