Clinical trial NCT04935164: Comparative Study of Gender Identity Disorder Versus Control
Official title: Comparative Study of Gender Dysphoria Phenomenology and Neurophysiology: Clinical and Experimental Exploration of Gender Identity Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Dysphoria, Adult
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Contact sponsor for more details

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Any depression
* Any addiction

Primary outcomes:
measure: Contribution of temporal parameters of microstates C, D, E and F
timeFrame: Week 1 to Week 24
measure: Duration of temporal parameters of microstates C, D, E and F
timeFrame: Week 1 to Week 24
measure: Mean-Global Field Power temporal parameters of microstates C, D, E and F
timeFrame: Week 1 to Week 24
measure: Occurrence of temporal parameters of microstates C, D, E and F
timeFrame: Week 1 to Week 24
measure: Cortical voxel activity from source reconstruction analysis, using electroencephalogram during Double Mirror Test (D.M.T).
timeFrame: Week 1 to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
References: