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Flow MRI in Normal Pressure Hydrocephalus (HydroFlux)

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ClinicalTrials.gov Identifier: NCT01909960
Recruitment Status : Recruiting
First Posted : July 29, 2013
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Normal Pressure Hydrocephalus Other: Flow imaging

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
Study Start Date : June 2012
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Surgery
Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)
Other: Flow imaging

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
Experimental: Clinical follow-up
Patients who will undergo flow imaging but not surgery (75% of the studied population)
Other: Flow imaging

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909960


Contacts
Contact: Olivier Balédent, PhD +33 3 22 66 86 73 olivier.baledent@chu-amiens.fr

Locations
France
CHU Caen Not yet recruiting
Caen, Basse Normandie, France, 14000
Contact: Patrick Courtheoux, MD,PhD    +33 2 31 06 46 88    courtheoux-p@chu-caen.fr   
Principal Investigator: Patrick Courtheoux, MD,PhD         
Sub-Investigator: Evelyne Emery, MD,PhD         
CHU Rouen Not yet recruiting
Rouen, Haute Normandie, France, 76000
Contact: Emmanuel Gerardin, MD    +33 2 32 88 86 31    emmanuel.gerardin@chu-rouen.fr   
Principal Investigator: Emmanuel Gerardin, MD         
Sub-Investigator: François Proust, MD,PhD         
CHU Lille Recruiting
Lille, Nord Pas de Calais, France, 59000
Contact: Marc Baroncini, MD    +33 3 20 44 65 55    marc.baroncini@inserm.fr   
Sub-Investigator: Marc Baroncini, MD         
Sub-Investigator: Jean-Paul Lejeune, MD,PhD         
Principal Investigator: Jean-Pierre Pruvo, MD,PhD         
CHU Amiens Recruiting
Amiens, Picardie, France, 80054
Contact: Olivier Balédent, PhD    +33 3 22 66 86 73    olivier.baledent@chu-amiens.fr   
Sub-Investigator: Daniel Le Gars, MD         
Principal Investigator: Olivier Balédent, PhD         
Sub-Investigator: Anthony Fichten, MD         
Sub-Investigator: Catherine Gondry-Jouet, MD         
Sub-Investigator: Hervé Deramond, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Olivier Balédent, PhD CHU Amiens
More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01909960     History of Changes
Other Study ID Numbers: PHRCIR11-DR-BALEDENT
2011-A01633-38 ( Registry Identifier: RCB )
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016

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