Implications of Myelin in Executive Control in Adolescence and Early Adulthood (MYELEX)

August 25, 2025 updated by: Centre Hospitalier St Anne
The Myelex study is a fundamental research study that aims to better understand how the brain functions and develops. The objective of this study is to better understand the role of myelin, a sheath that surrounds nerve fibers and determines the speed of information propagation in the brain, in cognitive functioning during development in adolescents and young adults. investigator use Magnetic Resonance Imaging (MRI) because this method allows us to study the anatomy and functioning of the brain in a non-invasive (no injection) and painless manner. investigator focus on cognitive control, a set of cognitive functions in the prefrontal cortex, at the front of the brain, that enable the use of the best strategies on a case-by-case basis to solve problems effectively. These functions are closely associated with academic and professional success and develop late, continuing until early adulthood. The goal of this project is simple: to measure the myelin of nerve fibers using MRI and to evaluate the link with the development of cognitive control. Each participant will undergo an MRI examination and cognitive assessments. The study takes place at the Clinical Research Center of GHU Paris and lasts a total of 3.5 hours, including reception, setup, MRI recording, and the completion of a series of cognitive tasks.

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.

Detailed Description

Selection visit

  • Call for participants for pre-selection
  • Sending of information forms by mail
  • Making an appointment for the inclusion visit Inclusion visit at GHU Paris.
  • Information on the modalities, constraints and foreseeable risks of the study
  • Collection of informed consent
  • Verification of inclusion/non-inclusion criteria

  • Clinical examination: o Verification of medical history and drug treatments

    • Psychiatric pathology in first-degree relatives
    • Consumption of toxic substances (nicotine, alcohol, cannabis, etc.)
    • Manual lateralization will be assessed by the score on the Edinburgh questionnaire (Oldfield, 1971)
    • Blood sample to measure pubertal hormones (testosterone, estradiol and progesterone levels)
  • Collection of main medical history and concomitant treatments
  • Explanation of study procedures
  • MRI examination
  • Cognitive assessment

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.
128

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

  • France
      • Paris, France, 75013
        • Recruiting
        • GHU Ste Anne
        • Contact:
          • Arnaud Cachia

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy adolescent and adult volunteers aged 10 to 25 years with no contraindications for an MRI examination.

Description

Inclusion Criteria:

  • Male or female; Subject aged 10 to 25 years; Right-handed preference; Subject, or legal representative, who has given consent to participate; Native language: French; Subject affiliated with a social security system; Having signed their consent to participate (and their legal representative if applicable), subjects and parents have read the information letter and given their free and informed consent. In cases where only one parent gives consent (for minors), this must be justified (such as no contact with the other parent for over a year).

Exclusion Criteria:

  • Not corresponding to the targeted age range;
  • Subject with contraindications to an MRI examination (pacemaker or neurosensory stimulator or implantable defibrillator, cochlear implants, ferromagnetic foreign bodies in the eyes or brain near neural structures, metal prostheses, patient agitation: non-cooperative or agitated patients, minors, claustrophobic subjects, pregnant women, ventriculoperitoneal neurosurgical shunt valves, dental braces);
  • Subject with chronic alcohol or drug use;
  • Abuse or dependence on substances (except nicotine) or toxic substances for more than 5 years or having led to comas (overdoses);
  • Subject with sudden-onset cognitive disorders that could indicate a stroke; a history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
  • Subject with chronic neurological, psychiatric, endocrine, hepatic, or infectious conditions;
  • Subject with a history of major illness (diabetes, chronic lung disease, severe cardiac, metabolic, hematological, endocrine, or immunological disorder, cancer);
  • Subject on medication: taking medications likely to interfere with brain imaging measurements (psychotropics, anxiolytic hypnotics, neuroleptics, anti-Parkinsonians, benzodiazepines, steroidal anti-inflammatories, antiepileptics, central analgesics, and muscle relaxants);
  • Color blindness;
  • Inability to comply with the study for geographical or psychiatric reasons;
  • Tattoo incompatible with MRI;
  • Cerebral palsy;
  • Fine motor skills disorder;
  • Pregnant women at the time of inclusion;
  • Adult subjects under legal protection or unable to give consent (article L.1121-8 of the French Public Health Code) (under guardianship or curatorship);
  • Children and parents under legal protection measures

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

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
Myelin
Time Frame: Day 1
Myelin Levels : Regional variations of Fractional Anisotropy (FA)
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working Memory
Time Frame: Day 1

Spatial Span from CANTAB

- Units on a Scale
Day 1
Inhibitory skills
Time Frame: Day 1

Stop Signal Task from CANTAB and CHEXI, TEXI and ADEXI self-questionnaires

- Units on a Scale
Day 1
Planning skills
Time Frame: Day 1
One Touch Stockings of Cambridge - Units on a Scale
Day 1
Decision-making and risk-taking
Time Frame: Day 1
Cambridge Gambling Task from CANTAB - Units on a Scale
Day 1
Reading skills
Time Frame: Day 1
Text, word and pseudoword reading and metaphonology from EVALEO 6-15/ECLA16+/EXALANG - Units on a Scale
Day 1
IQ
Time Frame: Day 1
Raven's Standard Progressive Matrices (SPM) - Units on a Scale
Day 1
Reasoning
Time Frame: Day 1
Cognitive Reasoning Task - Units on a Scale
Day 1
Social Cognition
Time Frame: Day 1
Tom-15 task - Units on a Scale
Day 1
Visuospatial attention
Time Frame: Day 1
Multiple Object Tracking task from CRAB - Units on a Scale
Day 1
Wellbeing questionnaire
Time Frame: Day 1
KIDSCREEN 27 for minor participants and SF-36 for adults - Units on a Scale
Day 1
Behavior questionnaire
Time Frame: Day 1
BIS/BAS scales - Units on a Scale
Day 1
Self-regulation questionnaire
Time Frame: Day 1
DERS-F - Units on a Scale
Day 1
Demographics questionnaire
Time Frame: Day 1
Age, sex, level of studies, etc.
Day 1

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 St Anne

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.
July 12, 2024

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.
July 1, 2028

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.
July 1, 2028

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).
July 11, 2024

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.
March 7, 2025

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.
March 11, 2025

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.
September 2, 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.
August 25, 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.
August 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.
  • D23-P028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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