Gender Identity and Own Body Perception

Sponsor
University of California, Los Angeles (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04374708
Collaborator
(none)
150
1
31.8
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Gender Identity and Own Body Perception- Implications for the Neurobiology of Gender Dysphoria
Actual Study Start Date :
Jan 6, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

  3. Brain activation during own body perception [Baseline Visit 2 pre hormone treatment]

    Images of body morph test presented during fMRI scan

  4. 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

  5. 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.

  6. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLA Los Angeles California United States 90095

Sponsors and Collaborators

  • University of California, Los Angeles

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jamie Feusner, Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT04374708
Other Study ID Numbers:
  • 1R01HD087712-01A1
First Posted:
May 5, 2020
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2021