Gender Identity and Own Body Perception

NCT ID: NCT04374708

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-22

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Gender Dysphoria

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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trans men

fMRI: body morph test and neurocognitive testing

fMRI

Intervention Type DIAGNOSTIC_TEST

fMRI: body morph test and neurocognitive testing

trans women

fMRI: body morph test and neurocognitive testing

fMRI

Intervention Type DIAGNOSTIC_TEST

fMRI: body morph test and neurocognitive testing

homosexual cisgender men

fMRI: body morph test and neurocognitive testing

fMRI

Intervention Type DIAGNOSTIC_TEST

fMRI: body morph test and neurocognitive testing

homosexual cisgender women

fMRI: body morph test and neurocognitive testing

fMRI

Intervention Type DIAGNOSTIC_TEST

fMRI: body morph test and neurocognitive testing

cisgender women

fMRI: body morph test and neurocognitive testing

fMRI

Intervention Type DIAGNOSTIC_TEST

fMRI: body morph test and neurocognitive testing

cisgender men

fMRI: body morph test and neurocognitive testing

fMRI

Intervention Type DIAGNOSTIC_TEST

fMRI: body morph test and neurocognitive testing

Interventions

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fMRI

fMRI: body morph test and neurocognitive testing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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


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

Control participants

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


* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Jamie Feusner

Professor of Psychiatry and Biobehavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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1R01HD087712-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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