Gender Dysphoria Clinical Trial
Official title:
Neuroactive Sex Steroids And Their Influence In Glutamatergic Neurotransmission - Effects in Memory and Cognition in Transgender People
Transgender women (male-to-female) were invited to participate in this study to test the
impact of Cross-Sex Hormone Therapy (CSHT) in the brain.
Neuroimaging and cognitive assessment were performed in different time-points to compare the
impact of CSHT in the brain.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 30, 2019 |
Est. primary completion date | March 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Transgender women - Age 18 to 60 years old. Exclusion Criteria: - Use of psychostimulant drugs - Use of Antidepressive, Mood Stabiliser, Anti-psychotic, Benzodiazepines, anti-convulsivants, Anorexigenic - Endocrinological disease (other than diabetes) - Arterial Hypertensive Disease of Diabetes Mellitus out of control target - Neurological disease, including stroke or recent cranial trauma with loss or consciousness - HIV with low CD4 or high viral charge or symptomatic AIDS - Neoplasia |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre |
Brazil,
Salgado JV, Malloy-Diniz LF, Abrantes SS, Moreira L, Schlottfeldt CG, Guimarães W, Freitas DM, Oliveira J, Fuentes D. Applicability of the Rey auditory-verbal learning test to an adult sample in Brazil. Rev Bras Psiquiatr. 2011 Sep;33(3):234-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glutamate concentration in the left hippocampus | Proton Spectroscopy - magnetic resonance imaging; Glutamate concentration in the left hippocampus will be primarily correlated to working memory scores. |
90 days | |
Secondary | Cortical Thickness | Anatomical magnetic resonance imaging | 90 days | |
Secondary | Diffusion track imaging | Micro-Structural magnetic resonance imaging | 90 days | |
Secondary | functional connectivity | functional magnetic resonance imaging | 90 days | |
Secondary | Glutamate concentration in the anterior cingulate cortex and left dorsolateral prefrontal cortex | Proton spectroscopy - magnetic resonance imaging; Glutamate concentration in the left dorsolateral prefrontal cortex will be correlated to over all measures of cognition and executive functioning. | 90 days | |
Secondary | Cognition | Instrument: Wechsler Adult Intelligence Scale (WAIS) version 3. Subscale: Full Scale Intelligence coefficient. Mean: 100 Standard deviation (SD):15 for Brazilian population. Range of classification: 69 and below - Extremely Low 70-79 - Borderline 80-89 - Low Average 90-109 - Average 110-119 - High Average 120-129 - Superior 130 and above - very superior | 90 days | |
Secondary | Operational memory | Subscale from Wechsler Adult Intelligence Scale (WAIS) version 3. Mean: 100 Standard deviation (SD):15 for Brazilian population. 69 and below - Extremely Low 70-79 - Borderline 80-89 - Low Average 90-109 - Average 110-119 - High Average 120-129 - Superior 130 and above - very superior | 90 days | |
Secondary | Verbal memory | Rey Auditory-Verbal Learning Test (RAVLT). Mean and range for Brazilian population: A1 (Verbal Memory - Immediate recall). Range (in Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected A5 (Verbal Memory - immediate recall). Range (in Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected A7 (Verbal Memory - late recall). Range in (Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected Learning Over Trial (LOT) (Learning capacity). Range (in Z-scores): Z <-1.5 are classified as deficit; Z >-1.5 are expected (please, note the reference for Brazilian population in the section "references" where the mean and standard deviation according to Brazilian population are described for each of the subtest; Salgado et al. (2011). |
90 days | |
Secondary | Language (Verbal Fluency) | Verbal Fluency Tests: (FAS) and Animals. Mean and standard deviation (SD) according to age range and years of education: Age range for the test: 16-59 years Score classification according to years of education: From 0 to 8 years of education: Mean: 38.8 SD: 12.0 From 9 to 12 years of education: Mean: 40.5 SD: 10.7 From 12 to 21 years of education: Mean: 44.7 SD:11.2 Range in Z-scores: Z <-1.5 are classified as deficit; Z >-1.5 are expected |
90 days | |
Secondary | Executive function | Stroop Test -Victoria Version. Mean and standard deviation (SD) according to the age range and years of education: For 19-39 years old + 5-8 years of education: Mean: 33.3 SD:11.35 For 19-39 years old + 9 or more years of education: Mean: 41.73 SD: 9.85 For 40-59 years old + 5-8 years of education: Mean: 28 SD: 7.76 For 40-59 years old + 9 or more years of education: Mean: 37.17 SD: 9.98 Range in Z-scores: Z <-1.5 are classified as deficit; Z >-1.5 are expected |
90 days |
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