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Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01815775
Enrollment
30
Registered
2013-03-21
Start date
2006-03-31
Completion date
2009-07-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Pressure Hydrocephalus

Keywords

Normal pressure hydrocephalus, flow MRI, dementia, cerebrospinal fluid, shunt

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.

Interventions

OTHERclinical 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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CSF stroke volumeDay 1Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level

Secondary

MeasureTime frameDescription
Hakim's triad evaluationDay 1Assessment of the signs of normal pressure hydrocephalus
Neuropsychological testDay 1classical neuropsychological assessment (including mini mental status evaluation)
CSF stroke volumeDay 60Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026