Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Change in frequency of headache.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Cases
MTF youth who will begin taking estrogen clinically in < 6 months with or without headache
干预措施: Clinical estrogen therapy (Other)
Controls
Cisgender males with or without headache
结局指标
主要结局
Change in frequency of headache.
时间窗: 1 year
Measured by headache count from daily headache diary.
次要结局
- Change in amygdala structure.(1 year)
- Change in resting state functional connectivity pattern.(1 year)