Clinical trial NCT04115553: Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
Official title: Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Hypertension
Keywords: Intracranial Hypertension
venous drainage
MRI
blood flow
cerebrospinal fluid flow
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Ratio between jugular vein flow and total arterial brain flow.
timeFrame: day 0 = day of inclusion
Secondary outcomes:
measure: CSF (cerebrospinal fluid) Stroke volumes
timeFrame: day 0 = day of inclusion
Other outcomes:
Locations:
city: Salouël
country: France
facility: CHU Amiens
Study officials:
References: