Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT05632302
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2022-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Non-invasive Intracranial Pressure (nICP) Monitoring System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2022-11-11', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Machine learning model agreement', 'timeFrame': '48 hours record per patient', 'description': 'Bland-Altman limits of agreement between the offline estimation of nICP and the invasive ICP measurements'}], 'secondaryOutcomes': [{'measure': 'Machine learning model diagnostic accuracy', 'timeFrame': '48 hours record per patient', 'description': 'Sensitivity and specificity of the offline nICP estimation to identify ICP values over 20 mmHg'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracranial pressure', 'Near infrared spectroscopy', 'Photoplethysmography', 'Noninvasive monitoring'], 'conditions': ['Traumatic Brain Injury', 'Intracranial Hypertension']}, 'referencesModule': {'references': [{'pmid': '31944644', 'type': 'BACKGROUND', 'citation': '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': '27884843', 'type': 'BACKGROUND', 'citation': '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': '22720148', 'type': 'BACKGROUND', 'citation': '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': '26690122', 'type': 'BACKGROUND', 'citation': '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': '31367614', 'type': 'BACKGROUND', 'citation': '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': '34891522', 'type': 'BACKGROUND', 'citation': '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': '33668311', 'type': 'BACKGROUND', 'citation': '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': '32821023', 'type': 'BACKGROUND', 'citation': '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': '38409283', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nFeatures 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.', 'detailedDescription': '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.\n\nExisting 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted to the Royal London Hospital who is having invasive ICP monitoring as part of their normal medical care\n* 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.\n\nExclusion Criteria:\n\n* Patients with decompressive craniectomy'}, 'identificationModule': {'nctId': 'NCT05632302', 'briefTitle': 'A Non-invasive Intracranial Pressure (nICP) Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Crainio Ltda'}, 'officialTitle': 'A Pilot Study to Estimate Intracranial Pressure Noninvasively in Traumatic Brain Injury Patients', 'orgStudyIdInfo': {'id': '219476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TBI-ICP monitoring', 'description': "Optical signals acquisition from the nICP probe stuck to the patient's forehead", 'interventionNames': ['Device: nICP']}], 'interventions': [{'name': 'nICP', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['TBI-ICP monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1BB', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Christopher Uff, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant Neurosurgeon (Royal London Hosptial)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only the final results of the nICP safety and accuracy would be published. Any individual participant data would be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Crainio Ltda', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'City, University of London', 'class': 'OTHER'}, {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}