Flow MRI in Normal Pressure Hydrocephalus

Normal Pressure Hydrocephalus Clinical Trial

— HydroFlux  

Official title:

Benefit of Flow Magnetic Resonance Imaging in the Management of Normal Pressure Hydrocephalus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01909960
• Other study ID #: PHRCIR11-DR-BALEDENT
• Secondary ID: 2011-A01633-38
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2012
• Est. completion date: September 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Normal pressure hydrocephalus diagnosis based on quantitative study of cerebro-spinal fluid and blood flow by phase contrast magnetic resonance imaging.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ventricular dilation seen on morphological magnetic resonance imaging (MRI)

• Walking disorder

• Cognitive disorder

• Participants gave their written informed consent

Exclusion Criteria:

• Contra-indication to MRI

• Obstructive tumoral hydrocephalus

• Curatorship or tutorship

• Pregnancy or lactation

• No social assurance

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Other:
• Flow imaging
Quantitative 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 and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. 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 Larson's score and MMSE

Locations

Country	Name	City	State
France	CHU Amiens	Amiens	Picardie
France	CHU Lille	Lille	Nord Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebrospinal fluid (CSF) stroke volume evolution other 6 months	Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution	Day 1 (baseline), Day 180
Secondary	Blood flow analysis : evolution other 6 months	Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.	Day 1 (baseline), Day 180
Secondary	Larson's score evolution over 6 months	Record symptoms on walking, living conditions and urinary disorders	Day 1, Day 180
Secondary	Neuropsychological test evolution over 6 months	Consists in mini mental status evaluation (MMSE) for cognitive evaluation	Day1, Day 180
Secondary	Blood flow analysis : evolution other one year	Assessment of arterial (internal carotids and cerebral arteries) and venous (sagittal sinus, straight sinus) blood flow in terms of mean cerebral blood outflow and stroke volume and determination of blood flow evolution.	Day 1 (baseline) and Day 365
Secondary	Larson's score evolution over one year	Record symptoms on walking, living conditions and urinary disorders	Day 1 and Day 365
Secondary	Neuropsychological test evolution over one year	Consists in mini mental status evaluation (MMSE) for cognitive evaluation	Day1, Day 365
Secondary	cerebrospinal fluid (CSF) stroke volume evolution other one year	Measurement of cerebrospinal fluid (CSF) stroke volume via flow MRI at the Sylvius' aqueduct, pontine cistern and spinal spaces levels and determination of its evolution	Day1 (baseline), Day 365