Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

Not Applicable

Recruiting

• Conditions: Intracranial Hypertension
• Interventions: Diagnostic Test: MRI examination; Diagnostic Test: ECG

• Registration Number: NCT04115553
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-04
• Study Start: 2020-02-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy subjects	ECG	Healthy subjects
idiopathic intracranial hypertension	MRI examination	patients with idiopathic intracranial hypertension
idiopathic intracranial hypertension	ECG	patients with idiopathic intracranial hypertension
healthy subjects	MRI examination	Healthy subjects

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
CSF (cerebrospinal fluid) Stroke volumes	day 0 = day of inclusion	CSF oscillatory volumes measured at the Sylvius' aqueduct and sub-arachnoidian space levels

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Salouël, France