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Brain Health in Transgender Adults

28 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

72

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Shawn Bolin, MS
  • Numéro de téléphone: 608-263-6308
  • E-mail: sbolin@wisc.edu

Lieux d'étude

  • États-Unis
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53792
        • Recrutement
        • UW School of Medicine and Public Health

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Adults (18-45 years) undergoing gender affirming hormone therapy with their clinical health care team.

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Male at birth undergoing GAHT with their Clinical Care Team
Dispositif: Magnetic Resonance Imaging
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.
Autres noms:
  • IRM
Autre: Cognition and Health Tests
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.
Autre: Optional Exercise Test
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
Dispositif: Magnetic Resonance Imaging
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.
Autres noms:
  • IRM
Autre: Cognition and Health Tests
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.
Autre: Optional Exercise Test
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change Cerebral Blood Flow (CBF)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change Cerebral Blood Flow (CBF)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Wisconsin, Madison

Les enquêteurs

  • Chercheur principal: William Schrage, PhD, University of Wisconsin, Madison

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

14 octobre 2025

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

28 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2024-1861
  • Protocol Version 1/12/26 (Autre identifiant: UW Madison)
  • SOE/Kinesiology (Autre identifiant: UW Madison)

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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