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

March 19, 2013
March 19, 2013
March 2006
July 2008   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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)
Same as current
Not Provided
Not Provided
 
Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

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.

Not Provided
Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Normal Pressure Hydrocephalus
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
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.
Intervention: Other: clinical and imaging examinations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2009
July 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01815775
PI05-PR-LEGARS, 2006/0023
No
Centre Hospitalier Universitaire, Amiens
Centre Hospitalier Universitaire, Amiens
Not Provided
Not Provided
Centre Hospitalier Universitaire, Amiens
March 2013

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