Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study

Not Applicable

Not yet recruiting

• Conditions: Cerebrospinal Fluid; Healthy Subjects or Volunteers

• Registration Number: NCT06743347
• Lead Sponsor: Poitiers University Hospital

Brief Summary

This research will enhance our knowledge and understanding of Cerebrospinal Fluid (CSF) circulation around the Central Nervous System (CNS) (brain and spinal cord).

The main objective is to obtain flow velocities using Phase Contrast (PC) MRI over the entire subarachnoid space (SAS). This will enable us to develop and validate a numerical model of the SAS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Study First Posted: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Study Start: 2025-02
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Age ≥ 18 years at the time of agreement
• Free subject, without guardianship or curatorship or subordination
• Patients benefiting from a Social Security scheme or benefiting from it through a third party
• Informed consent signed by the patient after clear and complete information about the study

Exclusion Criteria

• 3T MRI contraindications (pacemaker, cochlear implant, metallic splinter, etc)
• History of neurological pathology
• Previous operations involving the central nervous system (spinal surgery, neurological surgery, etc.)
• Current pathology or treatment that may interfere with the CSF or subarachnoid spaces (CSF dysregulation, disc herniation, hydrocephalus, Chiari malformation, etc.)
• Concurrent participation in another clinical research study
• Persons not covered by Social Security or not covered by Social Security through a third party
• Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
• Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)

Exclusion criteria during the study:

• Discovery of a contraindication to 3T MRI (pacemaker, cochlear implant, metallic splinter, etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the velocity displacement of CSF about 7 planes (intracranial plane, C2-C3, C5-C6, T4-T5, T10-T11, L3-L4, L5-S1)	Time PC-MRI will be around 60min	Displacement velocities of CSF will be obtain by Phase Contrats MRI.

Secondary Outcome Measures

Name	Time	Method
Using morphological MRI to model a digital twin	Time PC-MRI will be around 60min	Comparison of velocity fields for each measurement section plane
To evaluate the velocity displacement of blood about 2 planes (intracranial plane, C2-C3)	Time PC-MRI will be around 60min	Displacement velocities of blood will be obtain by Phase Contrats MRI.