Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
Study NCT ID:
NCT06868966
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-07-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implications of Myelin in Executive Control in Adolescence and Early Adulthood
Sponsor:
Centre Hospitalier St Anne
Organization:
Study Overview
Official Title:
Implications of Myelin in Executive Control in Adolescence and Early Adulthood
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYELEX
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.
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
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: