[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623924":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":47,"overallOfficials":53,"centralContacts":58,"locations":67,"responsibleParty":84,"collaborators":33,"id":86,"slug":33,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":33,"studyType":99,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":70,"whyStopped":33,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"The University of Texas Medical Branch, Galveston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety of Bipolar external carotid artery circulation Stimulation","Safety will be evaluated based on the ability to complete the stimulation procedure without technical failure, serious complications, or procedure-related neurological deficits.","Measured Perioperative\u002FPeriprocedural and through the immediate post-procedural period (up to 24 hours).",{"measure":14,"description":15,"timeFrame":12},"Feasibility of Bipolar external carotid artery circulation Stimulation","Feasibility will be demonstrated if stimulation can be successfully initiated and completed using the intended bipolar approach.",[17,21,25,29],{"measure":18,"description":19,"timeFrame":20},"Headache Severity Measured by the Visual Analog Scale (VAS)","Headache severity will be assessed using the Visual Analog Scale (VAS), a validated 0-10 cm scale in which participants indicate headache intensity by marking a point along a continuous line representing \"no pain\" to \"worst pain.\"","At baseline, Perioperative\u002FPeriprocedural, immediately post-procedure, and at following post-op times 2-4 hours, 7 days, 30 days, and 90 days.",{"measure":22,"description":23,"timeFrame":24},"Physiologic Responses During Stimulation","Physiologic responses, including heart rate, blood pressure, respiratory rate, and oxygen saturation, will be recorded during active stimulation to assess acute physiologic effects.","Perioperative\u002FPeriprocedural",{"measure":26,"description":27,"timeFrame":28},"Patient-Reported Qualitative Outcomes","Patient-reported qualitative outcomes includes perceived headache relief, tolerability of the intervention, and the presence of any new or worsening symptoms.","At 24 hours, 7 days, 30 days, and 90 days after the procedure.",{"measure":30,"description":31,"timeFrame":32},"Number of Adverse Events","Adverse events and serious adverse events including seizures, vascular complications, and signs of lidocaine toxicity.","Perioperative\u002FPeriprocedural, and at follow-up at 7 days, 30 days, and 90 days.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Single intervention arm","EXPERIMENTAL","Participants will undergo the planned external carotid artery circulation procedure. Before the lidocaine infusion begins, bipolar stimulation will be delivered through the external carotid artery circulation.\n\nDuring stimulation, clinicians will record vital signs, neurologic status, and headache severity using a 0-10 scale. Continuous intra-procedural monitoring will also be performed.\n\nAfter bipolar stimulation is completed, participants will receive lidocaine infusion as planned.",[46],"Device: Cadwell Cascade 32 PRO",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":33},"DEVICE","Cadwell Cascade 32 PRO","Cascade 32 PRO will be to gently deliver electrical pulses.",[42],[54],{"name":55,"affiliation":56,"role":57},"Peter Kan, MD,MPH","University of Texas Medial Branch","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":33,"email":63},"Matias Costa, MD","CONTACT","409-772-0330","mlcosta@utmb.edu",{"name":65,"role":61,"phone":62,"phoneExt":33,"email":66},"Patrick Karas, MD","pjkaras@utmb.edu",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University of Texas Medical Branch","RECRUITING","Galveston","Texas","77555-0133","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-94.7977,29.30135,{"lat":80,"lon":79},[83],{"name":60,"role":61,"phone":33,"phoneExt":33,"email":63},{"type":85,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100623924",false,"NCT07402954","Stimulation of External Carotid Artery Circulation","Feasibility and Safety of Endovascular Bipolar Stimulation of the Middle Meningeal Artery for Refractory Headaches (MMA-Stim)","MMA-Stim","Inclusion Criteria:\n\n* Age ≥18\n* Chronic migraine or status migrainosus, or craniofacial pain refractory to maximal medical therapy who are undergoing MMA IA lidocaine infusion.\n* Subject has provided informed consent.\n\nExclusion Criteria:\n\n* Known allergies to lidocaine\n* Seizure disorder, history of seizures, or increased seizure susceptibility\n* Intracranial vascular malformations or dural AVF\n* Hemodynamic instability, any condition where brief hemodynamic shifts may pose risk\n* Previous MMA intervention or craniotomy that could result in MMA occlusion\n* Any implanted electronic device (pacemaker, ICD, DBS, VNS, cochlear implant, spinal cord stimulator)\n* Significant cardiovascular disease (unstable angina, severe arrhythmias, recent MI)\n* Severe autonomic dysfunction\n* Active systemic infection\n* Vulnerable populations (i.e. pregnant individuals, children, prisoners, individuals lacking decision-making capacity, persons with cognitive impairment, those unable to provide informed consent)","ALL","18 Years","100 Years",{"count":97,"type":98},12,"ESTIMATED","INTERVENTIONAL",[35],"This study is testing a new approach to help people with migraine headaches. Researchers want to find out if using electrical stimulation to affect blood flow in the external carotid artery is safe and practical for helping control headaches.\n\nThe goal of the study is to determine whether this approach could improve headache symptoms and overall outcomes for people with migraines.",[103],"Migraine",[103,105,106],"External carotid artery circulation","Bipolar Stimulation","2026-02-18",{"date":109,"type":110},"2026-02-20","ACTUAL",{"date":112,"type":110},"2026-01-16",{"date":114,"type":98},"2027-08",{"name":5,"class":6},1]