Flow MRI in Normal Pressure Hydrocephalus (HydroFlux)

Centre Hospitalier Universitaire, Amiens

Status: Unknown

Conditions: Normal Pressure Hydrocephalus

Treatments: Other: Flow imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01909960

PHRCIR11-DR-BALEDENT

2011-A01633-38 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Surgery

Experimental group

Description:

Patients who will undergo flow imaging and neurosurgery (shunting). (25% of the studied population)

Treatment:

Other: Flow imaging

Clinical follow-up

Experimental group

Description:

Patients who will undergo flow imaging but not surgery (75% of the studied population)

Treatment:

Other: Flow imaging