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NCT Number: NCT04115553

Assessment of Venous Drainage in Idiopathic Intracranial Hypertension

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Salouël, 80480, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Magnetic resonance imaging (MRI)

ECG

Diagnostic Test

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

Other names: Electrocardiogram

Primary outcomes

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

    Time frame: 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 outcomes

  1. CSF (cerebrospinal fluid) Stroke volumes

    Time frame: day 0 = day of inclusion

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: HYPERPIC

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 4, 2019
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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