We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

A Non-invasive Intracranial Pressure (nICP) Monitoring System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05632302
Recruitment Status : Completed
First Posted : November 30, 2022
Last Update Posted : November 30, 2022
City, University of London
Barts & The London NHS Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Crainio Ltda

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Intracranial Hypertension Device: nICP Not Applicable

Detailed Description:

Traumatic brain injury (TBI) is the most common cause of death and disability in the under 40 age group both in the United Kingdom and worldwide, and prevalence is increasing. The mainstay of severe TBI management is intracranial pressure (ICP) measurement. ICP is defined as the pressure within the skull and brain. TBI often causes a rise in ICP as the brain swells within the rigid skull and therapy is directed at keeping this pressure at an acceptable level with medications or surgery. Very high ICP may lead to further brain damage resulting in increased disability or death.

Existing techniques to measure ICP involve placing an electrical sensor into the brain tissue through a small hole drilled in the skull. This procedure risks infection and bleeding into the brain and can only be performed by a neurosurgeon. Therefore, there is a vital demand to develop non-invasive technologies that will allow measuring the ICP without inserting a sensor in the brain. This technology will decrease the risks, permit monitoring outside the hospital (eg in an ambulance) and reduce the costs. It will also increase the indication for ICP monitoring to include other conditions (e.g. stroke or brain tumours) which are not currently monitored.

The proposed non-invasive ICP (nICP) monitor works by shining a harmless light into the brain through the skull. The developed sensor was attached to the skin of the forehead and recorded optical signals (known as photoplethysmography (PPG)) from the brain, which are related to changes in the ICP. This pilot aims to build the first clinical database of nICP signals in intensive care patients. The acquisition of an extensive set of signals would allow the generation of advanced algorithms and Machine Learning (ML) models utilising optical signal feature extraction techniques. The resulting model will be implemented in translating the optical signals into absolute measurements of ICP.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Estimate Intracranial Pressure Noninvasively in Traumatic Brain Injury Patients
Actual Study Start Date : January 20, 2020
Actual Primary Completion Date : July 20, 2021
Actual Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TBI-ICP monitoring
Optical signals acquisition from the nICP probe stuck to the patient's forehead
Device: nICP
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.

Primary Outcome Measures :
  1. Machine learning model agreement [ Time Frame: 48 hours record per patient ]
    Bland-Altman limits of agreement between the offline estimation of nICP and the invasive ICP measurements

Secondary Outcome Measures :
  1. Machine learning model diagnostic accuracy [ Time Frame: 48 hours record per patient ]
    Sensitivity and specificity of the offline nICP estimation to identify ICP values over 20 mmHg

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient admitted to the Royal London Hospital who is having invasive ICP monitoring as part of their normal medical care
  • Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent. If the patient is unconscious, and a consultee is not available then a professional consultee (a doctor looking after the patient who is not involved in the trial) will assent to inclusion in the trial and non-invasive ICP monitoring will be performed.

Exclusion Criteria:

  • Patients with decompressive craniectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05632302

Layout table for location information
United Kingdom
Royal London Hospital
London, England, United Kingdom, E1 1BB
Sponsors and Collaborators
Crainio Ltda
City, University of London
Barts & The London NHS Trust
National Institute for Health Research, United Kingdom
Layout table for investigator information
Principal Investigator: Christopher Uff, FRCS Consultant Neurosurgeon (Royal London Hosptial)

Layout table for additonal information
Responsible Party: Crainio Ltda
ClinicalTrials.gov Identifier: NCT05632302    
Other Study ID Numbers: 219476
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the final results of the nICP safety and accuracy would be published. Any individual participant data would be available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Crainio Ltda:
Intracranial pressure
Near infrared spectroscopy
Noninvasive monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries