Crainio non-invasive intracranial pressure monitor for traumatic brain injury
Official title: Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development
Run by Crainio Ltda · NCT06453733 · Data updated 2026-11-12
This project will test whether the Crainio device can non‑invasively detect raised intracranial pressure in adults with traumatic brain injury by comparing its readings to standard invasive monitors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 99 Years |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Crainio Ltda Industry-sponsored |
| Locations | 1 site (London, England) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | May 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT06453733 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 16–99 with traumatic brain injury admitted to the Royal London Hospital who are receiving invasive ICP monitoring and have intact forehead skin are eligible.
✕Probably not a fit
Patients with decompressive craniectomy, open external ventricular drains, non‑intact forehead skin, or who are not expected to survive the next 12 hours are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility study will enroll 54 adults with traumatic brain injury who already have invasive ICP monitoring, collecting cerebral photoplethysmogram signals concurrently with invasive ICP measurements over a 12‑month period. The collected data will be used to train and validate Crainio machine learning algorithms to detect raised ICP (>20 mmHg) with a target of at least 90% sensitivity and specificity. Secondary analyses will examine how factors like skin tone, skull thickness and density affect signal quality, and will record device tolerability and staff acceptance. The work is conducted at the Royal London Hospital in collaboration with academic and funding partners and focuses on developing a continuous external nICP monitoring approach.
Why it matters
Potential benefit: If successful, the device could provide continuous non‑invasive ICP monitoring that reduces the need for invasive bolts or ventricular catheters and their associated risks.
How similar studies have gone: Prior non‑invasive ICP approaches (e.g., transcranial Doppler, retinal vein measures) have produced mixed, largely non‑continuous results, and continuous PPG‑based machine‑learning methods like Crainio remain relatively novel and unproven clinically.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Royal London Hospital
London, England, United Kingdom Recruiting
Study contacts
- Principal investigator: Chris Uff, Dr — Barts & The London NHS Trust
- Study coordinator: Jeremy Holland, Dr
- Email: Jeremy.Holland@crainio.com
- Phone: 0779 626 5994
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.