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Flow MRI in Normal Pressure Hydrocephalus (HydroFlux)

Primary Purpose

Normal Pressure Hydrocephalus

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Flow imaging
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Normal Pressure Hydrocephalus focused on measuring Normal pressure hydrocephalus, Flow MRI, Dementia, Cerebrospinal fluid, Shunt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Lille
  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Surgery

Clinical follow-up

Arm Description

Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)

Patients who will undergo flow imaging but not surgery (75% of the studied population)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Larson's score evolution over 6 months
Record symptoms on walking, living conditions and urinary disorders
Neuropsychological test evolution over 6 months
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
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.
Larson's score evolution over one year
Record symptoms on walking, living conditions and urinary disorders
Neuropsychological test evolution over one year
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
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

Full Information

First Posted
May 24, 2013
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01909960
Brief Title
Flow MRI in Normal Pressure Hydrocephalus
Acronym
HydroFlux
Official Title
Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2012 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus
Keywords
Normal pressure hydrocephalus, Flow MRI, Dementia, Cerebrospinal fluid, Shunt

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)
Arm Title
Clinical follow-up
Arm Type
Experimental
Arm Description
Patients who will undergo flow imaging but not surgery (75% of the studied population)
Intervention Type
Other
Intervention Name(s)
Flow imaging
Other Intervention Name(s)
Flow MRI, Cine phase-constrast magnetic resonance imaging, CSF pulsatility, Hydrodynamic, Cerebral blood flow
Intervention Description
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
Primary Outcome Measure Information:
Title
cerebrospinal fluid (CSF) stroke volume evolution other 6 months
Description
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
Time Frame
Day 1 (baseline), Day 180
Secondary Outcome Measure Information:
Title
Blood flow analysis : evolution other 6 months
Description
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.
Time Frame
Day 1 (baseline), Day 180
Title
Larson's score evolution over 6 months
Description
Record symptoms on walking, living conditions and urinary disorders
Time Frame
Day 1, Day 180
Title
Neuropsychological test evolution over 6 months
Description
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
Time Frame
Day1, Day 180
Title
Blood flow analysis : evolution other one year
Description
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.
Time Frame
Day 1 (baseline) and Day 365
Title
Larson's score evolution over one year
Description
Record symptoms on walking, living conditions and urinary disorders
Time Frame
Day 1 and Day 365
Title
Neuropsychological test evolution over one year
Description
Consists in mini mental status evaluation (MMSE) for cognitive evaluation
Time Frame
Day1, Day 365
Title
cerebrospinal fluid (CSF) stroke volume evolution other one year
Description
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
Time Frame
Day1 (baseline), Day 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Balédent, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lille
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59000
Country
France
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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Flow MRI in Normal Pressure Hydrocephalus

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