Comparative Study of Gender Identity Disorder Versus Control (TRANSIDENT)

June 3, 2025 updated by: Centre Hospitalier Henri Laborit

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Week 1 to Week 24
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
Time Frame: Week 1 to Week 24
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
Week 1 to Week 24
Occurrence of temporal parameters of microstates C, D, E and F
Time Frame: Week 1 to Week 24
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
Week 1 to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Henri Laborit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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