Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
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ClinicalTrials.gov Identifier: NCT01815775 |
Recruitment Status
:
Completed
First Posted
: March 21, 2013
Last Update Posted
: March 21, 2013
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Normal Pressure Hydrocephalus | Other: clinical and imaging examinations | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Normal pressure hydrocephalus
Hydrocephalus patients planned for shunting surgery. They will undergo clinical and imaging examinations at day 1, 3 months and 1 year after their surgery.
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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 Other Names:
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- CSF stroke volume [ Time Frame: Day 1 ]Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level
- Hakim's triad evaluation [ Time Frame: Day 1 ]Assessment of the signs of normal pressure hydrocephalus
- Hakim's triad evaluation [ Time Frame: Day 90 ]Assessment of the signs of normal pressure hydrocephalus (follow-up)
- Hakim's triad evaluation [ Time Frame: Day 365 ]Assessment of the signs of normal pressure hydrocephalus (follow-up)
- Neuropsychological test [ Time Frame: Day 1 ]classical neuropsychological assessment (including mini mental status evaluation)
- Neuropsychological test [ Time Frame: Day 90 ]classical neuropsychological assessment (including mini mental status evaluation) (follow up)
- Neuropsychological test [ Time Frame: Day 365 ]classical neuropsychological assessment (including mini mental status evaluation) (follow up)
- CSF stroke volume [ Time Frame: Day 60 ]Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
- CSF stroke volume [ Time Frame: Day 365 ]Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815775
France | |
CHU Amiens | |
Amiens, Picardie, France, 80054 |
Responsible Party: | Centre Hospitalier Universitaire, Amiens |
ClinicalTrials.gov Identifier: | NCT01815775 History of Changes |
Other Study ID Numbers: |
PI05-PR-LEGARS 2006/0023 ( Registry Identifier: DGS ) |
First Posted: | March 21, 2013 Key Record Dates |
Last Update Posted: | March 21, 2013 |
Last Verified: | March 2013 |
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Normal pressure hydrocephalus flow MRI dementia cerebrospinal fluid shunt |
Additional relevant MeSH terms:
Hydrocephalus Hydrocephalus, Normal Pressure Brain Diseases Central Nervous System Diseases Nervous System Diseases |