Completed

Non-Invasive Intracranial Pressure Monitoring in Traumatic Brain Injury Patients

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What is being tested

nICP

Device
Who is being recruted

Brain Injuries, Traumatic+6

+ Brain Diseases

+ Brain Injuries

Over 16 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: January 2020
See protocol details

Summary

Principal SponsorCrainio Ltda
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 20, 2020

Actual date on which the first participant was enrolled.

Traumatic brain injury (TBI) is a leading cause of death and disability, especially in individuals under 40. A key aspect of managing severe TBI involves monitoring intracranial pressure (ICP), which is the pressure within the skull. High ICP can lead to further brain damage, resulting in increased disability or even death. Currently, ICP measurement involves placing a sensor into the brain tissue, a procedure that carries risks of infection and bleeding, and can only be performed by a neurosurgeon. This study aims to develop a non-invasive method to measure ICP, reducing risks, permitting monitoring outside the hospital, and potentially expanding its use to other conditions like stroke or brain tumors. The proposed non-invasive ICP monitor works by shining a harmless light into the brain through the skull. A sensor attached to the forehead records optical signals known as photoplethysmography (PPG), which are related to changes in ICP. This pilot study aims to create the first clinical database of these signals in intensive care patients. The collected data will help generate advanced algorithms and machine learning models to translate optical signals into absolute ICP measurements. The study's primary outcome is to evaluate the agreement between the non-invasive ICP measurements and traditional invasive methods.

Official TitleA Pilot Study to Estimate Intracranial Pressure Noninvasively in Traumatic Brain Injury Patients
Principal SponsorCrainio Ltda
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain Injuries, TraumaticBrain DiseasesBrain InjuriesCentral Nervous System DiseasesCraniocerebral TraumaNervous System DiseasesWounds and InjuriesIntracranial HypertensionTrauma, Nervous System

Criteria

2 inclusion criteria required to participate
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.

1 exclusion criteria prevent from participating
Patients with decompressive craniectomy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Royal London Hospital

London, United KingdomOpen Royal London Hospital in Google Maps
CompletedOne Study Center