protocolSection identificationModule nctId: NCT06368648, orgStudyIdInfo id: CP-1, briefTitle: CoMind Early Feasibility Study, acronym: CoMind EFS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: CoMind Technologies Limited, class: INDUSTRY, collaborators name: Lindus Health, descriptionModule briefSummary: The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP., conditionsModule conditions: Intracranial Pressure, conditions: Intracranial Pressure Changes, conditions: Traumatic Brain Injury, conditions: Intracerebral Hemorrhage, conditions: Encephalitis, conditions: Encephalopathy, conditions: Hydrocephalus, conditions: Stroke, conditions: Autoregulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 581, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP, primaryOutcomes measure: Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP., secondaryOutcomes measure: Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population., secondaryOutcomes measure: Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg)., secondaryOutcomes measure: Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform., secondaryOutcomes measure: Demonstration of an non-invasive ICP model that can predict trends in ICP, otherOutcomes measure: A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False