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Completed

NCT Number: NCT01909960

Flow MRI in Normal Pressure Hydrocephalus

Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lille, Lille, Hauts-de-France, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ventricular dilation seen on morphological magnetic resonance imaging (MRI)
  • Walking disorder
  • Cognitive disorder
  • Participants gave their written informed consent

Exclusion criteria

  • Contra-indication to MRI
  • Obstructive tumoral hydrocephalus
  • Curatorship or tutorship
  • Pregnancy or lactation
  • No social assurance

Treatment and study plan

Flow imaging

Other

Quantitative 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 and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. 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 Larson's score and MMSE

Other names: Flow MRI, Cine phase-constrast magnetic resonance imaging, CSF pulsatility, Hydrodynamic, Cerebral blood flow

Primary outcomes

  1. cerebrospinal fluid (CSF) stroke volume evolution other 6 months

    Time frame: Day 1 (baseline), Day 180

    Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution

Secondary outcomes

  1. Blood flow analysis : evolution other 6 months

    Time frame: Day 1 (baseline), Day 180

    Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.

  2. Larson's score evolution over 6 months

    Time frame: Day 1, Day 180

    Record symptoms on walking, living conditions and urinary disorders

  3. Neuropsychological test evolution over 6 months

    Time frame: Day1, Day 180

    Consists in mini mental status evaluation (MMSE) for cognitive evaluation

  4. Blood flow analysis : evolution other one year

    Time frame: Day 1 (baseline) and Day 365

    Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.

  5. Larson's score evolution over one year

    Time frame: Day 1 and Day 365

    Record symptoms on walking, living conditions and urinary disorders

  6. Neuropsychological test evolution over one year

    Time frame: Day1, Day 365

    Consists in mini mental status evaluation (MMSE) for cognitive evaluation

  7. cerebrospinal fluid (CSF) stroke volume evolution other one year

    Time frame: Day1 (baseline), Day 365

    Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus

Acronym: HydroFlux

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2013
Registry last updated
Jun 11, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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