Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Normal Pressure Hydrocephalus	Other: clinical and imaging examinations	Early Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
Study Start Date :	March 2006
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	July 2009

Arms and Interventions

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Arm

Intervention/treatment

Experimental: 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.

Other: 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; Other Names: flow MRI; cine phase-constrast magnetic resonance imaging; CSF pulsatility; hydrodynamic

Outcome Measures

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Primary Outcome Measures :

1. CSF stroke volume [ Time Frame: Day 1 ]
   Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level

Secondary Outcome Measures :

1. Hakim's triad evaluation [ Time Frame: Day 1 ]
   Assessment of the signs of normal pressure hydrocephalus
2. Hakim's triad evaluation [ Time Frame: Day 90 ]
   Assessment of the signs of normal pressure hydrocephalus (follow-up)
3. Hakim's triad evaluation [ Time Frame: Day 365 ]
   Assessment of the signs of normal pressure hydrocephalus (follow-up)
4. Neuropsychological test [ Time Frame: Day 1 ]
   classical neuropsychological assessment (including mini mental status evaluation)
5. Neuropsychological test [ Time Frame: Day 90 ]
   classical neuropsychological assessment (including mini mental status evaluation) (follow up)
6. Neuropsychological test [ Time Frame: Day 365 ]
   classical neuropsychological assessment (including mini mental status evaluation) (follow up)
7. CSF stroke volume [ Time Frame: Day 60 ]
   Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
8. CSF stroke volume [ Time Frame: Day 365 ]
   Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
CHU Amiens
Amiens, Picardie, France, 80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT01815775 History of Changes
Other Study ID Numbers:	PI05-PR-LEGARS; 2006/0023 ( Registry Identifier: DGS )
First Posted:	March 21, 2013
Last Update Posted:	March 21, 2013
Last Verified:	March 2013

Keywords provided by Centre Hospitalier Universitaire, Amiens:

Normal pressure hydrocephalus; flow MRI; dementia; cerebrospinal fluid; shunt

Additional relevant MeSH terms:

Hydrocephalus; Hydrocephalus, Normal Pressure; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases