An Early Phase 1 interventional study of clinical and imaging examinations in Normal Pressure Hydrocephalus, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Centre Hospitalier Universitaire, Amiens · Early Phase 1, Interventional, and Other
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.
71 studies on the registry are indexed under Hydrocephalus, Normal Pressure; 17 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 37 interventional studies indexed under Hydrocephalus, Normal Pressure.
Browse Hydrocephalus, Normal Pressure studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
CSF stroke volume
Measurement of CSF stroke volume via flow MRI at the Sylvius' aqueduct level
Time frame: Day 1
Hakim's triad evaluation
Assessment of the signs of normal pressure hydrocephalus
Time frame: Day 1
Hakim's triad evaluation
Assessment of the signs of normal pressure hydrocephalus (follow-up)
Time frame: Day 90
Hakim's triad evaluation
Assessment of the signs of normal pressure hydrocephalus (follow-up)
Time frame: Day 365
Neuropsychological test
classical neuropsychological assessment (including mini mental status evaluation)
Time frame: Day 1
Neuropsychological test
classical neuropsychological assessment (including mini mental status evaluation) (follow up)
Time frame: Day 90
Neuropsychological test
classical neuropsychological assessment (including mini mental status evaluation) (follow up)
Time frame: Day 365
CSF stroke volume
Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
Time frame: Day 60
CSF stroke volume
Measurement of CSF stroke volume by flow MRI at the Sylvius' aqueduct level (follow-up)
Time frame: Day 365
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hydrocephalus, Normal Pressure→
Centre Hospitalier Universitaire, Amiens