Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Study Overview
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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.

Official Title
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Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Conditions
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Normal Pressure Hydrocephalus

Intervention / Treatment
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* Other: clinical and imaging examinations


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal pressure hydrocephalus<br>Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery. | Other: clinical and imaging examinations<br>* 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<br>* Other names: hydrodynamic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSF stroke volume | Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hakim's triad evaluation | Assessment of the signs of normal pressure hydrocephalus | Day 1 | 
| Hakim's triad evaluation | Assessment of the signs of normal pressure hydrocephalus (follow-up) | Day 90 | 
| Hakim's triad evaluation | Assessment of the signs of normal pressure hydrocephalus (follow-up) | Day 365 | 
| Neuropsychological test | classical neuropsychological assessment (including mini mental status evaluation) | Day 1 | 
| Neuropsychological test | classical neuropsychological assessment (including mini mental status evaluation) (follow up) | Day 90 | 
| Neuropsychological test | classical neuropsychological assessment (including mini mental status evaluation) (follow up) | Day 365 | 
| CSF stroke volume | Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up) | Day 60 | 
| CSF stroke volume | Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up) | Day 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Normal pressure hydrocephalus, flow MRI, dementia, cerebrospinal fluid, shunt