Trial record 14 of 104 for:    Hydrocephalus

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
  Purpose

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


Condition Intervention
Normal Pressure Hydrocephalus
Other: Flow imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 184
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01909960     History of Changes
Other Study ID Numbers: PHRC-IR-11-DR-BALEDENT, 2011-A01633-38
Study First Received: May 24, 2013
Last Updated: April 22, 2014
Health Authority: France: ANSM Agence nationale de sécurité du médicament (Saint Denis)

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
Intracranial Hypertension

ClinicalTrials.gov processed this record on July 20, 2014