Gender Identity and Own Body Perception

Gender Identity and Own Body Perception- Implications for the Neurobiology of Gender Dysphoria

This study will provide valuable information on the neurobiological underpinning of gender dysphoria (GD) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment.

Study Overview

• Status: Terminated
• Conditions: Gender Dysphoria
• Intervention / Treatment: Diagnostic test: fMRI

Detailed Description

The purpose of this study is to understand the neurobiology of gender dysphoria (GD) and the interactions between cross hormone treatment, the brain, and the body phenotype. The investigators also aim to identify pre-treatment neurobiological and other factors to help predict body congruence and quality of life outcomes from hormone treatment. There is mounting interest in gender identity issues worldwide, as requests for gender-confirming treatments have increased in the past 3 decades, and alarmingly high suicide rates have recently been reported in those with GD. Despite this, little is known about neurobiological or other etiological factors contributing to GD or gender incongruence. This study will address a core feature of GD that has been little studied in terms of the neurobiology: the incongruence between perception of self and one's own body.

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll 150 participants between the ages of 18 and 40 (25 trans males; 25 trans females; 25 cis gender females; 25 cis gender males; 25 homosexual males; 25 homosexual females)

Description

Participants with gender dysphoria (GD)

Inclusion Criteria:

• Females and males from any racial or ethnic background, between the ages of 18 years and 40 years.
• Participants must meet Diagnostic and Statistical Manual-5 criteria for GD (302.85)
• Intelligence quotient (IQ) > 80

Participants with GD

Exclusion Criteria:

• Previous or on-going sex hormone medication
• Previous sex reassignment surgery
• Oral contraceptives
• Participants with GD are not be taking any other psychotropic medication. (No participant will be recommended to discontinue or taper medications for the purpose of participating in the study.)
• Irregular menstrual cycles

Control participants

Inclusion Criteria:

• Females and males from any racial or ethnic background, between the ages of 18 and 40.
• IQ > 80

Control participants

Exclusion Criteria:

• Psychiatric medications
• A score of ≥ 1 standard deviation higher than population norms on the MADRS depression or the Hamilton anxiety scale (HAMA)
• Sex hormone treatment
• Irregular menstrual cycles

Exclusion criteria for all participants:

• Any known chromosomal or hormonal disorder
• Current substance abuse or dependence
• Current neurological disorder or psychiatric disorder
• Pregnancy
• Current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
• Head trauma associated with loss of consciousness
• HIV positive individuals
• Individuals with ferromagnetic metal implantations or devices. This includes any electronic implants or devices, braces, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates
• Visual acuity worse than 20/35 for each eye as determined by Snellen close vision acuity chart. Acuity may be met with corrective lenses

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trans men; fMRI: body morph test and neurocognitive testing	Diagnostic test: fMRI; fMRI: body morph test and neurocognitive testing
trans women; fMRI: body morph test and neurocognitive testing	Diagnostic test: fMRI; fMRI: body morph test and neurocognitive testing
homosexual cisgender men; fMRI: body morph test and neurocognitive testing	Diagnostic test: fMRI; fMRI: body morph test and neurocognitive testing
homosexual cisgender women; fMRI: body morph test and neurocognitive testing	Diagnostic test: fMRI; fMRI: body morph test and neurocognitive testing
cisgender women; fMRI: body morph test and neurocognitive testing	Diagnostic test: fMRI; fMRI: body morph test and neurocognitive testing
cisgender men; fMRI: body morph test and neurocognitive testing	Diagnostic test: fMRI; fMRI: body morph test and neurocognitive testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence	Own body perception in relation to functional and structural connection	Baseline Visit 2 pre hormone treatment
Morphometric differences by sex, gender identity and sexual orientation	Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.	Baseline Visit 2 pre hormone treatment
Brain activation during own body perception	Images of body morph test presented during fMRI scan	Baseline Visit 2 pre hormone treatment
Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence	Own body perception in relation to functional and structural connection	Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Change in morphometric differences by sex, gender identity and sexual orientation	Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.	Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Change in brain activation during own body perception	Images of body morph test presented during fMRI scan	Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: 1R01HD087712-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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