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Clinical Trials/NCT04145414
NCT04145414CompletedNot Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country28 target enrollmentStarted: June 13, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
PC-MRI procedure reproductibility

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Cerebral magnetic resonance imaging x2

Experimental

Cerebral MRI performed at enrolment visit and at +6 weeks (maximum)

Intervention: MRI (Device)

Outcomes

Primary Outcomes

PC-MRI procedure reproductibility

Time Frame: 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 .

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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