Brain Health in Transgender Adults
2026年5月28日 更新者：University of Wisconsin, Madison
Cerebral Blood Flow and Neurocognitive Performance in Adults Undergoing Gender-affirming Hormone Therapy
The purpose of this study is to test whether and how a person's brain changes in the first few months after starting gender affirming hormone therapy (GAHT).
The investigators want to know if GAHT changes: 1) cerebral blood flow (CBF), 2) brain structure, connectivity, and cognitive task performance, and 3) neurocognitive function (memory, attention, executive function, processing speed).
36 male at birth and 36 female at birth participants will conduct baseline studies prior to GAHT, with a second identical set of study visits 4-6 months after GAHT begins.
研究概览
地位
招聘中
条件
详细说明
The purpose of this study is to assess the effects of GAHT on cerebral structure and function. To this end, this study has three aims:
Aim 1: To identify if transgender males and females demonstrate changes in
- A) basal CBF and
- B) CBF responses to acute stress-particularly in areas involved in cognition, memory, and learning.
Aim 2: To identify if transgender adults will demonstrate significant changes in:
- A) overall brain structure,
- B) functional connectivity, and
- C) task activation.
Aim 3: To identify if neurocognitive function changes in transgender adults.
The investigators hypothesize that:
- Aim 1: Transgender females will demonstrate increased basal CBF and larger CBF responses to acute stress, particularly in areas involved in cognition, memory, and learning, whereas transgender males will display lower basal CBF and lower CBF responses to acute stress.
- Aim 2: Transgender patients will demonstrate significant changes in: a) overall brain structure, b) functional connectivity, and c) task activation.
- Aim 3: Neurocognitive function will increase in transgender females and decreases in transgender males, primarily in the domains of memory, attention, executive function, and processing speed.
研究类型
观察性的
注册 (估计的)
72
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shawn Bolin, MS
- 电话号码：608-263-6308
- 邮箱：sbolin@wisc.edu
学习地点
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- 招聘中
- UW School of Medicine and Public Health
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
描述
Inclusion Criteria:
- intention to undergo GAHT
Exclusion Criteria:
- BMI greater than 40 kg/m2
- Age greater than 45 yrs
- Blood pressure greater than 140/90 (stage II hypertension)
- A current diagnosis of type II diabetes
- History of traumatic brain injury/concussion, stroke, or seizures
- Are post-menopausal
- Previously taken hormone therapy medications
- Self-reported pregnancy (no pregnancy test)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Male at birth undergoing GAHT with their Clinical Care Team
|
Two MRI visits (baseline and after 4-6 months of continuous GAHT) will involve structural scans of the brain, scans while performing cognitive tasks, and a scan taken while responding to an inhaled CO2 stressor.
This visit will take approximately 1.5 hours.
其他名称：
Two cognition and health test trials (baseline and after 4-6 months of continuous GAHT) will involve a body composition scan to determine body fat percentage, muscle mass, and bone density.
This will be followed by a set of cognitive tasks using the NIH Toolbox.
Optional graded exercise test will be performed if the participant consents to this optional procedure (baseline and after 4-6months of continuous GAHT).
to determine cardiorespiratory fitness.
This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry.
|
|
Female at birth undergoing GAHT with their Clinical Care Team
|
Two MRI visits (baseline and after 4-6 months of continuous GAHT) will involve structural scans of the brain, scans while performing cognitive tasks, and a scan taken while responding to an inhaled CO2 stressor.
This visit will take approximately 1.5 hours.
其他名称：
Two cognition and health test trials (baseline and after 4-6 months of continuous GAHT) will involve a body composition scan to determine body fat percentage, muscle mass, and bone density.
This will be followed by a set of cognitive tasks using the NIH Toolbox.
Optional graded exercise test will be performed if the participant consents to this optional procedure (baseline and after 4-6months of continuous GAHT).
to determine cardiorespiratory fitness.
This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
CBF at rest and in response to cognitive stressors.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Brain Structure
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Grey matter and White matter volumes.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Brain Connectivity
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Measured using MRI.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: Flanker Inhibitory Control and Attention
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
NIH Toolbox to assess neurocognitive function.
The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: Pattern Comparison Processing Speed Test
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
NIH Toolbox to assess neurocognitive function.
The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds.
There is a maximum of 130 items.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: List Sorting Working Memory Test
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
NIH Toolbox to assess neurocognitive function.
The List Sorting Working Memory Test is a measure of recall and sorting.
Participants scores reflect the number of items recalled and appropriately sorted up to 28 items maximum.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: Dimensional Change Card Sort Test
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
NIH Toolbox to assess neurocognitive function.
The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cognitive Function: Picture Vocabulary Test
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
NIH Toolbox to assess neurocognitive function.
The Picture Vocabulary Test has the participant hear a word and then pick from one of four pictures that best represents the word.
It is scored using a T-score where 100 is the average, higher scores indicate better performance.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Changes in CBF in response to inhaled mixture of room air and CO2
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Changes in sex steroid concentrations
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
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Change in Body Composition
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Dual-energy X-ray absorptiometry (DEXA)
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Blood Glucose
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Glucose is a marker of metabolic health
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baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Insulin
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Insulin is a marker of metabolic health.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Cytokines
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Cytokines are a marker of inflammation.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Optional Graded Exercise Test: VO2 Max
大体时间：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
An optional graded exercise test will be performed to determine cardiorespiratory fitness.
This test will be performed on a cycle ergometer, with a metabolic allowing for the measurement of maximal oxygen consumption via indirect calorimetry.
This will be a ramped exercise test, starting at a wattage of 50W and increasing in difficulty by 1 watt every 2 seconds.
The purpose of this is to begin at a low intensity and gradually increase the difficulty until exhaustion is reached.
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：William Schrage, PhD、University of Wisconsin, Madison
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年10月14日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2028年4月1日
研究注册日期
首次提交
2026年5月28日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.