Comparative Study of Gender Identity Disorder Versus Control

Recruiting

• Conditions: Gender Dysphoria, Adult

• Registration Number: NCT04935164
• Lead Sponsor: Centre Hospitalier Henri Laborit

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.

Study Timeline

• Study First Submitted: 2021-02-26
• Study Start: 2021-03-26
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-05
• Primary Completion: 2029-03
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• Any depression
• Any addiction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of temporal parameters of microstates C, D, E and F	Week 1 to Week 24
Contribution of temporal parameters of microstates C, D, E and F	Week 1 to Week 24	The proportion of the total time spent in microstates of class C,D,E and F
Mean-Global Field Power temporal parameters of microstates C, D, E and F	Week 1 to Week 24
Duration of temporal parameters of microstates C, D, E and F	Week 1 to Week 24
Cortical voxel activity from source reconstruction analysis, using electroencephalogram during Double Mirror Test (D.M.T).	Week 1 to Week 24

Trial Locations

Locations (1)

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France