Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

March 19, 2013 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • CSF pulsatility
  • flow MRI
  • cine phase-constrast magnetic resonance imaging
  • hydrodynamic

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Estimate)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI05-PR-LEGARS
  • 2006/0023 (Registry Identifier: DGS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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