[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654079":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":58,"studyPopulation":47,"armGroups":59,"interventions":76,"overallOfficials":82,"centralContacts":87,"locations":93,"responsibleParty":109,"collaborators":111,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":47,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":47,"enrollmentInfo":126,"targetDuration":47,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":47,"overallStatus":95,"whyStopped":47,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Yale University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Change in headache days\u002Fweek in the first month","Change in the weekly number of headache days after GON blockade","From one month before to one month after injection",[14,18,21,24,26,28,30,32,35,38,41,44],{"measure":15,"description":16,"timeFrame":17},"Change in headache days\u002Fweek over two months","Change in number of days per week with headache","From one month before to two months after injection",{"measure":19,"description":20,"timeFrame":17},"Change in average headache pain intensity","Intensity on a 0-3 numerical scale (0=none; 1=mild; 2=moderate; 3=severe)",{"measure":22,"description":23,"timeFrame":17},"Change in average attack duration","Hours",{"measure":25,"description":20,"timeFrame":17},"Change in average headache-associated light sensitivity",{"measure":27,"description":20,"timeFrame":17},"Change in average headache-associated sound sensitivity",{"measure":29,"description":20,"timeFrame":17},"Change in average headache-associated nausea\u002Fvomiting",{"measure":31,"description":20,"timeFrame":17},"Change in average headache-associated functional impairment",{"measure":33,"description":34,"timeFrame":17},"Change in average days\u002Fweek using headache abortive treatment","Number of days per week using an abortive treatment for headache",{"measure":36,"description":37,"timeFrame":17},"Patient Global Impression of Change scale (PGIC)","Scale of 1-7 with higher scores indicating worse outcome.",{"measure":39,"description":40,"timeFrame":17},"Migraine-Specific Quality of Life questionnaire (v2.1) (MSQ)","0-to-100 scale. Higher scores indicate better quality of life.",{"measure":42,"description":43,"timeFrame":17},"Migraine Disability Assessment (MIDAS)","Score from 0 to 270. Higher scores indicating more severe disability.",{"measure":45,"description":46,"timeFrame":17},"Number of participants with Adverse events","Number of participants with Adverse events that occur during or after injection",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":54},"TRIPLE",[55,56,57],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Military Servicemembers are at elevated risk for traumatic brain injury (TBI) and its consequences, including post-traumatic headache (PTH). The most common phenotype of PTH is migraine, for which there are numerous potential treatments, though these have limitations, including poor efficacy, drug-drug interactions, and intolerable side effects. Therefore, the consideration of other methods to manage PTH in Servicemembers and Veterans is warranted.\n\nAnesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects in a variety of headache disorders. This intervention is frequently done to provide immediate relief, followed by a period of reduced headache burden.\n\nIn this second portion of this study, Veterans with chronic post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks. They will maintain a headache diary to measure the change in headache frequency over the two months after injection. This design uses information gathered from sub-study 1 of this project (NCT#06069791). In that initial intervention, different concentrations of bupivacaine were examined to consider the intensity and spread of acute and subacute sensations that occur with GON blockade. This allowed us to select a low dose (0.05%) that approximates the sensations of the full dose of 0.5%.",[60,66,71],{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo","PLACEBO_COMPARATOR","0.0% bupivacaine (normal saline)",[65],"Drug: Bupivacaine bilateral greater occipital nerve block",{"label":67,"type":68,"description":69,"interventionNames":70},"Low dose bupivacaine","ACTIVE_COMPARATOR","0.05% bupivacaine",[65],{"label":72,"type":73,"description":74,"interventionNames":75},"Full dose bupivacaine","EXPERIMENTAL","0.5% bupivacaine",[65],[77],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":47},"DRUG","Bupivacaine bilateral greater occipital nerve block","Three subcutaneous injections of 1 mL each will be injected on both sides of the occipital region around the greater occipital nerve.",[72,67,61],[83],{"name":84,"affiliation":85,"role":86},"Emmanuelle Schindler, MD, PhD","VA Connecticut Healthcare System","PRINCIPAL_INVESTIGATOR",[88],{"name":84,"role":89,"phone":90,"phoneExt":91,"email":92},"CONTACT","203-932-5711","14335","emmanuelle.schindler@va.gov",[94],{"facility":85,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"RECRUITING","West Haven","Connecticut","06516","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-72.94705,41.27065,{"lat":105,"lon":104},[108],{"name":84,"role":89,"phone":90,"phoneExt":91,"email":92},{"type":110,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[112,114],{"name":85,"class":113},"FED",{"name":115,"class":116},"National Headache Foundation","UNKNOWN","100654079","phase-1-greater-occipital-nerve-blockade-in-veterans-with-post-concussion-headache-sub-study-2-100654079",false,"NCT07796074","Greater Occipital Nerve Blockade in Veterans With Post-concussion Headache: Sub-study 2","Anesthetic Greater Occipital Nerve Blockade in Veterans With Post-Traumatic Headache: Sub-study 2","Inclusion Criteria:\n\n* United States Military Veterans within VA Connecticut Healthcare System1.\n* Head injury with headaches that have continued to occur for at least three months after the head injury\n* At least two headache days per week\n* Review of the medical record does not reveal another source for headache\n\nExclusion Criteria:\n\n* Skull defect\n* Other contraindication to bupivacaine\n* Allergy or adverse reaction (e.g., rash, cardiac effects) to amide anesthetics, such as lidocaine\n* Instruction from clinician to avoid amide anesthetics, such as lidocaine\n* Pregnant or lack of adequate birth control\n* Clinical review of the patient's case reveals red flag signs or symptoms (e.g., side-locked pain, unilateral numbness\u002Fweakness during headache, rapid ascension to peak pain, syncope during attacks) that warrant further work-up (e.g., MRI, arterial imaging).\n* Absence of imaging warranted by the standard of clinical care for the head injury with headaches.","ALL","18 Years",{"count":127,"type":128},36,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","Anesthetic greater occipital nerve (GON) blockade is a simple, inexpensive, and safe procedure that has demonstrable headache pain suppressing effects. In this study, Veterans with post-traumatic headache will be randomized to receive 0.0%, 0.05%, or 0.5% bupivacaine in bilateral GON blocks and the lasting (i.e., transitional) effects on headache frequency measured in a headache diary.",[134],"Post-Traumatic Headache","2026-09-02",{"date":137,"type":138},"2026-09-08","ACTUAL",{"date":140,"type":128},"2026-09-01",{"date":142,"type":128},"2027-12-31",{"name":5,"class":6},1]