Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolat… (NCT07053631) | Clinical Trial Compass
RecruitingNot Applicable
Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein
Germany10 participantsStarted 2025-04-07
Plain-language summary
Elevated intracranial pressure (ICP) occurs when pressure inside the skull rises above normal levels, potentially leading to brain damage or herniation. Monitoring ICP is critical for managing conditions like brain tumors, traumatic brain injury, and stroke. Current ICP monitoring methods are invasive and carry risks, including infection and brain damage. For less severe cases, lumbar puncture is a safer, less invasive alternative. This study explores the potential of a non-invasive method, using venous pressure near the eye, to estimate ICP. The goal is to assess whether the results from this non-invasive approach are similar to the invasive lumbar CSF pressure measurements.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Medical indication to perform routine craniospinal CSF dynamic testing according to standard operative procedures
* Aged 18-95
* Willing and able to provide valid signed informed consent
Exclusion Criteria:
* Patients with any known ongoing, or history of, abnormal CSF communication
* Patients with any kind of prior intervention for CSF diversion
* Patients with acute brain damage within the preceding 6 months
* Patients with transdural surgery within the preceding 6 months
* Head wounds or hematoma that could hinder access to measurement site
* Any known pathological condition linked to the orbital socket influencing venous outflow
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.