Gender Identity and Own Body Perception

Terminated

• Conditions: Gender Dysphoria
• Interventions: Diagnostic Test: fMRI

• Registration Number: NCT04374708
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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.

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 Timeline

• Study Start: 2018-02-22
• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-05
• Primary Completion: 2021-02-01
• Study Completion: 2021-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 132

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cisgender men	fMRI	fMRI: body morph test and neurocognitive testing
trans men	fMRI	fMRI: body morph test and neurocognitive testing
homosexual cisgender men	fMRI	fMRI: body morph test and neurocognitive testing
cisgender women	fMRI	fMRI: body morph test and neurocognitive testing
homosexual cisgender women	fMRI	fMRI: body morph test and neurocognitive testing
trans women	fMRI	fMRI: body morph test and neurocognitive testing

Primary Outcome Measures

Name	Time	Method
Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence	Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.	Own body perception in relation to functional and structural connection
Morphometric differences by sex, gender identity and sexual orientation	Baseline Visit 2 pre hormone treatment	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.
Change in brain activation during own body perception	Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.	Images of body morph test presented during fMRI scan
Brain activation during own body perception	Baseline Visit 2 pre hormone treatment	Images of body morph test presented during fMRI scan
cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence	Baseline Visit 2 pre hormone treatment	Own body perception in relation to functional and structural connection
Change in morphometric differences by sex, gender identity and sexual orientation	Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.	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.

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States