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Brain development, brain functioning, growth and metabolic aspects in the clinical management of transsexual adolescents.

Brain development, brain functioning, growth and metabolic aspects in the clinical management of transsexual adolescents.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26605
Enrollment
264
Registered
2007-01-10
Start date
2007-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transsexuality according to the DSM IV criteria.

Interventions

Patients: measurements will be performed at a prepubertal stage, before start of GNrH analogue Triptoreline/ Decapeptyl-CR (current puberty delaying medication for transsexual adolescents in the VUmc
2. Functional MRI (BOLD) during which 3 cognition tasks will be performed (mental rotation, verbal fluency and emotional faces)
3. Physical examination with anthropometric measurements and gathering of information about pubertal stage according to Tanner
4. Digital photographs and physical appearance list
5. Salivary testosterone measurements
6. Family pedigree research: homosexuality/ transsexuality in family. The duration of the intervention will be approximately three hours for every visit, which means at maximum 5 visits (if patients

Sponsors

VU university medical center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria pubertal patients: 1. Girls and boys with transsexualism who are eligible for sex reassignment according to psychologist and psychiatrist (If they are older than 12 years, psychologically stable and live in a stable social environment); 2. Girls have to be in stage B2 and boys in G2-G3 with measurable estradiol and testosterone levels respectively; Inclusion criteria pre-pubertal patients: 1. Girls and boys with high probability of transsexualism according to psychologist or psychiatrist and the age of 9-12 years; 2. Girls have to be in an earlier stage than B2 and boys in an earlier stage than G2-G3; Inclusion criteria healthy subjects: 1. Girls and boys who are similar aged friends of the transsexual patients.

Exclusion criteria

Exclusion criteria: Exclusion criteria patients: 1. Intersex conditions; Exclusion criteria healthy subjects: 1. Puberty delaying treatment or hormonal therapy; oral anticonception users are not excluded.

Design outcomes

Primary

MeasureTime frame
1. Cognition: performance and reaction time on three cognition tasks (verbal fluency task, mental rotation task and emotional faces task), reaction times and performance will be measured; 2. Functional MRI: data during the verbal fluency task, mental rotation task and emotional faces task; 3. Structural MRI: data on total brain volume, gray and white matter (amount and percentage), CSF, volume frontal and temporal lobe, gyrification, brain asymmetry. ROI analysis of basal ganglia, amygdala, hippocampus, corpus callosum, hypothalamus.

Secondary

MeasureTime frame
1. Score from -10 to 10 on handedness questionairre; 2. Performance score on adapted WISC-III questionairre (4 items: 2 performance, 2 verbal); 3. Information about psychological functioning (parent questionairre); 4. Anthropometric data, information about pubertal stage according to Tanner; 5. Information about homosexuality/ transsexuality in familymembers; 6. Digital photographs and physical appearance list (14 items).

Contacts

Public ContactF.M. Wouters

VU medical center, Department of Pediatrics, 1Y125 Boelelaan 1117

f.wouters@vumc.nl+31 20-4441035

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)