Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

NCT ID: NCT01815775

Last Updated: 2025-09-19

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

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-07-31

Brief Summary

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The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.

In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.

Detailed Description

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Conditions

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Normal Pressure Hydrocephalus

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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Normal pressure hydrocephalus

Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery.

Group Type EXPERIMENTAL

clinical and imaging examinations

Intervention Type OTHER

Quantitative CSF 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 flow was measured with a velocity-encoding value of 10-20 cm/s. 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 neuropsychological assessment (including mini mental state examination test and Bradley's scale) as well as Hakim's triad evaluation

Interventions

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clinical and imaging examinations

Quantitative CSF 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 flow was measured with a velocity-encoding value of 10-20 cm/s. 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 neuropsychological assessment (including mini mental state examination test and Bradley's scale) as well as Hakim's triad evaluation

Intervention Type OTHER

Other Intervention Names

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flow MRI cine phase-constrast magnetic resonance imaging CSF pulsatility hydrodynamic

Eligibility Criteria

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Inclusion Criteria

* age: over 20 years
* diagnostic of normal pressure hydrocephalus
* ventricular dilation visible on radiological examination
* patients gave their written informed consent

Exclusion Criteria

* age: less than 20 years
* MRI contra-indication
* pregnancy
* lumbar puncture within 48 hours before MRI
* cardiac arrhythmia
* cerebral/lacunar stroke
Minimum Eligible Age

20 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

Locations

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CHU Amiens

Amiens, Picardie, France

Site Status

Countries

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France

References

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Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.

Reference Type RESULT
PMID: 20097391 (View on PubMed)

Other Identifiers

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2006/0023

Identifier Type: REGISTRY

Identifier Source: secondary_id

PI05-PR-LEGARS

Identifier Type: -

Identifier Source: org_study_id

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