Dynamic Measurement of Cerebrospinal Fluid in Healthy Sub... | NCT06743347

Studies
Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study

NCT06743347

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Jan 5, 2026Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Cerebrospinal Fluid
Healthy Subjects or Volunteers

Interventions

MRI Contrast

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2025Actual

Primary Completion Date

Dec 17, 2025Actual

Completion Date

Dec 17, 2025Actual

First Submitted Date

Dec 16, 2024

First Submission Date that Met QC Criteria

Dec 16, 2024

First Posted Date

Dec 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2026

Last Update Posted Date

Jan 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Label	Type	Description	Intervention Names
Phase Contrast MRI	Experimental		Other: MRI Contrast

Name	Type	Description	Arm Group Labels	Other Names
MRI Contrast	Other	Pass a Phase Contrast MRI. No injection required.	Phase Contrast MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Using morphological MRI to model a digital twin	Comparison of velocity fields for each measurement section plane	Time PC-MRI will be around 60min
To evaluate the velocity displacement of blood about 2 planes (intracranial plane, C2-C3)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided