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

Not Applicable

Completed

• Conditions: CSF Circulation Disorder; Mri; Foramen; Monro, Obstruction
• Interventions: Device: MRI

• Registration Number: NCT04145414
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-06-13
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Primary Completion: 2020-01-14
• Study Completion: 2020-01-14
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cerebral magnetic resonance imaging x2	MRI	Cerebral MRI performed at enrolment visit and at +6 weeks (maximum)

Primary Outcome Measures

Name	Time	Method
PC-MRI procedure reproductibility	week 6	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 .

Trial Locations

Locations (1)

CHU de Besançon; 🇫🇷 Besançon, France