Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide
This study is for people who have Idiopathic Intracranial Hypertension (IIH), a condition where there's too much pressure around the brain. This can lead to problems like headaches, vision changes, and ringing in the ears. If you've been taking a medicine called acetazolamide for over a year but are still struggling with symptoms or side effects, this study might be for you. We're investigating if placing a small tube, called a stent, into a specific vein in the brain can lower this pressure and improve your symptoms. Participants will either continue with their usual care (medication and advice on healthy weight) or receive the stent in addition to their usual care. We'll check on your progress for 12 months.
At a glance
What is this study about?
You might have heard of Idiopathic Intracranial Hypertension (IIH) before. It's a condition where the pressure inside your head becomes too high without an obvious cause. This extra pressure can lead to uncomfortable symptoms like ongoing headaches, problems with your vision, and a buzzing or ringing sound in your ears (tinnitus). Often, people with IIH are found to have a narrowed vein in their brain called the transverse sinus, which is thought to contribute to this increased pressure. Standard treatments usually involve medication and lifestyle changes, like weight loss.
This study, called DIVE-IIN-LATE, is looking into whether a medical procedure called stenting could offer a better solution for some people with IIH. Stenting involves carefully placing a small mesh tube, or 'stent', into the narrowed vein in your brain to help keep it open. The idea is that opening up this narrowed vein might reduce the pressure inside your head and, in turn, relieve your symptoms. While stenting is sometimes used, this study aims to gather strong evidence to see if it's truly more effective than current treatments alone.
The main goal is to find out if transverse sinus stenting could significantly improve how IIH is managed for patients who haven't fully benefited from long-term medication. If this study shows positive results, it could mean a big step forward in offering more effective treatment options for people living with IIH.
Key takeaways
- This study investigates if a stent can help manage brain pressure in IIH.
- It's for people with IIH who haven't fully responded to a year of acetazolamide.
- Participants will either get standard care or a stent plus standard care.
- The study involves follow-up appointments over 12 months.
- It aims to find new and better ways to treat IIH symptoms.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a clear diagnosis of Idiopathic Intracranial Hypertension (IIH). You should have been taking acetazolamide medication for your IIH for over a year, but still be experiencing issues such as bothersome side effects or your symptoms aren't well controlled. We'll also check if you have a specific type of narrowing in a brain vein (called the transverse sinus) that shows up on an MRI scan, as this is what the stent would target.
There are also some reasons why you might not be able to join. For example, if you've recently taken certain other medications (like topiramate) or substances that can affect brain pressure. We also can't include you if you've previously had a blood clot or a tumour in your brain. People with severe vision loss, certain eye conditions, or who are pregnant would also not be able to take part. It's important to be generally healthy enough to attend all study appointments and undergo the procedures involved.
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?
- Do you have a clear diagnosis of IIH?
- Have you been taking acetazolamide for more than a year but still have symptoms or side effects?
- Do you have a specific narrowing in a brain vein shown on an MRI?
- Are you able to attend all planned follow-up appointments for a year?
What does participation involve?
If you decide to join this study, you'll first be assessed to make sure you meet all the requirements. You'll then be randomly placed into one of two groups: one group will continue with standard medical care, which includes your recommended medication and advice on weight loss; the other group will receive the stent procedure in addition to this standard medical care. The stent will be placed in a specific vein in your brain.
Regardless of which group you're in, you'll have specific follow-up appointments scheduled at 1 month, 3 months, and 12 months after starting the study. These visits will involve various checks and tests to see how you're responding and to monitor any changes in your symptoms and brain pressure. You'll need to be available to attend all these scheduled visits over the course of the year-long study.
Potential risks and benefits
Locations (3)
- CHU de Montpellier Hôpital Gui de ChauliacVerified postcodeMontpellier, France· Recruiting
- CHU de ReimsVerified postcodeReims, France· Not yet recruiting
- CHU de ToulouseVerified postcodeToulouse, France· Not yet recruiting
Common questions
What is IIH?
IIH stands for Idiopathic Intracranial Hypertension, a condition where there's too much fluid pressure around your brain, causing symptoms like headaches and vision issues.
What is a stent?
A stent is a small, mesh tube that doctors place inside a narrowed blood vessel to help keep it open and improve blood flow.
Will I definitely get the stent if I join?
No, participants are randomly assigned to either receive the stent plus standard care or just standard care. It's like flipping a coin to decide.
How long will the study last for me?
You will have follow-up visits for 12 months after you start the study treatments.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point without it affecting your medical care.
How to find out more
Vincent COSTALAT, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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