Flow MRI in Normal Pressure Hydrocephalus

Not Applicable

• Conditions: Normal Pressure Hydrocephalus
• Interventions: Other: Flow imaging

• Registration Number: NCT01909960
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-03
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Flow imaging	Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)
Clinical follow-up	Flow imaging	Patients who will undergo flow imaging but not surgery (75% of the studied population)

Primary Outcome Measures

Name	Time	Method
cerebrospinal fluid (CSF) stroke volume evolution other 6 months	Day 1 (baseline), Day 180	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

Secondary Outcome Measures

Name	Time	Method
Blood flow analysis : evolution other 6 months	Day 1 (baseline), Day 180	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.
Larson's score evolution over 6 months	Day 1, Day 180	Record symptoms on walking, living conditions and urinary disorders
Neuropsychological test evolution over 6 months	Day1, Day 180	Consists in mini mental status evaluation (MMSE) for cognitive evaluation
Blood flow analysis : evolution other one year	Day 1 (baseline) and Day 365	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.
Larson's score evolution over one year	Day 1 and Day 365	Record symptoms on walking, living conditions and urinary disorders
Neuropsychological test evolution over one year	Day1, Day 365	Consists in mini mental status evaluation (MMSE) for cognitive evaluation
cerebrospinal fluid (CSF) stroke volume evolution other one year	Day1 (baseline), Day 365	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

Trial Locations

Locations (2)

CHU Amiens; 🇫🇷 Amiens, Picardie, France

CHU Lille; 🇫🇷 Lille, Nord Pas De Calais, France