Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Early Phase 1

Completed

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Other: clinical and imaging examinations

• Registration Number: NCT01815775
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-07
• Study Completion: 2009-07
• Status Verified: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-19
• Last Update Submitted: 2013-03-19
• Study First Posted: 2013-03-21
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal pressure hydrocephalus	clinical and imaging examinations	Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery.

Primary Outcome Measures

Name	Time	Method
CSF stroke volume	Day 1	Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level

Secondary Outcome Measures

Name	Time	Method
Hakim's triad evaluation	Day 365	Assessment of the signs of normal pressure hydrocephalus (follow-up)
Neuropsychological test	Day 365	classical neuropsychological assessment (including mini mental status evaluation) (follow up)
CSF stroke volume	Day 365	Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, Picardie, France