[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465201":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":61,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":19,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":19,"overallStatus":43,"whyStopped":19,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Cincinnati","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SD-Guided Care","EXPERIMENTAL","In this arm, ECoG data will be reviewed for SDs in real-time using the bedside clinical CNS monitor. As a secondary measure, recognition of SDs will be facilitated by custom software on a laptop that receives data from the CNS monitor. Data on SD occurrence will be used to guide treatment in a tier-based therapeutic escalation and de-escalation protocol with the goal of SD suppression. Therapies to be used among the tiers include adjusted targets for MAP, CPP, PaCO2, plasma glucose, temperature, as well as ketamine pharmacotherapy. Changes between tiers are determined by the success or failure of SD suppression at the given treatment level.",[13,14],"Diagnostic Test: Full-band Electrocorticography","Combination Product: Treatment Algorithm",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard ICU Care","NO_INTERVENTION","Management in the Standard ICU Care arm will follow published national guidelines consisting of common ICU-based targets for physiologic intervention that are thought to mitigate the development of secondary brain injuries.\n\nContinuous ECoG monitoring will be performed for seizure monitoring, but information on the course of SDs in these patients will not be used to guide care. To enforce blinding to SD-related ECoG data, the ECoG bedside software will be locked with password protection to prevent displays with frequency filtering and time\u002Famplitude scales that are necessary to identify SDs.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DIAGNOSTIC_TEST","Full-band Electrocorticography","Diagnosis of spreading depolarizations in continuous electrocorticography",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"COMBINATION_PRODUCT","Treatment Algorithm","Protocol for escalation and de-escalation of physiologic-targeted and pharmacologic therapies to treat and prevent spreading depolarizations",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},"Jed A Hartings, PhD","CONTACT","513-295-2370","jed.hartings@uc.edu",{"name":38,"role":34,"phone":39,"phoneExt":19,"email":40},"Karmen Herzig","513-558-0440","herzigkm@ucmail.uc.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Cincinnati","Ohio","45267","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.51439,39.12711,{"lat":53,"lon":52},[56],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Jed Hartings","Professor",[62,64],{"name":63,"class":6},"University of New Mexico",{"name":65,"class":6},"University of Pennsylvania","100465201","phase-2-improving-neurotrauma-by-depolarization-inhibition-with-combination-therapy-indict-100465201",false,"NCT05337618","Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)","Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial","INDICT","Inclusion Criteria:\n\n(1) clinical indication for emergency craniotomy with dural opening to treat acute TBI within 72 hr post-trauma\n\nExclusion Criteria:\n\n1. persistent bilateral non-reactive pupils or other evidence of non-survivable injury,\n2. decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and\n\n(4) pregnancy","ALL","18 Years","80 Years",{"count":78,"type":79},72,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.",[85],"Traumatic Brain Injury","2025-12-16",{"date":88,"type":89},"2025-12-22","ACTUAL",{"date":91,"type":89},"2022-12-16",{"date":93,"type":79},"2027-03-20",{"name":5,"class":6},1]