[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562831":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":59,"centralContacts":63,"locations":70,"responsibleParty":119,"collaborators":122,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":68,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":68,"enrollmentInfo":137,"targetDuration":68,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":73,"whyStopped":68,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A =Stellate ganglion block (SGB) with bupivacaine (LA) plus placebo ketamine (midazolam)","ACTIVE_COMPARATOR","Stellate ganglion block with the local anesthetic (LA) bupivacaine and placebo (1-7 mg midazolam + normal saline) ketamine.\n\nThe stellate ganglion block will be performed with approximately 8 mL bupivacaine using ultrasound or fluoroscopic guidance. The placebo ketamine will consist of an initial 1-4 mg bolus of midazolam followed by boluses or an infusion (in normal saline) of midazolam up to 7 mg, over 30-60 minutes.",[13],"Procedure: Group A active comparator",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B = Sham SGB plus ketamine infusion","Sham SGB will be 1-2 mL of saline given subcutaneously using ultrasound or fluoroscopic guidance. The ketamine will consist of Prior to the sham Stellate Ganglion Block procedure, the study drug ketamine or normal saline will be administered by one of the study team physicians. 100 ml bag will be administered by bolus\u002Finfusion or intermittent boluses up to 0.3 mg\u002Fkg). The ketamine infusion will start before the sham block where patients will be given 1-4 mg of midazolam + up to 0.3 mg\u002Fkg of ketamine, as bolus doses. Over the next 30-60 minutes patients will receive between 0.5-1 mg\u002Fkg total dose of ketamine, + additional midazolam as needed.",[18],"Drug: Group B active comparator",{"label":20,"type":21,"description":22,"interventionNames":23},"Group C = Stellate ganglion block (SGB) with bupivacaine LA plus ketamine infusion","EXPERIMENTAL","These patients will receive both SGB with bupivacaine + ketamine as described above.",[24],"Combination Product: Group C Experimental",{"label":26,"type":27,"description":28,"interventionNames":29},"Group D = Sham SGB plus placebo ketamine (midazolam)","PLACEBO_COMPARATOR","These patients will receive the sham SGB + placebo ketamine as described above.",[30],"Other: Group D Placebo Comparator",[32,39,46,53],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Group A active comparator","Group A placebo comparator. Stellate Ganglion Block plus placebo (.9 normal saline) infusion",[9],[38],"Group A",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Group B active comparator","Active Comparator: Group B = Sham Stellate Ganglion Block plus ketamine infusion",[15],[45],"Group B",{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"COMBINATION_PRODUCT","Group C Experimental","Group C experimental Stellate Ganglion Block plus ketamine infusion",[20],[52],"Group C",{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Group D Placebo Comparator","Group D Placebo Comparator: Sham Stellate Ganglion Block plus placebo normal saline",[26],[58],"Group D",[60],{"name":61,"affiliation":5,"role":62},"Steven Cohen, MD","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":68,"email":69},"Jordan Wood, BS","CONTACT","312-695-0915",null,"jordan.wood1@northwestern.edu",[71,88,103],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Anesthesiology Pain Medicine Center","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-87.65005,41.85003,{"lat":83,"lon":82},[86],{"name":87,"role":66,"phone":67,"phoneExt":68,"email":69},"Jordan Wood",{"facility":89,"status":73,"city":90,"state":91,"zip":92,"country":77,"countryCode":78,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Walter Reed National Military Medical Center","Bethesda","Maryland","20889",{"type":80,"coordinates":94},[95,96],-77.10026,38.98067,{"lat":96,"lon":95},[99],{"name":100,"role":66,"phone":101,"phoneExt":68,"email":102},"Elsa Ermer, PhD","301-550-0507","crsr_research@usuhs.edu",{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":77,"countryCode":78,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Womack Army Medical Center","NOT_YET_RECRUITING","Fort Bragg","North Carolina","28310",{"type":80,"coordinates":110},[111,112],-79.00603,35.139,{"lat":112,"lon":111},[115],{"name":116,"role":66,"phone":117,"phoneExt":68,"email":118},"Min H Chang, MD","910-643-2310","min.h.chang.mil@health.mil",{"type":62,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":68,"oldOrganization":68},"Steven Cohen","Principal Investigator",[123,125,127],{"name":89,"class":124},"FED",{"name":126,"class":6},"Lviv National Medical University",{"name":104,"class":124},"100562831","phase-2-ketamine-sgb-and-combination-treatment-for-tbi-associated-headache-or-ptsd-100562831",false,"NCT06608277","Ketamine, SGB and Combination Treatment for TBI-associated Headache or PTSD","Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Ketamine, Stellate Ganglion Blocks and Combination Treatment to Sham Therapies for Traumatic Brain Injury-Associated Headaches and Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Adults 18 years or older\n2. Stable doses of medications for \\> 2 weeks for TBI and\u002For PTSD\n3. For TBI-associated headache with or without PTSD: HIT-6 score of \\>\u002F=53. For PTSD with or without TBI-associated headache: PCL-5 score \\>\u002F=33 OR. For those with TBI and PTSD, and a HIT-6 score \\\u003C 53 and PCL-5 score of \\\u003C33, individuals with a HIT-6 score of 50-52 and a PCL-5 score of 31 or 32 will be included.\n4. Duration of chronic TBI or PTSD \\> 3 months\n\nExclusion Criteria:\n\n1. Ketamine infusion or SGB within the past 6 months\n2. Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)\n3. Elevated intracranial pressure\n4. For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI)\n5. Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder)\n6. Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina)\n7. Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test)\n8. Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)","ALL","18 Years",{"count":138,"type":139},175,"ESTIMATED","INTERVENTIONAL",[142],"PHASE2","Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios.\n\nPrimary Objectives:\n\n1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache;\n2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD;\n3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD;\n4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance;\n5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.\n\nSecondary Objectives:\n\n1. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance (Biomedical levels and MRI not included at Northwestern University Site).\n2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.",[145,146],"Posttraumatic Headache","Posttraumatic Stress Disorder",[148,149],"Ketamine","Stellate Ganglion Block","2026-04-27",{"date":152,"type":153},"2026-05-01","ACTUAL",{"date":155,"type":153},"2025-07-02",{"date":157,"type":139},"2028-04-30",{"name":5,"class":6},3]