Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

NCT04115553 | Active Not Recruiting

• 1 other identifier: PI2019_843_0056
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intracranial hypertension (IIH) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. The most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. There are many options for the treatment of IIH, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). Currently, idiopathic IIH has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. The assumption of venous insufficiency has not been demonstrated so far. Therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. Assessment will be performed using Magnetic Resonance Imaging which is part of the patient care.

Conditions

Intracranial Hypertension

Keywords

Intracranial Hypertension; venous drainage; MRI; blood flow; cerebrospinal fluid flow

Outcome Measures

Primary Outcomes (1)

• Ratio between jugular vein flow and total arterial brain flow.

  Venous jugular flow is the sum right and left internal jugular vein flows. Total arterial flow is the sum of right and left internal carotid and vertebral arteries flows.

  day 0 = day of inclusion

Secondary Outcomes (1)

• CSF (cerebrospinal fluid) Stroke volumes

  day 0 = day of inclusion

Study Arms (2)

idiopathic intracranial hypertension

EXPERIMENTAL

patients with idiopathic intracranial hypertension

Diagnostic Test: MRI examination; Diagnostic Test: ECG

healthy subjects

SHAM COMPARATOR

Healthy subjects

Diagnostic Test: MRI examination; Diagnostic Test: ECG

Interventions

MRI examination DIAGNOSTIC_TEST

Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. Standard MRI examination using a 32-channel head coil consists of angiographic, morphological and phase-contrast 2D flow sequences. The flow planes are set perpendicularly to the structure axis (blood or CSF regions). The velocity measured in the pixels inside the region of interest allow the calculation of a mean flow rate as well as the volume displaced during a cardiac cycle.

Also known as: Magnetic resonance imaging (MRI)

healthy subjects; idiopathic intracranial hypertension

ECG DIAGNOSTIC_TEST

A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.

Also known as: Electrocardiogram

healthy subjects; idiopathic intracranial hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age : \>18 years old
• adult patients referred to the imaging department for intracranial hypertension assessment
• adult control subjects without history of cerebral or vascular pathology

You may not qualify if:

• history of cerebral or vascular pathology for the control subjects
• pregnant woman
• claustrophobia
• major obesity
• any contraindication to MRI exam

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Salouël, 80480, France

Location

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Magnetic Resonance Imaging; Electrocardiography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: February 19, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)