Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
Study NCT ID:
NCT06409806
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D002545', 'term': 'Brain Ischemia'}], 'ancestors': [{'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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-05-01', 'studyFirstSubmitQcDate': '2024-05-07', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow.', 'timeFrame': 'Over a 28 month period from November 2022 to March 2026', 'description': 'The primary outcome is to report the feasibility of integrating the ECoG brain retractor into standard traditional neurosurgical operative workflow based upon analysing prospective data including qualitative questionnaires administered to surgeons and scrub nurses, anonymised clinical data, and anonymised electrophysiological data.\n\nThe primary outcome is to produce a descriptive report of the electrophysiological data recorded and the challenges encountered in the delivery of the novel electrophysiological recording for patients undergoing planned neurosurgical procedures at the National Hospital for Neurology and Neurosurgery, London.'}], 'secondaryOutcomes': [{'measure': 'Analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction.', 'timeFrame': 'Over a 28 month period from November 2022 to March 2026', 'description': 'The secondary objective is to analyse the captured electrophysiological data to investigate any correlation between the electrophysiological signature and duration of retraction. Post-operative clinical data, such as MRI brain scans, can be reviewed to investigate any ischemic events.\n\nWe will perform an initial analysis of the electrophysiological data to see if neurophysiological stigmata of brain retraction injury can be identified, with the operation simultaneous recorded with the operative microscope.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain retraction'], 'conditions': ['Brain Injury', 'Neurosurgery', 'Brain Ischemia']}, 'descriptionModule': {'briefSummary': 'A single centre IDEAL Stage 1 feasibility study using novel electrophysiological recording techniques in adult participants undergoing neurosurgery. This is a first in human study, building upon previous preclinical mice experiments.\n\nParticipants will undergo their planned neurosurgical procedure as normal. In addition to their standard treatment neurophysiological monitoring including an electrocorticography electrode placed on the brain deep to the retractor will be used to monitor for signs of brain retraction injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 16 or older undergoing intracranial surgery where it is anticipated fixed brain retraction will be used.\n\nExclusion Criteria:\n\n* Patients without capacity to give consent at time of recruitment'}, 'identificationModule': {'nctId': 'NCT06409806', 'acronym': 'EMBRI', 'briefTitle': 'Electrocorticographic Monitoring of Brain Retraction Injury (EMBRI)', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Electrocorticography As a Neurophysiological Marker for Intraoperative Monitoring for Brain Retraction: an IDEAL Stage 1 Study', 'orgStudyIdInfo': {'id': '310742'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'interventionNames': ['Other: ECOG Array']}], 'interventions': [{'name': 'ECOG Array', 'type': 'OTHER', 'description': 'The patient will undergo their intracranial neurosurgical procedure as planned, using conventional brain retractors and neurosurgical equipment.\n\nStandard neuromonitoring (EEG, MEP, SSEP) will be placed after the induction of neuroanaesthesia if indicated. Additional to whatever conventional EMBRI neuromonitoring is used, intraoperatively an ECoG array will be positioned under the retractor by the operating surgeon. Further electrode arrays may be placed on the cortical surface remote from the retractor as needed to establish a reference.\n\nTypically we anticipate one ECoG array under the retractor blade with a reference array on an area of unretracted brain.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 3BG', 'city': 'London', 'state': 'Greater London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Siddharth Sinha', 'role': 'CONTACT', 'email': 'siddharth.sinha@ucl.ac.uk'}], 'facility': 'National Hospital Neurology and Neurosurgery', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Siddharth Sinha', 'role': 'CONTACT', 'email': 'siddharth.sinha@ucl.ac.uk', 'phone': '004420 3456 7890'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}