A Non-invasive Intracranial Pressure (nICP) Monitoring System

NCT05632302 | Completed

• 1 other identifier: 219476
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously. This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available. The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment. Features of the optical signals would be analysed offline. A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.

Conditions

Traumatic Brain Injury; Intracranial Hypertension

Keywords

Intracranial pressure; Near infrared spectroscopy; Photoplethysmography; Noninvasive monitoring

Outcome Measures

Primary Outcomes (1)

• Machine learning model agreement

  Bland-Altman limits of agreement between the offline estimation of nICP and the invasive ICP measurements

  48 hours record per patient

Secondary Outcomes (1)

• Machine learning model diagnostic accuracy

  48 hours record per patient

Study Arms (1)

TBI-ICP monitoring

EXPERIMENTAL

Optical signals acquisition from the nICP probe stuck to the patient's forehead

Device: nICP

Interventions

nICP DEVICE

The nICP probe contains infrared light sources that illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries.

TBI-ICP monitoring

Eligibility Criteria

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

You may qualify if:

• Patient admitted to the Royal London Hospital who is having invasive ICP monitoring as part of their normal medical care

You may not qualify if:

• Patients with decompressive craniectomy

Sponsors & Collaborators

• Crainio Ltda: lead
• City, University of London: collaborator
• Barts & The London NHS Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal London Hospital

London, England, E1 1BB, United Kingdom

Location

Related Publications (9)

• Head injury: assessment and early management. London: National Institute for Health and Care Excellence (NICE); 2019 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK552670/

  PMID: 31944644 BACKGROUND

• Lawrence T, Helmy A, Bouamra O, Woodford M, Lecky F, Hutchinson PJ. Traumatic brain injury in England and Wales: prospective audit of epidemiology, complications and standardised mortality. BMJ Open. 2016 Nov 24;6(11):e012197. doi: 10.1136/bmjopen-2016-012197.

  PMID: 27884843 BACKGROUND

• Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8.

  PMID: 22720148 BACKGROUND

• Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146.

  PMID: 26690122 BACKGROUND

• Nag DS, Sahu S, Swain A, Kant S. Intracranial pressure monitoring: Gold standard and recent innovations. World J Clin Cases. 2019 Jul 6;7(13):1535-1553. doi: 10.12998/wjcc.v7.i13.1535.

  PMID: 31367614 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. 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, 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 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Uff, FRCS

  Consultant Neurosurgeon (Royal London Hosptial)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 30, 2022
• Study Start: January 20, 2020
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)