Actively Recruiting
Crainio Non-invasive ICP Monitor for TBI
Led by Crainio Ltda · Updated on 2026-03-18
54
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
C
Crainio Ltda
Lead Sponsor
I
Innovate UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Crainio Non-invasive ICP Monitor for TBI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of traumatic brain injury.
- Adults aged between 16 and 99 years.
- Admission to the Royal London Hospital.
- Patients receiving invasive intracranial pressure monitoring as part of normal care.
You will not qualify if you...
- Forehead skin is not intact.
- Patients who have undergone decompressive craniectomy.
- Patients receiving open external ventricular drainage treatment.
- Patients unlikely to survive the next twelve hours.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal London Hospital
London, England, United Kingdom, E1 1BB
Actively Recruiting
Research Team
J
Jeremy Holland, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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