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A Non-invasive Intracranial Pressure (nICP) Monitoring System

NCT05632302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • City, University of London

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Crainio Ltda

    lead INDUSTRY

Principal Investigators

  • Christopher Uff, FRCS · Consultant Neurosurgeon (Royal London Hosptial)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-07-20
Completion
2021-07-20

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632302 on ClinicalTrials.gov