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Completed

NCT Number: NCT01815775

Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

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.

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Key information

Conditions

Normal Pressure Hydrocephalus Brain Diseases Central Nervous System Diseases Dementia Hydrocephalus Hydrocephalus, Normal Pressure Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CHU Amiens

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clinical and imaging examinations

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

Other names: flow MRI, cine phase-constrast magnetic resonance imaging, CSF pulsatility, hydrodynamic

Primary outcomes

  1. CSF stroke volume

    Time frame: Day 1

    Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 21, 2013
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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