protocolSection identificationModule nctId: NCT06368310, orgStudyIdInfo id: R124807, secondaryIdInfos id: 23/WM/0166, type: OTHER, domain: NHS Research Ethics Committee Reference, briefTitle: FIH Clinical Investigation of Graphene Electrodes for Brain Mapping, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Manchester, class: OTHER, collaborators name: Northern Care Alliance NHS Foundation Trust, collaborators name: European Commission, collaborators name: Inbrain Neuroelectronics, descriptionModule briefSummary: The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:* To understand the safety of these new electrodes when used during brain tumor surgery (primary objective);* To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery., conditionsModule conditions: Brain Tumor, conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: INBRAIN Graphene Cortical Interface, outcomesModule primaryOutcomes measure: To evaluate the preliminary safety of the investigational device for its intended use, secondaryOutcomes measure: Assess the ability of the device to record signals from the brain, secondaryOutcomes measure: Evaluate the ability of the device to provide functional stimulation of the brain, secondaryOutcomes measure: Assess stability of sensing and stimulating electrodes, secondaryOutcomes measure: Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery, otherOutcomes measure: Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory), otherOutcomes measure: Assess the quality of the recorded baseline brain activity - sensing part B (exploratory), otherOutcomes measure: Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory), otherOutcomes measure: Evaluate decoding capability from data recorded during language task (exploratory), otherOutcomes measure: Evaluate signal characteristics of tumour infiltrated brain regions (exploratory), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, city: Salford, state: Greater Manchester, zip: M6 8HD, country: United Kingdom, contacts name: Hannah Howlett, role: CONTACT, email: RDResearch@nca.nhs.uk, contacts name: David J Coope, PhD FRCS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.48771, lon: -2.29042, hasResults: False