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Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01815775
First received: March 19, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.

In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.


Condition Intervention Phase
Normal Pressure Hydrocephalus
 Other: clinical and imaging examinations
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • CSF stroke volume [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level


Secondary Outcome Measures:
  • Hakim's triad evaluation [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Assessment of the signs of normal pressure hydrocephalus

  • Hakim's triad evaluation [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Assessment of the signs of normal pressure hydrocephalus (follow-up)

  • Hakim's triad evaluation [ Time Frame: Day 365 ] [ Designated as safety issue: No ]
    Assessment of the signs of normal pressure hydrocephalus (follow-up)

  • Neuropsychological test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    classical neuropsychological assessment (including mini mental status evaluation)

  • Neuropsychological test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    classical neuropsychological assessment (including mini mental status evaluation) (follow up)

  • Neuropsychological test [ Time Frame: Day 365 ] [ Designated as safety issue: No ]
    classical neuropsychological assessment (including mini mental status evaluation) (follow up)

  • CSF stroke volume [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)

  • CSF stroke volume [ Time Frame: Day 365 ] [ Designated as safety issue: No ]
    Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
Enrollment: 30
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal pressure hydrocephalus
Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery.
 Other: clinical and imaging examinations

Quantitative CSF 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 flow was measured with a velocity-encoding value of 10-20 cm/s. 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 neuropsychological assessment (including mini mental state examination test and Bradley's scale) as well as Hakim's triad evaluation

Other Names:
  • flow MRI
  • cine phase-constrast magnetic resonance imaging
  • CSF pulsatility
  • hydrodynamic

  Eligibility
Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age: over 20 years
  • diagnostic of normal pressure hydrocephalus
  • ventricular dilation visible on radiological examination
  • patients gave their written informed consent

Exclusion Criteria:

  • age: less than 20 years
  • MRI contra-indication
  • pregnancy
  • lumbar puncture within 48 hours before MRI
  • cardiac arrhythmia
  • cerebral/lacunar stroke
  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: NCT01815775

Locations
France
CHU Amiens
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
  More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01815775     History of Changes
Other Study ID Numbers: PI05-PR-LEGARS  2006/0023 
Study First Received: March 19, 2013
Last Updated: March 19, 2013
Health Authority: France: DGS - Delegation générale de la Santé

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

ClinicalTrials.gov processed this record on September 30, 2016