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临床试验/NCT04374708
NCT04374708终止不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2018年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
132
试验地点
1
主要终点
Morphometric differences by sex, gender identity and sexual orientation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • 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

结局指标

主要结局

Morphometric differences by sex, gender identity and sexual orientation

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline Visit 2 pre hormone treatment

Own body perception in relation to functional and structural connection

Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence

时间窗: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Own body perception in relation to functional and structural connection

Change in morphometric differences by sex, gender identity and sexual orientation

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie Feusner

Professor of Psychiatry and Biobehavioral Sciences

University of California, Los Angeles

研究点 (1)

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