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.
調査の概要
状態
募集
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
72
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Shawn Bolin, MS
- 電話番号：608-263-6308
- メール：sbolin@wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- 募集
- UW School of Medicine and Public Health
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
他の名前：
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.
他の名前：
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change Cerebral Blood Flow (CBF)
時間枠：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
時間枠：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)
|
|
|
Change in Body Composition
時間枠：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
時間枠：baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
Glucose is a marker of metabolic health
|
baseline and up to 6 months (after 4-6 months of continuous GAHT)
|
|
Change in Insulin
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：William Schrage, PhD、University of Wisconsin, Madison
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月14日
一次修了 (推定)
2028年4月1日
研究の完了 (推定)
2028年4月1日
試験登録日
最初に提出
2026年5月28日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2024-1861
- Protocol Version 1/12/26 (その他の識別子：UW Madison)
- SOE/Kinesiology (その他の識別子：UW Madison)
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個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
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いいえ
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