In current practice patients with a suspected increase of intracranial pressure (ICP) will undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal
Who can participate
Age range
18 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:
* Male or Female in the age range of 18 years and older
* All patients who are referred for elective or subacute lumbar puncture including CSF pressure measurement
Exclusion Criteria:
* Local infection in the ear
* Pregnant or lactating women
* Cervical spine stenose
* Arnold-Chiari malformations
* Aqueductal stenosis or other changes causing an uneven CSF pressure between different compartments
* Mass lesions
* Current or previous craniotomy or craniectomies
* Suspicion of meningitis or encephalitis
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.
1Since this trial is comparing the HeadSense non-invasive monitor against lumbar CSF pressure measurement, can you help me understand how accurate the HeadSense device has shown to be so far, and whether that level of accuracy would be good enough for managing my condition?
2The trial's recruitment status is listed as unknown — do you know whether this study is still actively enrolling patients, or if it has wrapped up, and where that leaves my options for accessing this kind of non-invasive monitoring?
3This study is listed as Phase NA, which suggests it's more of a device validation study than a treatment trial — does that mean there's no direct treatment benefit to me if I participate, and I'd mainly be helping researchers test a new monitoring tool?
4Right now, how is my intracranial pressure being monitored, and if the HeadSense device isn't yet validated as a standard tool, would participating in this trial change anything about my actual care plan?
5Are there any risks involved in the lumbar CSF pressure measurement that's being used as the comparison standard in this trial, and is that procedure something I'd have to undergo specifically because of participating?
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.
What they're measuring
1
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards