RecruitingNAINTERVENTIONAL

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

This research is looking into better ways to help people with Idiopathic Intracranial Hypertension (IIH). This condition causes high pressure inside the skull, which can sometimes affect eyesight. Usually, medication is tried first, but if that doesn't work well or causes too many side effects, other options are needed. This study specifically compares two types of procedures: a neurosurgical shunt, which helps drain fluid from the brain, and a venous sinus stent, which is a small tube placed in a blood vessel to improve blood flow. Both methods aim to reduce the pressure and protect vision. We want to find out which one works best and is safest for patients with moderate to severe vision problems due to IIH.

At a glance

Status

Recruiting

Phase

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrolment target

276

Start

02 Mar 2022

Estimated completion

07 Dec 2026

Pseudotumor Cerebri Cerebrospinal Fluid Transverse Sinuses

What is this study about?

Idiopathic Intracranial Hypertension (often called IIH) is a condition where the pressure inside your head becomes too high. The word 'idiopathic' means we don't fully understand why it happens. It's more common in young women. This high pressure can squeeze the nerves that go to your eyes, leading to something called papilledema (swelling of your optic nerve). If not treated, this swelling can cause vision problems, from blurred vision to even blindness over time.

Doctors usually try to treat IIH first with weight loss and medication like acetazolamide. This medicine helps reduce the amount of fluid in your brain. However, for some people, these treatments might not work well enough, or they might cause unpleasant side effects. When that happens, doctors need to consider other options to protect the patient's eyesight and reduce the pressure.

This study is comparing two main procedures for people whose medication hasn't worked for their IIH. One is a 'shunt' surgery, where a thin tube is put in place to help drain excess fluid from the brain to another part of the body, like the tummy, where it can be safely absorbed. The other is 'venous sinus stenting,' which involves putting a small mesh tube, called a stent, into a narrowed vein in the brain to open it up and improve blood flow. Both of these treatments have been shown to help reduce the pressure and protect vision. This research aims to understand which of these two approaches is more effective and safer for patients with continued vision problems.

Key takeaways

IIH causes high pressure in the head, potentially affecting vision.
This study compares two procedures: brain fluid drainage (shunt) and vein opening (stent).
It's for people with moderate to severe vision issues from IIH, where medicine isn't enough.
The aim is to find out which treatment is safer and more effective.
Both treatments are designed to reduce pressure and protect eyesight.

Who may be eligible?

To be able to take part in this study, you would need to be 18 years old or older and have a confirmed diagnosis of IIH with high pressure readings. Crucially, your eyes would need to show signs of swelling (papilledema), and scans would need to show a narrowing in at least one of the major veins in your brain (transverse sinus).

It's important that you've already tried and not gotten enough relief from standard medical treatments, and your medical team believes you need one of these procedures. You would also need to feel comfortable agreeing to participate in the study.

However, some conditions would mean you couldn't join. This includes if you have a very sudden and severe form of IIH, if you can't take blood-thinning medication (antiplatelet aggregation), or if a doctor has said you shouldn't have either of the procedures being studied. Pregnant or breastfeeding women are also unable to participate in this particular trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with IIH and shown to have high pressure in your head?
Do you have swelling of your optic nerves (papilledema)?
Have scans shown a narrowing in a vein in your brain (transverse sinus)?
Has your current IIH medication not worked well enough for you?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo either a neurosurgical shunt procedure or a venous sinus stenting procedure, depending on what the study assigns you to. The shunt involves surgery to place a tube and a valve. The stenting procedure involves a doctor inserting a small mesh tube into a vein in your brain, and you would need to take blood-thinning medication for about six months afterwards. Throughout the study, you would have regular check-ups and assessments to monitor your vision, brain pressure, and overall health. The specific number of visits and the total length of your participation would be explained in full by the study team.

Potential risks and benefits

Participating in this study might offer the benefit of potentially better management of your IIH and improved or stabilised vision through one of these established procedures. However, as with any medical procedure, there are potential risks, which will be fully explained to you before you agree to take part. These could include general surgical risks, risks specific to a shunt or stent, and side effects from medications. The purpose of this study is to compare the safety and effectiveness of these two treatments. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Fondation A De Rothschild
Verified postcode
Paris, France· Recruiting

Common questions

What is IIH?

IIH stands for Idiopathic Intracranial Hypertension. It's a condition where the pressure inside your head is too high, often without a clear reason.

Why is high pressure in my head a problem?

High pressure can affect your optic nerves, which are important for vision, and can lead to vision changes or even blindness if not treated.

What is a 'shunt' operation?

It's a surgery where a thin tube is put in to drain excess fluid from your brain to another part of your body where it can be absorbed.

What is 'venous sinus stenting'?

This procedure involves placing a small mesh tube (stent) into a narrowed vein in your brain to help improve blood flow and reduce pressure.

Who is this study for?

This study is for adults with IIH whose vision is affected and whose usual medications haven't worked well enough.

How to find out more

Amélie Yavchitz, MD

ayavachitz@for.paris (0)148036454 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.