Informations générales (source: ClinicalTrials.gov)
Implications of Myelin in Executive Control in Adolescence and Early Adulthood (MYELEX)
Observational
Centre Hospitalier St Anne (Voir sur ClinicalTrials)
juillet 2024
juillet 2028
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GHU PARIS PSY ET NEUROSCIENCES | Arnaud Cachia | Contact (sur clinicalTrials) | |||
Critères
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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).
- 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).
- 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