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RECRUITINGINTERVENTIONAL

Crainio Non-invasive ICP Monitor for TBI

Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Forehead skin is not intact. - Decompressive craniectomy patients. - Open external ventricular drainage (EVD) treatment. - Patients who will unlikely survive the following twelve hours. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Crainio

Crainio device comprises a forehead-mounted sensor containing infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the sensor detect the backscattered light, which is modulated by pulsation of the cerebral arteries. A control unit processes the backscattered light (called the photoplethysmogram, PPG) and transmits it to a computer device to train ML models that will estimate ICP offline.

Locations (1)

Royal London Hospital
London, England, United Kingdom