Crainio Non-invasive ICP Monitor for TBI

NCT06453733 | Recruiting DMC

• 1 other identifier: 341050
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Intracranial pressure; Non-invasive monitoring; Machine learning; Photoplethysmography

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Generate a nICP model offline with a sensitivity above 90% to discriminate ICP values over 20 mmHg.

  12 hours record per patient

• Specificity

  Generate a nICP model offline with a specificity above 90% to discriminateICP values over 20 mmHg.

  12 hours record per patient

Secondary Outcomes (5)

• Skin tone through Fitzpatrick scale

  1 classification per patient (3 minutes)

• Skull thickness through CT scan

  1 measurement per patient (3 minutes)

• Skull density through Age stratification analysis

  1 classification per patient (1 minute)

• Device usability

  1 form per patient (5 minutes)

• Advers effects and events

  12 hours record per patient

Study Arms (1)

Crainio

EXPERIMENTAL

Acquisition of cerebral PPG signals from Crainio's probe stuck to the patient's forehead, alongside concurrent invasive ICP measurements in patients with traumatic brain injury

Device: Crainio

Interventions

Crainio DEVICE

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.

Also known as: nICP probe, Crainio system

Crainio

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Forehead skin is not intact.
• Decompressive craniectomy patients.
• Open external ventricular drainage (EVD) treatment.
• Patients who will unlikely survive the following twelve hours.

Sponsors & Collaborators

• Crainio Ltda: lead
• Innovate UK: collaborator
• Barts & The London NHS Trust: collaborator
• City, University of London: collaborator

Study Sites (1)

Royal London Hospital

London, England, E1 1BB, United Kingdom

RECRUITING

Related Publications (9)

• Roldan M, Kyriacou PA. Near-Infrared Spectroscopy (NIRS) in Traumatic Brain Injury (TBI). Sensors (Basel). 2021 Feb 24;21(5):1586. doi: 10.3390/s21051586.

  PMID: 33668311 BACKGROUND

• Roldan M, Abay TY, Kyriacou PA. Non-Invasive Techniques for Multimodal Monitoring in Traumatic Brain Injury: Systematic Review and Meta-Analysis. J Neurotrauma. 2020 Dec 1;37(23):2445-2453. doi: 10.1089/neu.2020.7266. Epub 2020 Sep 24.

  PMID: 32821023 BACKGROUND

• Roldan M, Chatterjee S, Kyriacou PA. Brain Light-Tissue Interaction Modelling: Towards a non-invasive sensor for Traumatic Brain Injury. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:1292-1296. doi: 10.1109/EMBC46164.2021.9630909.

  PMID: 34891522 BACKGROUND

• Roldan M, Kyriacou PA. Head Phantom Optical Properties Validation for Near-Infrared Measurements: A Comparison with Animal Tissue. Annu Int Conf IEEE Eng Med Biol Soc. 2022 Jul;2022:641-644. doi: 10.1109/EMBC48229.2022.9871103.

  PMID: 36085774 BACKGROUND

• Roldan M, Bradley GRE, Mejia-Mejia E, Abay TY, Kyriacou PA. Non-invasive monitoring of intracranial pressure changes: healthy volunteers study. Front Physiol. 2023 Aug 8;14:1208010. doi: 10.3389/fphys.2023.1208010. eCollection 2023.

  PMID: 37614754 BACKGROUND

• Roldan M, Abay TY, Uff C, Kyriacou PA. A pilot clinical study to estimate intracranial pressure utilising cerebral photoplethysmograms in traumatic brain injury patients. Acta Neurochir (Wien). 2024 Feb 27;166(1):109. doi: 10.1007/s00701-024-06002-4.

  PMID: 38409283 BACKGROUND

• M. Roldan and P. A. Kyriacou, Head Phantom for the Acquisition of Pulsatile Optical Signals for Traumatic Brain Injury Monitoring, Photonics, vol. 10, no. 5, 2023

  BACKGROUND

• T. Y. Abay, J. P. Phillips, C. Uff, M. Roldan, and P. A. Kyriacou, In Vitro Evaluation of a Non-Invasive Photoplethysmography Based Intracranial Pressure Sensor, Appl. Sci., vol. 13, no. 1, p. 534, Dec. 2022

  BACKGROUND

• M. Roldan and P. A. Kyriacou, "A non-Invasive Optical Multimodal Photoplethysmography-Near Infrared Spectroscopy Sensor for Measuring Intracranial Pressure and Cerebral Oxygenation in Traumatic Brain Injury," Appl. Sci., 2023

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chris Uff, Dr

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Holland, Dr

CONTACT

0779 626 5994; Jeremy.Holland@crainio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 12, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)