RecruitingNAINTERVENTIONAL

Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein

This study is investigating a new, less invasive way to check the pressure inside your head, known as intracranial pressure (ICP). Currently, measuring ICP often involves needles and carries risks like infection. This research aims to see if we can get similar information by measuring the pressure in a small vein near your eye, using a simple, non-invasive method. The study involves people who are already scheduled to have a regular diagnostic test that measures spinal fluid pressure. During this standard test, researchers will also use the new eye vein pressure method. The goal is to compare results and find out if this gentler approach could be a reliable way to monitor ICP in the future, making it safer and more comfortable for patients.

At a glance

Status

Recruiting

Phase

Sponsor

University of Freiburg

Enrolment target

Start

07 Apr 2025

Estimated completion

08 Dec 2025

Indication for CSF Dynamic Testing Indication for CSF Infusion Test

What is this study about?

When the pressure inside your head (called intracranial pressure, or ICP) gets too high, it can be a serious medical issue. High pressure can happen for various reasons, like brain injuries, strokes, or certain conditions affecting the brain. Doctors need to monitor this pressure to make sure your brain stays healthy and to guide treatments. Currently, the most accurate ways to measure this pressure involve procedures that go inside your head or spine, which, while necessary, carry some risks like infection or discomfort.

This study is looking for a much gentler way to check this important pressure. The idea is to see if we can get useful information by simply measuring the blood pressure in a tiny blood vessel (a vein) near your eye. Think of it like taking your blood pressure on your arm, but in a different spot. Researchers will be comparing this new, simple measurement with the readings from the standard, more invasive tests to see if they match up.

Ultimately, if this new method proves to be accurate, it could change how doctors monitor brain pressure. It could mean fewer invasive procedures for patients, leading to less pain, discomfort, and fewer risks. This research is a step towards making medical care safer and more comfortable for people needing their brain pressure checked.

Key takeaways

This study is testing a non-invasive way to measure pressure inside your head.
It aims to make future brain pressure monitoring safer and more comfortable.
Participation happens during an already scheduled diagnostic test.
The new method involves a gentle measurement near your eye with a face mask.
There are very few risks, mostly minor discomfort from the mask.

Who may be eligible?

To join this study, you need to be an adult between 18 and 95 years old. You must already be scheduled to have a routine medical test called a "CSF dynamic test" or "CSF infusion test" because your doctor thinks it's necessary for your health. This is a standard test that measures the pressure of the fluid around your brain and spinal cord.

There are some reasons why you wouldn't be able to join. For example, if you've had certain brain or spinal cord surgeries, injuries, or conditions that affect the fluid around your brain within the last six months, or if you have any conditions that would make it hard to measure the pressure near your eye, then this study might not be suitable 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 between 18 and 95 years old?
Are you already scheduled for a routine CSF dynamic or infusion test?
Do you feel comfortable giving your permission to take part?
Have you *not* had certain brain/spinal fluid surgeries or injuries in the last 6 months?
Do you *not* have head wounds or conditions that would block access to the area around your eye?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't need any extra hospital visits beyond what you're already scheduled for. The additional steps for this study will happen during your existing CSF dynamic test. While you're lying down for that test, we'll gently place a small pneumatic mask over part of your face. This mask will be used to take some measurements of the veins near your eye. An investigator will show you how it works and then take a few measurements. You'll be asked if this process causes any discomfort.

This measurement will happen at the same time as your routine procedure, so it won't add much extra time. The study doesn't involve any new medications, and there's no long-term follow-up required after your initial test day. Your total participation in the study itself would only be during that single appointment for your CSF dynamic test.

Potential risks and benefits

Taking part in this study won't directly improve your health, but it could help doctors in the future find better ways to monitor brain pressure, which might benefit many other patients. The main potential benefit is contributing to medical knowledge. There are very few risks associated with the study itself, as the new measurement method is non-invasive and performed alongside your planned procedure. You might feel some minor pressure or mild discomfort from the face mask during the brief measurement. Remember, participating is completely voluntary, and you are free to change your mind and withdraw from the study at any time without affecting your medical care.

Locations (1)

Klinik für Neurochirurgie, Universitätsklinikum Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What is intracranial pressure (ICP)?

It's the pressure inside your skull that surrounds your brain. Keeping it at a normal level is very important for brain health.

Why is this study important?

It's trying to find a simpler, non-invasive way to check brain pressure, which could make monitoring safer and more comfortable for patients in the future.

Will I get any specific treatment for being in the study?

No, this study is about a new measurement technique, not a new treatment. You will still receive your regular medical care and tests as planned.

Will the study add time to my hospital visit?

The new measurement will happen alongside your scheduled CSF dynamic test, so it should only add a very small amount of time to that appointment.

Does it involve any needles or cuts?

The study's new measurement technique itself is non-invasive and uses a mask. Your routine CSF test, however, does involve needles as part of standard care.

How to find out more

Katharina Wolf

katharina.wolf@uniklinik-freiburg.de +4976127050010 Official trial record

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