- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06743347
Dynamic Measurement of Cerebrospinal Fluid in Healthy Subjects: Pilot Study (DYNA-LCS P)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Poitiers, France, 86000
- C.H.U. Poitiers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase Contrast MRI
|
Pass a Phase Contrast MRI.
No injection required.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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)
Time Frame: Time PC-MRI will be around 60min
|
Displacement velocities of CSF will be obtain by Phase Contrats MRI.
|
Time PC-MRI will be around 60min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Using morphological MRI to model a digital twin
Time Frame: Time PC-MRI will be around 60min
|
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)
Time Frame: Time PC-MRI will be around 60min
|
Displacement velocities of blood will be obtain by Phase Contrats MRI.
|
Time PC-MRI will be around 60min
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024-A02411-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebrospinal Fluid
-
Assiut UniversityRecruiting
-
Universitaire Ziekenhuizen KU LeuvenRecruitingCerebrospinal FluidBelgium
-
Wake Forest University Health SciencesCompletedCerebrospinal Fluid ShuntsUnited States
-
The Cleveland ClinicCompletedCerebrospinal Fluid Drainage Catheter
-
First People's Hospital of ChenzhouNot yet recruiting
-
Yi Feng, MDUnknownAged | Flurbiprofen Axetil | Anesthesia, Spinal | Cerebrospinal FluidChina
-
Top Health S.A.P.I DE C.V.CLINICAL RESEARCH PS MEXICOTerminatedCerebrospinal Fluid LeakageMexico
-
Kuros Biosurgery AGCompletedCerebrospinal Fluid LeakageGermany, Hungary
-
TakedaCompletedCerebrospinal Fluid LeaksAustria, Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Russian Federation, Spain, Sweden
-
University of ZurichCompletedCerebrospinal Fluid LeakageSwitzerland
Clinical Trials on MRI Contrast
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingPatients with Atrial Fibrillation and Healthy Volunters
-
Seoul National University Bundang HospitalBayerCompletedTraumaKorea, Republic of
-
Imperial College LondonNational Institute for Health Research, United Kingdom; Imperial College Healthcare...WithdrawnMyocardial Fibrosis | Heart Failure | End Stage Renal Failure on Dialysis | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe)United Kingdom
-
University of WashingtonNational Cancer Institute (NCI)Active, not recruiting
-
The Cleveland ClinicUniversity of Pennsylvania; Cedars-Sinai Medical CenterRecruiting
-
University of MinnesotaTerminated
-
Bristol-Myers SquibbPfizerCompletedThrombosisArgentina, United States, Germany, Mexico, Canada, Netherlands, Brazil, Austria, United Kingdom
-
University of CincinnatiActive, not recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institute of Dental and Craniofacial...Recruiting
-
Assiut UniversityRecruiting