Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cases MTF youth who will begin taking estrogen clinically in < 6 months with or without headache |
Other: Clinical estrogen therapy
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.
|
| Controls Cisgender males with or without headache |
Outcome Measures
Primary Outcome Measures
- Change in frequency of headache. [1 year]
Measured by headache count from daily headache diary.
Secondary Outcome Measures
- Change in amygdala structure. [1 year]
Amygdala volume as measured on MRI.
- Change in resting state functional connectivity pattern. [1 year]
Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.
Eligibility Criteria
Criteria
Inclusion Criteria:
For MTF youth (cases):
-
Identify as MTF
-
Age 11-20 years at the time of enrollment
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Plan to start estrogen clinically in < 6 months
For cisgender male youth (controls):
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Identify as cisgender male
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Age 11-20 years at the time of enrollment
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No diagnosis of Klinefelter Syndrome (XXY)
Exclusion Criteria:
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Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety
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Known history of stroke, multiple sclerosis, or other serious neurologic condition
-
MRI-specific exclusion criteria (Weight > 500 lbs, claustrophobia, metal in body)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- University of Colorado, Denver
Investigators
- Principal Investigator: Jennifer Hranilovich, MD, Children's Hospital Colorado
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-1824