NCT06868966 Implications of Myelin in Executive Control in Adolescence and Early Adulthood
| NCT ID | NCT06868966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Mental Health |
| Study Type | OBSERVATIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 128 participants in total. It began in 2024-07-12 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06868966 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 25 Years, studying Mental Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06868966 currently recruiting?
Yes, NCT06868966 is actively recruiting participants. Contact the research team at arnaud.cachia@u-paris.fr for enrollment information.
Where is the NCT06868966 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06868966 clinical trial?
NCT06868966 is sponsored by Centre Hospitalier St Anne. The trial plans to enroll 128 participants.