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Crainio Non-invasive ICP Monitor for TBI

RecruitingNAAges 16 Years - 99 YearsAllCrainio Ltda
NCT06453733 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The clinical investigation aims to advance the Crainio device, designed for non-invasive intracranial pressure (ICP) monitoring. This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury. The primary objective is to establish the diagnostic accuracy of the Crainio device, aiming for at least 90% sensitivity and specificity in detecting raised ICP (above 20 mmHg). Secondary objectives include evaluating patient-related factors such as skin tone, skull thickness, and skull density, as well as the tolerability and acceptance of the device by both patients and healthcare professionals.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Clinical diagnosis of traumatic brain injury. * Adults (aged between 16 and 99, male and female) * TBI patients admitted to the Royal London Hospital. * Patients having invasive ICP monitoring as part of their normal medical treatment. Exclusion Criteria: * Forehead skin is not intact. * Decompressive craniectomy patients. * Open external ventricular drainage (EVD) treatment. * Patients who will unlikely survive the following twelve hours.
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What it tests

  • Crainio
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Where

1 site
Royal London Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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