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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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