Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study

NCT06743347 | Completed

• 1 other identifier: 2024-A02411-46
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrospinal Fluid; Healthy Subjects or Volunteers

Outcome Measures

Primary Outcomes (1)

• To evaluate the velocity displacement of CSF about 7 planes (intracranial plane, C2-C3, C5-C6, T4-T5, T10-T11, L3-L4, L5-S1)

  Displacement velocities of CSF will be obtain by Phase Contrats MRI.

  Time PC-MRI will be around 60min

Secondary Outcomes (2)

• Using morphological MRI to model a digital twin

  Time PC-MRI will be around 60min

• To evaluate the velocity displacement of blood about 2 planes (intracranial plane, C2-C3)

  Time PC-MRI will be around 60min

Study Arms (1)

Phase Contrast MRI

EXPERIMENTAL

Other: MRI Contrast

Interventions

MRI Contrast OTHER

Pass a Phase Contrast MRI. No injection required.

Phase Contrast MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

C.H.U. Poitiers

Poitiers, 86000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: September 24, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: January 5, 2026

Record last verified: 2026-01

Locations

FR (1)