[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"posttraumatic-headache\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:posttraumatic-headache":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,75,102,124,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100486949","multisite-advancement-of-research-on-chronic-posttraumatic-headache-100486949",false,"NCT05620719","Multisite Advancement of Research on Chronic Posttraumatic Headache","Project MARCH: Multisite Advancement of Research on Chronic Posttraumatic Headache","Inclusion Criteria:\n\n* Any veteran or active duty service member (DEERS-eligible; age 18 to 70 years) with mild or moderate TBI whose headache began or exacerbated within 3 months of a head or neck injury.\n* Headache meets ICHD-3 A5.2 criterion for delayed-onset persistent headache attributable to mild or moderate TBI and PTH is ongoing at enrollment (most recent headache within the past 2 weeks).\n* At least moderate to severe headache-related disability based on a HIT-6 score greater than 50.\n* Participant is stable on headache medication at baseline assessment (i.e., no changes in medication prescriptions in the past 4 weeks or study physician clinical judgement confirms stability; this includes botulinum toxin injections and devices like Cefaly).\n* Participant has a phone where they can receive reminders and complete the on-line Headache Diaries.\n* Participant speaks and reads\u002Funderstands English well enough to fully participate in the intervention and to reliably complete assessment measures.\n\nExclusion Criteria:\n\n* Participant reports a significant change in headache symptoms within 4 weeks of screening or has another secondary headache that may account for symptoms.\n* Participant has medication overuse headache based on Structured Diagnostic Headache Interview-Revised (Brief Version; SDIH-R) and clinical judgment.\n* Participant has a psychiatric problem that warrants immediate treatment as indicated in the electronic health record, flagged study during testing, or confirmed by a clinician through screening or review of clinical notes.\n* Participant demonstrates significant cognitive impairment that could impact treatment adherence\u002Fbenefit.","ALL","18 Years","70 Years",{"count":20,"type":21},525,"ESTIMATED","INTERVENTIONAL",[24],"NA","Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 4 VA medical centers\\* and 3 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points.\n\n\\*VA Palo Alto Health Care System is temporarily randomizing into TAU and TCBT only.",[27],"Posttraumatic Headache",[29,30,31,32,33,34],"Cognitive Behavioral Therapy","Telehealth","Veterans","Military Service Members","Chronic Pain","Headaches","RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":39},"2023-08-24",{"date":43,"type":21},"2027-08",{"name":45,"class":46},"The University of Texas Health Science Center at San Antonio","OTHER",8,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100562831","phase-2-ketamine-sgb-and-combination-treatment-for-tbi-associated-headache-or-ptsd-100562831","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)",{"count":56,"type":21},175,[58],"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.",[27,61],"Posttraumatic Stress Disorder",[63,64],"Ketamine","Stellate Ganglion Block","2026-04-27",{"date":67,"type":39},"2026-05-01",{"date":69,"type":39},"2025-07-02",{"date":71,"type":21},"2028-04-30",{"name":73,"class":46},"Northwestern University",3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100597519","hypersensitivity-to-adrenomedullin-in-post-traumatic-headache-100597519","NCT07059546","Hypersensitivity to Adrenomedullin in Post-Traumatic Headache","Hypersensitivity to Adrenomedullin in Post- Traumatic Headache: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 18 to 65 years of age upon entry into screening\n* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)\n* ≥ 4 monthly headache days on average across the 3 months prior to screening\n* Provision of informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n* \\> 1 mild traumatic injury to the head\n* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)\n* History of moderate or severe injury to the head\n* History of whiplash injury\n* History of craniotomy\n* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion\n* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior\n* Female subjects of childbearing potential with a positive pregnancy test during any study visit\n* Cardiovascular disease of any kind, including cerebrovascular diseases\n* Hypertension (systolic blood pressure of ≥150 mmHg and\u002For diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day\n* Hypotension (systolic blood pressure of ≤90 mmHg and\u002For diastolic blood pressure of ≤50 mmHg)\n* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion\n* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start\n* Baseline headache intensity of \\>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)\n* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features","65 Years",{"count":84,"type":21},21,[24],"Adrenomedullin is a neuropeptide implicated in the pathogenesis of headache. This study investigates whether adrenomedullin induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).",[27],[89,90,91],"pain","adrenomedullin","posttraumatic headache","2025-07-28",{"date":94,"type":39},"2025-07-30",{"date":96,"type":21},"2025-08-01",{"date":98,"type":21},"2028-12-01",{"name":100,"class":46},"Danish Headache Center",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":101},"100580578","phase-3-safety-and-efficacy-of-botulinum-toxin-a-in-patients-with-posttraumatic-headache-100580578","NCT06839118","Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache","Safety and Efficacy of Botulinum Toxin A in Patients With Posttraumatic Headache: a Double-blind, Randomized, Placebo-controlled, Parallel-group Trial and Investigation of Neuroinflammatory Biomarkers as Predictors of Efficacy","Inclusion Criteria:\n\n1. A diagnosis of persistent PTH according to criteria 5.2.2 Persistent headache attributed to mild traumatic injury to the head according to The International Classification of Headache Disorders 3rd edition.