Study of a Non-Invasive Device to Monitor Intracranial Pressure in Adults Undergoing Neurosurgery or Lumbar Puncture

What this Trial Is About

Measuring the pressure inside the skull, known as intracranial pressure ICP, is important for treating serious neurological conditions. Currently, measuring ICP requires an invasive procedure where a monitor is placed inside the skull. Researchers are evaluating a new non-invasive device from Brain4Care that uses a tiny pin placed on the head to detect small skull movements with each heartbeat, producing a waveform similar to invasive ICP measurements. This study aims to understand how this non-invasive ICP monitor waveform changes during standard treatments that lower ICP. The study involves adult patients over 18 who are undergoing brain surgery requiring hyperosmolar agents, those receiving lumbar punctures in neuro-oncology or neurosurgery clinics, or patients with ventriculo-peritoneal shunts needing adjustments. The non-invasive Brain4Care device will be used to monitor ICP waveforms as patients receive their usual care. The device measures skull pulsations to generate a waveform analyzed by factors like the P2P1 ratio and time to peak, which relate to intracranial pressure dynamics. Participants will be observed during their routine clinical care with the non-invasive device monitoring their intracranial pressure waveforms. Researchers will track changes in the P2P1 ratio from enrollment through completion, which may last up to about 100 weeks. The study includes assessments during various ICP-lowering procedures, and participants must be able to consent for themselves. No experimental treatments will be given, and the focus is on gathering data to better understand the devices clinical usefulness.

Non-Invasive ICP Monitoring Study