Flow MRI in Normal Pressure Hydrocephalus

NCT ID: NCT01909960

Last Updated: 2018-08-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-03

Study Completion Date

2018-09-30

Brief Summary

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Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.

Detailed Description

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Conditions

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Normal Pressure Hydrocephalus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Surgery

Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)

Group Type EXPERIMENTAL

Flow imaging

Intervention Type OTHER

Quantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.

Clinical examination consists in Larson's score and MMSE

Clinical follow-up

Patients who will undergo flow imaging but not surgery (75% of the studied population)

Group Type EXPERIMENTAL

Flow imaging

Intervention Type OTHER

Quantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.

Clinical examination consists in Larson's score and MMSE

Interventions

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Flow imaging

Quantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.

Clinical examination consists in Larson's score and MMSE

Intervention Type OTHER

Other Intervention Names

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Flow MRI Cine phase-constrast magnetic resonance imaging CSF pulsatility Hydrodynamic Cerebral blood flow

Eligibility Criteria

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Inclusion Criteria

* Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
* Walking disorder
* Cognitive disorder
* Participants gave their written informed consent

Exclusion Criteria

* Contra-indication to MRI
* Obstructive tumoral hydrocephalus
* Curatorship or tutorship
* Pregnancy or lactation
* No social assurance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Balédent, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Lille

Lille, Hauts-de-France, France

Site Status

CHU Amiens

Amiens, Picardie, France

Site Status

Countries

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France

Other Identifiers

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2011-A01633-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHRCIR11-DR-BALEDENT

Identifier Type: -

Identifier Source: org_study_id

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