Crainio Non-invasive ICP Monitor for TBI

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Sensitivity — 12 hours record per patient
  Generate a nICP model offline with a sensitivity above 90% to discriminate ICP values over 20 mmHg.
• Specificity — 12 hours record per patient
  Generate a nICP model offline with a specificity above 90% to discriminateICP values over 20 mmHg.

Trial sites (1)