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

NCT ID: NCT04145414

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-13

Study Completion Date

2020-01-14

Brief Summary

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

Detailed Description

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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.

Conditions

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CSF Circulation Disorder Foramen; Monro, Obstruction Mri

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cerebral magnetic resonance imaging x2

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

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

Reproductibility test assessed with MRI for cerebrospinal fluid movements

Interventions

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MRI

Reproductibility test assessed with MRI for cerebrospinal fluid movements

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent TATU, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

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CHU de Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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P/2019/425

Identifier Type: -

Identifier Source: org_study_id

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