NCT01815775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2006

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

March 19, 2013

Last Update Submit

September 16, 2025

Conditions

Normal Pressure Hydrocephalus

Keywords

Normal pressure hydrocephalusflow MRIdementiacerebrospinal fluidshunt

Outcome Measures

Primary Outcomes (1)

  • CSF stroke volume

    Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level

    Day 1

Secondary Outcomes (8)

  • Hakim's triad evaluation

    Day 1

  • Hakim's triad evaluation

    Day 90

  • Hakim's triad evaluation

    Day 365

  • Neuropsychological test

    Day 1

  • Neuropsychological test

    Day 90

  • +3 more secondary outcomes

Study Arms (1)

Normal pressure hydrocephalus

EXPERIMENTAL

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

Interventions

clinical and imaging examinationsOTHER

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

Also known as: flow MRI, cine phase-constrast magnetic resonance imaging, CSF pulsatility, hydrodynamic
Normal pressure hydrocephalus

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, Picardie, 80054, France

Location

Related Publications (1)

  • Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.

    PMID: 20097391RESULT

MeSH Terms

Conditions

Hydrocephalus, Normal PressureDementia

Interventions

Hydrodynamics

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 21, 2013

Study Start

March 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2009

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations

FR(1)