Comparative Study of Gender Identity Disorder Versus Control (TRANSIDENT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria, Adult
• Intervention / Treatment: Other: Psychiatric evaluations

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Bérangère Thirioux, PhD; Phone Number: 0033 5 49 44 58 56; Email: berangere.thirioux@ch-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86021
    • Recruiting
    • Centre Hospitalier Henri Laborit
    • Contact: Bérangère Thirioux, PhD; Email: berangere.thirioux@ch-poitiers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Contact sponsor for more details

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any depression
• Any addiction

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Male patients with gender dysphoria; male patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation; patients without psychotropic treatments; patients who do not benefit of hormone therapy; patients who have not yet received gender reassignment surgery; patients aged 18 to 60 years; patients with normal or corrected vision; patients without mental defect; patients without neurological impairment	Other: Psychiatric evaluations; At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes; Other Names: Electroencephalography; Double Mirror Test; Mini International Neuropsychiatric Interview; Montgomery-Åsberg Depression Rating Scale; Hamilton Rating Scale for Depression
Female patients with gender dysphoria; female patients with gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation; patients without psychotropic treatments; patients who do not benefit of hormone therapy; patients who have not yet received gender reassignment surgery; patients aged 18 to 60 years; patients with normal or corrected vision; patients without mental defect; patients without neurological impairment	Other: Psychiatric evaluations; At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes; Other Names: Electroencephalography; Double Mirror Test; Mini International Neuropsychiatric Interview; Montgomery-Åsberg Depression Rating Scale; Hamilton Rating Scale for Depression
Male volunteers without gender dysphoria; male volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation; volunteer aged 18 to 60 years; volunteer with normal or corrected vision; volunteer without mental defect; volunteer without neurological impairment	Other: Psychiatric evaluations; At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes; Other Names: Electroencephalography; Double Mirror Test; Mini International Neuropsychiatric Interview; Montgomery-Åsberg Depression Rating Scale; Hamilton Rating Scale for Depression
Female volunteers without gender dysphoria; female volunteer without gender dysphoria according to DSM-V criteria (axis I), confirmed by MINI evaluation; volunteer aged 18 to 60 years; volunteer with normal or corrected vision; volunteer without mental defect; volunteer without neurological impairment	Other: Psychiatric evaluations; At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes; Other Names: Electroencephalography; Double Mirror Test; Mini International Neuropsychiatric Interview; Montgomery-Åsberg Depression Rating Scale; Hamilton Rating Scale for Depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contribution of temporal parameters of microstates C, D, E and F	The proportion of the total time spent in microstates of class 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
Mean-Global Field Power temporal parameters of microstates C, D, E and F		Week 1 to Week 24
Occurrence 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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2021
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: 2020-A03407-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No