Pubertet, testosteron og hjerneudvikling
Effekt af testosteron på hjernebilleddannelse og hovedpine hos transmaskuline unge
Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain.
This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first year of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 3 visits:
- before starting T
- after 6 months on T
- after 1 year on T
At the visits, they will be asked to:
- answer questions and surveys about their health
- have a brain MRI done
- give a small sample of blood
and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months and for 1 month after the 1 year visit.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
This will be conducted at Childrens Hospital Colorado (CHCO) Clinical & Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging, as applicable, by a medical provider.
Visits will be in the morning to capture peak hormone levels.
The following questionnaires will be administered: PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, and PedMIDAS form (headache disability measure).
The daily headache diary is tailored to be brief on days when no headache occurs, and to capture more detail including medications taken and headache and aura characteristics on days a headache does occur.
The medical chart will be reviewed for relevant health information and medications.
MR-based imaging will be conducted at the Brain Imaging Center at the University of Colorado Anschutz Medical Campus.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jennifer Hranilovich, MD
- Telefonnummer: (720)-777-6895
- E-mail: headache-research@childrenscolorado.org
Studiesteder
-
-
Colorado
-
Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- Children's Hospital Colorado
-
Kontakt:
- Jennifer Hranilovich
- Telefonnummer: 720-777-6895
- E-mail: headache-research@childrenscolorado.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
transmasculine and gender diverse youth
Beskrivelse
Inclusion Criteria:
- transmasculine and gender diverse
- assigned female at birth
- age 12-20 years at the time of enrollment
- plan to start testosterone clinically in < 6 months
- if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
Exclusion Criteria:
- cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
- known history of stroke, multiple sclerosis, or other serious neurologic condition
- prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
- prior diagnosis of polycystic ovarian syndrome (PCOS)
- uncontrolled or untreated hypothyroidism
- MRI-specific exclusion criteria: (Weight > 500 lbs, severe claustrophobia, certain type of metal in body)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
On blocker
Transmasculine youth who will begin taking testosterone clinically in < 6 months with or without headache and who have been on pubertal blocker, a gonadotropin hormone releasing (GnRH) agonist for at least 3 months. |
Clinical testosterone therapy No research interventions will be used as a part of the study since the research is observational. Testosterone treatment will be prescribed and followed by participant's clinical physician. |
|
No blocker
Transmasculine youth who will begin taking testosterone clinically in < 6 months with or without headache and who have no history of pubertal blocker. |
Clinical testosterone therapy No research interventions will be used as a part of the study since the research is observational. Testosterone treatment will be prescribed and followed by participant's clinical physician. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in headache burden
Tidsramme: Over the one year of the study
|
Change in number of headache days per month |
Over the one year of the study
|
|
Amygdala volume
Tidsramme: At the end of the one year of study
|
As measured by volumetric MRI |
At the end of the one year of study
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Headache diagnosis
Tidsramme: At baseline visit before start of T
|
Application of ICHD-3 criteria to headaches, if any |
At baseline visit before start of T
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jennifer Hranilovich, Children's Hospital Colorado
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Smerte
- Neurologiske manifestationer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Hovedpinelidelser, Primær
- Hovedpine lidelser
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Migræne lidelser
- Hovedpine
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Polycykliske forbindelser
- Steroider
- SMUSED-RING-forbindelser
- Gonadale steroidhormoner
- Gonadale hormoner
- Androstenes
- Androstanes
- Androstenoler
- Testosteron -kongenere
- Testosteron
Andre undersøgelses-id-numre
- 23-1113
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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