Crainio non-invasive intracranial pressure monitor for traumatic brain injury
Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 16 Years to 99 Years |
| Sex | All |
| Sponsor | Crainio Ltda Industry-sponsored |
| Locations | 1 site (London, England) |
| Trial ID | NCT06453733 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London, England
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.