NAIF 2.0 - COGNIFY
The COGNIFY study aims to understand if unusual connections between blood vessels in the brain's covering, called dural arteriovenous fistulae (dAVF), affect the brain's waste-clearing system, known as the glymphatic system. We already know that dAVF can sometimes cause problems with thinking and memory that improve after treatment. This study wants to find out if changes in the glymphatic system are linked to these thinking problems. Patients who are already scheduled to have treatment (embolization) for their dAVF will have special brain MRI scans before and about six months after their treatment. Researchers will compare these scans to see if fixing the dAVF also changes how the brain’s waste-clearing system works.
At a glance
What is this study about?
This study, called COGNIFY (NAIF 2.0), is investigating a condition called a dural arteriovenous fistula (dAVF). This is an uncommon condition where there are abnormal connections between blood vessels (arteries and veins) in the tough outer covering of the brain. While treatment for dAVF usually focuses on preventing serious problems like bleeding in the brain, recent research suggests that dAVF might also affect how well people think and remember things. These thinking problems can sometimes get better after the dAVF is treated.
The main aim of this study is to look at how these dAVFs might affect the brain's natural 'waste disposal' system, known as the glymphatic system. Think of the glymphatic system as a special cleaning service for your brain that helps remove waste products. We believe that the unusual blood flow in a dAVF might disrupt this cleaning process. If the glymphatic system isn't working properly, it could contribute to issues with thinking and memory.
Researchers want to see if treating the dAVF can also improve how the brain's waste-clearing system works. By understanding this better, we might find new ways to help people with dAVF improve their thinking abilities. This study is observational, meaning we will be carefully watching and collecting information from people who are already having treatment, rather than testing new medicines or procedures.
Key takeaways
- The COGNIFY study explores how dAVF might affect the brain's waste-clearing system.
- It uses special MRI scans to compare brain function before and after dAVF treatment.
- Participation involves two extra brain MRI scans over about six months.
- You won't receive new treatments or medicines as part of this study.
- Your medical care for dAVF will continue as planned by your doctors.
- The goal is to understand how dAVF treatment might improve thinking and memory by affecting brain clean-up.
Who may be eligible?
To take part in this study, you would need to be an adult between 18 and 99 years old. You must have been diagnosed with a dural arteriovenous fistula (dAVF) in your brain that hasn't caused any bleeding yet, and your doctors must have decided that you need a specific treatment called 'embolization'. You also need to be well enough to have a brain MRI scan.
There are some reasons why you wouldn't be able to join. For example, if you've recently had bleeding in your brain due to your dAVF, or if you have other serious health problems that the study doctors feel would make it difficult for you to take part. Also, if you have any metal implants that mean you can't have an MRI scan, you wouldn't be able to participate. Your medical team will help decide if this study is right for you.
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 to 99 years old?
- Have you been diagnosed with a dAVF that hasn't caused bleeding?
- Are you already scheduled for dAVF treatment called 'embolization'?
- Can you safely have a brain MRI scan?
- Do you feel well enough to participate in the study?
What does participation involve?
If you decide to take part in the COGNIFY study, you will have a few extra steps alongside your usual medical care. You won't receive any new treatments specifically for the study.
Before your planned dAVF treatment (embolization), you will have a special advanced brain MRI scan. This scan helps researchers understand your brain's waste-clearing system. About six months after your embolization treatment, you will have another one of these special brain MRI scans.
These MRI scans are non-invasive, meaning nothing will be put into your body, and they are generally very safe. The total duration of your participation in the study would be about six months, from your first MRI scan to your follow-up MRI scan.
Potential risks and benefits
Locations (3)
- Università di BolognaVerified postcodeBologna, Italy· Not yet recruiting
- Hospital Universitario Vall D'HebronVerified postcodeBarcelona, Spain· Recruiting
- University of OxfordVerified postcodeOxford, United Kingdom· Not yet recruiting
Common questions
What is a dural arteriovenous fistula (dAVF)?
It's an unusual connection between blood vessels (arteries and veins) in the brain's outer covering.
What is the glymphatic system?
It's like your brain's natural 'waste disposal' system, clearing out waste products.
What is 'embolization' treatment?
It's a procedure to close off the abnormal blood vessel connections in a dAVF, often done by a specialist through a thin tube inserted into a blood vessel.
Will I receive any new treatments by joining this study?
No, you will only have the dAVF treatment your doctors have already planned for you, plus a couple of extra MRI scans for the study.
How long will I be involved in the study?
Your involvement will last about six months, covering the period from your first MRI scan to your follow-up scan after treatment.
How to find out more
Laura Ludovica Gramegna, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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