Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Normal Pressure Hydrocephalus Clinical Trial

Official title:

Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815775
• Other study ID #: PI05-PR-LEGARS
• Secondary ID: 2006/0023
• Status: Completed
• Phase: Phase 0
• First received: March 19, 2013
• Last updated: March 19, 2013
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: March 2013
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: DGS - Delegation générale de la Santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF stroke volume	Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level	Day 1	No
Secondary	Hakim's triad evaluation	Assessment of the signs of normal pressure hydrocephalus	Day 1	No
Secondary	Hakim's triad evaluation	Assessment of the signs of normal pressure hydrocephalus (follow-up)	Day 90	No
Secondary	Hakim's triad evaluation	Assessment of the signs of normal pressure hydrocephalus (follow-up)	Day 365	No
Secondary	Neuropsychological test	classical neuropsychological assessment (including mini mental status evaluation)	Day 1	No
Secondary	Neuropsychological test	classical neuropsychological assessment (including mini mental status evaluation) (follow up)	Day 90	No
Secondary	Neuropsychological test	classical neuropsychological assessment (including mini mental status evaluation) (follow up)	Day 365	No
Secondary	CSF stroke volume	Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)	Day 60	No
Secondary	CSF stroke volume	Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)	Day 365	No