Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

Only registered users can translate articles

The link is saved to the clipboard

StatusRecruiting

Keywords

Abstract

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.

Description

The investigator working hypothesis is an impairment of the cerebral venous drainage in IIH compared to the circulation observed in healthy volunteers considered as the reference. The research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. MRI support is common for this type of request The reference will be established in a population of healthy volunteers for whom MRI blood flow measurements will be performed. In addition to the primary objective, the investigators assess the impact of IIH on CSF dynamics The study does not present any risk for the subject, any contraindication to MRI examination being respected. The subjects will undergo MRI examination including morphological and flow sequences without contrast injection. The flow sequences, in planes located at the C2-C3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and CSF oscillatory volumes. Image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.

Dates

Last Verified:	01/31/2020
First Submitted:	10/02/2019
Estimated Enrollment Submitted:	10/02/2019
First Posted:	10/03/2019
Last Update Submitted:	02/24/2020
Last Update Posted:	02/25/2020
Actual Study Start Date:	02/18/2020
Estimated Primary Completion Date:	09/30/2022
Estimated Study Completion Date:	09/30/2022

Condition or disease

Intracranial Hypertension

Intervention/treatment

Diagnostic Test: MRI examination

Diagnostic Test: ECG

Phase

Arm Groups

Arm	Intervention/treatment
Experimental: idiopathic intracranial hypertension patients with idiopathic intracranial hypertension
Sham Comparator: healthy subjects Healthy subjects

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: - 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 Exclusion Criteria: - history of cerebral or vascular pathology for the control subjects - pregnant woman - claustrophobia - major obesity - any contraindication to MRI exam

Outcome

Primary Outcome Measures

1. Ratio between jugular vein flow and total arterial brain flow. [day 0 = day of inclusion]

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.

Secondary Outcome Measures

1. CSF (cerebrospinal fluid) Stroke volumes [day 0 = day of inclusion]

CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels

Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

Keywords

headache

edema

tinnitus

pseudotumor cerebri

venous insufficiency