[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657745":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":32,"studyPopulation":26,"armGroups":33,"interventions":39,"overallOfficials":26,"centralContacts":26,"locations":48,"responsibleParty":70,"collaborators":26,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":26,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":26,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Hennepin Healthcare Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis","A depth electrode is placed through the existing external ventricular drain (EVD) burr hole and used to deliver intracortical stimulation and record cortical reverberation (CR) responses. A participant is counted as meeting the endpoint if ≥24 cumulative hours of CR recording are obtained that pass predefined criteria and are judged suitable for feature extraction.","through study completion, up to two years",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Amplitude of Cortical Reverberation Response","Peak amplitude of the CR response evoked by intracortical stimulation, extracted from the recorded signal by an automated feature-extraction algorithm and reported in microvolts.",{"measure":18,"description":19,"timeFrame":12},"Duration of Cortical Reverberation Response","Duration of the CR response evoked by intracortical stimulation, defined as the interval from response onset to return to baseline, extracted by an automated feature-extraction algorithm and reported in milliseconds.",{"measure":21,"description":22,"timeFrame":12},"Decay Slope of Cortical Reverberation Response","Rate of amplitude decay of the CR response evoked by intracortical stimulation, extracted by an automated feature-extraction algorithm and reported in microvolts per millisecond.",{"measure":24,"description":25,"timeFrame":12},"Latency of Cortical Reverberation Response","Interval from delivery of the intracortical stimulus to onset of the CR response, extracted by an automated feature-extraction algorithm and reported in milliseconds.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":6,"observationalModel":26,"timePerspective":26,"maskingInfo":30},"NA","SINGLE_GROUP",{"masking":31,"maskingDescription":26,"whoMasked":26},"NONE","Traumatic brain injury (TBI) is a major cause of death and disability and imposes burden on the health-system and society. Beyond the first impact of the injury, secondary brain injury processes, include elevated intracranial pressure (ICP), impaired autoregulation, seizures, and cortical spreading depolarizations (CSDs). These effects drive lesion expansion and worsen outcomes. Observational cohorts show that CSDs are common after severe TBI and that higher CSD burden results in worse recovery.\n\nThis is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement. EVDs are required to monitor and manage significant intracranial pressure. During standard-of-care EVD placement at the bedside in the intensive care unit (ICU), a single multi-contact depth electrode will be placed adjacent to the EVD catheter through the same burr hole. The electrode will be connected to a stimulator and recording system. Biphasic, charge-balanced intracortical pulses (1-6 mA, 60-1000 µs) will be delivered between adjacent contacts once every 3 seconds (0.33 Hz) for the duration of monitoring. Continuous electrocorticography (ECoG) will be recorded from the same electrode contacts. Recordings will be reviewed daily by a study neurosurgeon or an epileptologist for evidence of electrographic seizure activity. CR responses will be analyzed offline to assess feasibility, signal quality, and correlation with concurrent physiologic measures obtained from multimodal monitoring. The duration of study monitoring will be determined by the length of time that invasive neuromonitoring is clinically indicated. The depth electrode will be removed at the bedside once EVD monitoring is discontinued or the patient is discharged from the ICU.",[34],{"label":35,"type":6,"description":36,"interventionNames":37},"TBI Patients","This is a single-arm study.",[38],"Device: A multi-contact depth electrode",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DEVICE","A multi-contact depth electrode","Placement of a multi-contact depth electrode through the same burr hole created with a twist drill for clinically indicated EVD placement in TBI patients. The electrode will be positioned adjacent to the EVD catheter and connected to a stimulator\u002Frecording system to deliver biphasic, charge- balanced pulses (1-6 mA, 60-1000 µs) between adjacent contacts less than or equal to once every 3 seconds (0.33 Hz) while recording evoked cortical reverberation responses.",[35],[46,47],"A stimulator\u002Frecording system","Cerestim",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Minneapolis","Minnesota","55415","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-93.26384,44.97997,{"lat":60,"lon":59},[63,68],{"name":64,"role":65,"phone":66,"phoneExt":26,"email":67},"Samuel Cramer, MD, PhD","CONTACT","6128739113","rnl@umn.edu",{"name":64,"role":69,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Samuel Cramer","Principal Investigator","100657745","depth-electrode-cortical-reverberation-monitoring-after-traumatic-brain-injury-100657745",false,"NCT07842458","Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury","Inclusion Criteria:\n\n1. 18 years or older\n2. Consenting party must be able to provide written consent in English\n3. Patient recommended to undergo EVD placement for the monitoring and possible treatment of ICP after TBI\n\nExclusion Criteria:\n\n1. Contaminated scalp lacerations\n2. Known systemic infection\n3. Non-English speaking\n4. Fixed, uncorrectable coagulopathy\n5. Pregnant, minors, or wards of the state","ALL","18 Years",{"count":83,"type":84},15,"ESTIMATED","INTERVENTIONAL",[28],"This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement.",[89],"Traumatic Brain Injury",[91,92,93,94,95,96,97],"traumatic brain injury","brain injury","Cortical Reverberation","Depth Electrode","CSD","cortical spreading depolarization","tbi","2026-09-21",{"date":100,"type":101},"2026-09-25","ACTUAL",{"date":103,"type":101},"2026-05-01",{"date":105,"type":84},"2028-01-30",{"name":72,"class":6},1]