Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty

N/AActive Not RecruitingNCT05607303

University of Colorado, Denver138 enrolled

Overview

With a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. Transfemale (MTF) youth (male sex, female gender identity) who begin clinical Gender Affirming Hormone Therapy (GAHT) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). This research hopes to learn more about headache in MTF youth.

MTF youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. Cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. The researchers will track how often youth have headaches during this time to see if it is different between groups. In a subset of the youth enrolled, an MRI will be completed to also look at brain structure and function.

Study Type

OBSERVATIONAL

Enrollment

138

Conditions

Headache Gender Identity

Interventions

Clinical estrogen therapyOTHER

No research interventions will be used as a part of the study since the research is observational. Estrogen treatment will be prescribed and followed by participant's clinical physician.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For MTF youth (cases): * Identify as MTF * Age 11-20 years at the time of enrollment * Plan to start estrogen clinically in \< 6 months For cisgender male youth (controls): * Identify as cisgender male * Age 9-20 years at the time of enrollment * No diagnosis of Klinefelter Syndrome (XXY) Exclusion Criteria: * Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety * Known history of stroke, multiple sclerosis, or other serious neurologic condition * MRI-specific exclusion criteria (Weight \> 500 lbs, claustrophobia, metal in body)

Locations (1)

Children's Hospital Colorado

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in frequency of headache.

Measured by headache count from daily headache diary.

Time frame: 1 year

Secondary Outcomes

Change in amygdala structure.

Amygdala volume as measured on MRI.

Time frame: 1 year

Change in resting state functional connectivity pattern.

Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.

Time frame: 1 year

Data from ClinicalTrials.gov

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