Flow MRI in Normal Pressure Hydrocephalus (HydroFlux)

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

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

Study Overview

• Status: Unknown
• Conditions: Normal Pressure Hydrocephalus
• Intervention / Treatment: Other: Flow imaging

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nord Pas De Calais
    • Lille, Nord Pas De Calais, France, 59000
      • Chu Lille
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebrospinal fluid (CSF) stroke volume evolution other 6 months	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	Day 1 (baseline), Day 180

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood flow analysis : evolution other 6 months	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.	Day 1 (baseline), Day 180
Larson's score evolution over 6 months	Record symptoms on walking, living conditions and urinary disorders	Day 1, Day 180
Neuropsychological test evolution over 6 months	Consists in mini mental status evaluation (MMSE) for cognitive evaluation	Day1, Day 180
Blood flow analysis : evolution other one year	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.	Day 1 (baseline) and Day 365
Larson's score evolution over one year	Record symptoms on walking, living conditions and urinary disorders	Day 1 and Day 365
Neuropsychological test evolution over one year	Consists in mini mental status evaluation (MMSE) for cognitive evaluation	Day1, Day 365
cerebrospinal fluid (CSF) stroke volume evolution other one year	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	Day1 (baseline), Day 365

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Olivier Balédent, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2012
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: May 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Dementia; Cerebrospinal fluid; Shunt; Normal pressure hydrocephalus; Flow MRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Hydrocephalus, Normal Pressure
• Other Study ID Numbers: PHRCIR11-DR-BALEDENT; 2011-A01633-38 (Registry Identifier: RCB)