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NCT04145414 Clinical Trial

Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

Mri Clinical Trial

— MLCSFIV  

Official title:
Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04145414
Other study ID # P/2019/425
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 13, 2019
Est. completion date January 14, 2020

Study information
Verified date November 2021
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

Description:

It is a monocentric interventional prospective study. Each subject will have to pass two MRI. Phase contrast MRI (PC-MRI) will be calibrated for each subject by assessing the optimal encoding velocity. Three sequences including the aqueduct and the two interventricular foramina (IVF) will be done. The signal will be analysed by syngo.via software after defining by two different investigators the region of interest (ROI) which correspond to the IVF or the aqueductal lumen. Descriptive statistics will test the intra-individual and inter-observer consistency based on 4 flow parameters.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date January 14, 2020
Est. primary completion date January 14, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Mini-Mental State Examination score > 28/30 Exclusion Criteria: - MRI contraindication - Medical or surgical history related to following pathologies: nervous system disease, cardiac arrhythmia, cardiac or respiratory insufficiency. - Long-term medical treatment - Ongoing pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MRI
Reproductibility test assessed with MRI for cerebrospinal fluid movements

Locations
Country Name City State
France CHU de Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary PC-MRI procedure reproductibility Test-retest reproducibility of double measures (2nd measure at +48 hours minimum +6 weeks maximum) of 4 cerebrospinal liquid (CSL) flow parameters during PC-MRI.
CSL flow through interventricular foramina will be measured within healthy volunteers, and 4 intraclass correlation coefficients (ICC) will be calculated.
The test-retest coefficient will be considered satisfactory if > or = to 0.75 .		 week 6
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