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Recruiting NCT04935164

Comparative Study of Gender Identity Disorder Versus Control

Observational Gender Dysphoria, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psychiatric evaluations.
Who it may be relevant to
Registry conditions: Gender Dysphoria, Adult. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Study of Gender Dysphoria Phenomenology and Neurophysiology: Clinical and Experimental Exploration of Gender Identity Disorder

Overview

Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity.

Detailed description

Gender dysphoria is manifested by an internal tension between biological sex and gender, that is, by a non-congruence, in the subjects who suffer from it, between their sex of birth and their social gender identity. Gender dysphoria is accompanied by the often overwhelming need for a hormonal or even hormone-surgical transition. Gender dysphoria is very often characterized by fluctuating mood sadness, irritability, obsessionality. An improvement in the quality of life after medical treatment (hormone therapy) and gender reassignment surgery has been described in the literature. Morphological similarities have been found between the brains of women and the brains of so-called transgender women, as well as between the brains of transgender men and men. These morphological data are only very fragmentary and have not been supported by neuro-functional data. Self-awareness, which refers to the awareness that an individual has of his body, his image and his own identity, is partly underpinned, at the brain level, by the activation of the Default Mode Network (DMN) at rest, in non-pathological conditions. The conflict between the internal perception of the own body and its objective representation could result in a change in brain connectivity within the DMN, due in particular to changes in the activation of the temporo parietal junction.

Interventions

  • Other Psychiatric evaluations
    At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes

Primary outcome measures

  • Contribution of temporal parameters of microstates C, D, E and F [Time frame: Week 1 to Week 24]
  • Duration of temporal parameters of microstates C, D, E and F [Time frame: Week 1 to Week 24]
  • Mean-Global Field Power temporal parameters of microstates C, D, E and F [Time frame: Week 1 to Week 24]
  • Occurrence of temporal parameters of microstates C, D, E and F [Time frame: Week 1 to Week 24]
  • Cortical voxel activity from source reconstruction analysis, using electroencephalogram during Double Mirror Test (D.M.T). [Time frame: Week 1 to Week 24]

Eligibility criteria

Inclusion criteria

  • Patients with gender dysphoria
  • Without psychotropic
  • Without hormono-therapy
  • Without sexual surgery assignation

Exclusion criteria

  • Any depression
  • Any addiction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Centre Hospitalier Henri Laborit — Poitiers

Identifiers

NCT: NCT04935164 · 2020-A03407-32

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