Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT01815775

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens	Picardie	France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT01815775

Other Study ID Numbers:

PI05-PR-LEGARS
2006/0023

First Posted:

Mar 21, 2013

Last Update Posted:

Mar 21, 2013

Last Verified:

Mar 1, 2013

Keywords provided by Centre Hospitalier Universitaire, Amiens

Normal pressure hydrocephalus

Additional relevant MeSH terms:

Hydrocephalus

Hydrocephalus, Normal Pressure

Study Results

No Results Posted as of Mar 21, 2013