Mental HealthMYELEXNCT06868966
Implications of Myelin in Executive Control in Adolescence and Early Adulthood
An observational study of Mental Health, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy adolescent and adult volunteers aged 10 to 25 years with no contraindications for an MRI examination.
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Conditions
- Mental Health
- Medical subject headings
- Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Myelin
Myelin Levels : Regional variations of Fractional Anisotropy (FA)
Measured: Day 1
Secondary outcomes (13)
Working Memory
Spatial Span from CANTAB
- Units on a Scale
Measured: Day 1
Inhibitory skills
Stop Signal Task from CANTAB and CHEXI, TEXI and ADEXI self-questionnaires
- Units on a Scale
Measured: Day 1
Planning skills
One Touch Stockings of Cambridge - Units on a Scale
Measured: Day 1
Decision-making and risk-taking
Cambridge Gambling Task from CANTAB - Units on a Scale
Measured: Day 1
Reading skills
Text, word and pseudoword reading and metaphonology from EVALEO 6-15/ECLA16+/EXALANG - Units on a Scale
Measured: Day 1
IQ
Raven's Standard Progressive Matrices (SPM) - Units on a Scale
Measured: Day 1
Reasoning
Cognitive Reasoning Task - Units on a Scale
Measured: Day 1
Social Cognition
Tom-15 task - Units on a Scale
Measured: Day 1
Visuospatial attention
Multiple Object Tracking task from CRAB - Units on a Scale
Measured: Day 1
Wellbeing questionnaire
KIDSCREEN 27 for minor participants and SF-36 for adults - Units on a Scale
Measured: Day 1
Behavior questionnaire
BIS/BAS scales - Units on a Scale
Measured: Day 1
Self-regulation questionnaire
DERS-F - Units on a Scale
Measured: Day 1
Demographics questionnaire
Age, sex, level of studies, etc.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868966
- Sponsor's protocol ID
- D23-P028
- Acronym
- MYELEX
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Myelin in Executive Control in Adolescence and Early Adulthood
- ClinicalTrials.gov ID
- NCT06868966
- Acronym / sponsor ID
- MYELEX / D23-P028
- Conditions
- Mental Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy adolescent and adult volunteers aged 10 to 25 years with no contraindications for an MRI examination.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myelin
Time frame: Day 1
Myelin Levels : Regional variations of Fractional Anisotropy (FA)
13 secondary outcomes
Working Memory
Time frame: Day 1
Inhibitory skills
Time frame: Day 1
Planning skills
Time frame: Day 1
Decision-making and risk-taking
Time frame: Day 1
Reading skills
Time frame: Day 1
IQ
Time frame: Day 1
Reasoning
Time frame: Day 1
Social Cognition
Time frame: Day 1
Visuospatial attention
Time frame: Day 1
Wellbeing questionnaire
Time frame: Day 1
Behavior questionnaire
Time frame: Day 1
Self-regulation questionnaire
Time frame: Day 1
Demographics questionnaire
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Cachia (06 61 51 92 00 ext. +33, arnaud.cachia@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myelin (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.