Flow MRI in Normal Pressure Hydrocephalus (HydroFlux)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01909960
First received: May 24, 2013
Last updated: April 22, 2014
Last verified: April 2014

May 24, 2013
April 22, 2014
June 2012
June 2014   (final data collection date for primary outcome measure)
cerebrospinal fluid (CSF) stroke volume evolution other 6 months [ Time Frame: Day 1 (baseline), Day 180 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01909960 on ClinicalTrials.gov Archive Site
  • Blood flow analysis : evolution other 6 months [ Time Frame: Day 1 (baseline), Day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, Day 180 ] [ Designated as safety issue: No ]
    Record symptoms on walking, living conditions and urinary disorders
  • Neuropsychological test evolution over 6 months [ Time Frame: Day1, Day 180 ] [ Designated as safety issue: No ]
    Consists in mini mental status evaluation (MMSE) for cognitive evaluation
  • Blood flow analysis : evolution other one year [ Time Frame: Day 1 (baseline) and Day 365 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 and Day 365 ] [ Designated as safety issue: No ]
    Record symptoms on walking, living conditions and urinary disorders
  • Neuropsychological test evolution over one year [ Time Frame: Day1, Day 365 ] [ Designated as safety issue: No ]
    Consists in mini mental status evaluation (MMSE) for cognitive evaluation
  • cerebrospinal fluid (CSF) stroke volume evolution other one year [ Time Frame: Day1 (baseline), Day 365 ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Flow MRI in Normal Pressure Hydrocephalus
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Normal Pressure Hydrocephalus
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: Surgery
    Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)
    Intervention: Other: Flow imaging
  • Experimental: Clinical follow-up
    Patients who will undergo flow imaging but not surgery (75% of the studied population)
    Intervention: Other: Flow imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
184
June 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Olivier Balédent, PhD +33 3 22 66 86 73 olivier.baledent@chu-amiens.fr
France
 
NCT01909960
PHRC-IR-11-DR-BALEDENT, 2011-A01633-38
No
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
Not Provided
Principal Investigator: Olivier Balédent, PhD CHU Amiens
Centre Hospitalier Universitaire, Amiens
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP