Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Early Phase 1

Conditions: Normal Pressure Hydrocephalus

Treatments: Other: clinical and imaging examinations

Study type: Interventional

Funder types: Other

Identifiers

NCT01815775

2006/0023 (Registry Identifier)

PI05-PR-LEGARS

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Normal pressure hydrocephalus

Experimental group

Description:

Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery.

Treatment:

Other: clinical and imaging examinations