\n2. Age between 18 and 80 years.\n3. Subjects must have headache at least 15 days per month during the last 4 weeks to enter the baseline phase.\n4. During baseline phase subjects must experience moderate-to-severe headache at least 8 days and headache at least 15 days to enter the treatment phase (to be randomized).\n5. Fluency in Danish\n\nExclusion Criteria:\n\n1. More than 2 TBI's.\n2. Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.\n3. Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject's and investigator's knowledge.\n4. Ongoing and unstable severe psychiatric disease.\n5. Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.\n6. A history of migraine or tension-type headache more than 5 days per month before the TBI.\n7. Medication-overuse headache according to the according to The International Classification of Headache Disorders 3rd edition.\n8. A history of moderate-to-severe TBI, whiplash injury, or craniotomy.\n9. Change of preventive PTH treatment or treatment dose within two months prior to the baseline visit (see Section 6.4 for a full list of these medications).\n10. Previous treatment with injections of BTX-A in the head or face.\n11. Female subjects either pregnant, breastfeeding or with planned conception within the study period.\n12. Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study. Acceptable methods of effective birth control include not having intercourse (true abstinence, when this is in line with the preferred and usual lifestyle of the subject), hormonal birth control methods (pills, shots\u002Finjections, implants, or patches), intrauterine devices, surgical contraceptive methods (vasectomy with medical assessment of the surgical success of this procedure or bilateral tubal ligation). Female subjects not of childbearing potential are defined as any female who: is post-menopausal by history, defined as:\n\n    1. Age ≥ 55 years with cessation of menses for 12 or more months, OR\n    2. Age \\\u003C 55 years but no spontaneous menses for at least 2 years, OR\n    3. Age \\\u003C 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (e.g., spontaneous, or secondary to hysterectomy), AND with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels \\> 40 IU\u002FL) or postmenopausal estradiol levels (\\\u003C 5 ng\u002FdL) or according to the definition of \"postmenopausal range\" for the laboratory involved OR underwent bilateral oophorectomy OR underwent hysterectomy OR underwent bilateral salpingectomy.\n13. Known allergy to any component of BTX-A.\n14. Infection at the proposed injection site.\n15. Known severe neuromuscular disorders or any degree of disorder affecting the neuromuscular transmission.\n16. Known comprised respiratory function.\n17. Member of investigational site staff or relative of the investigator.","80 Years",{"count":111,"type":21},80,[113],"PHASE3","The study is an investigator-initiated randomized, placebo-controlled, double-blind, parallelgroup trial. Eighty subjects with PTH will be included and randomized 1:1 for treatment with BTX-A or placebo (isotonic saline). The study comprises a 4-week baseline phase before injection of either active drug or placebo followed by a 12-week evaluation period. Treatment will be double-blind, and subjects will only receive one treatment cycle. Endpoints will be assessed in the evaluation period (weeks 5 to 8) compared to baseline (weeks -4 to -1).",[27],"2025-02-16",{"date":118,"type":39},"2025-02-21",{"date":120,"type":39},"2025-01-10",{"date":122,"type":21},"2026-08-01",{"name":100,"class":46},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100551931","non-pharmacological-treatment-of-patients-at-risk-of-developing-persistent-posttraumatic-headache-100551931","NCT06466499","Non-pharmacological Treatment of Patients at Risk of Developing Persistent Posttraumatic Headache","Inclusion criteria:\n\n* Clinical diagnosed with acute posttraumatic headache\n* Headache present for more than 15 days\u002Fmonth\n* Must understand written and spoken Danish\n\nExclusion criteria:\n\n* History of pre-existing primary or secondary headache\n* Dementia or comorbidity with neurological disorders\n* Psychiatric disorders\n* Participants who cannot collaborate in relation to the intervention","60 Years",{"count":132,"type":21},104,[24],"The goal of this mixed method study is to test and evaluate the effect of an early interdisciplinary non-pharmacological treatment of patients at risk of developing persistent posttraumatic headache in order to prevent the development of persistent posttraumatic headache and thereby, reduce persistency and improve the quality of life. Furthermore, to gain knowledge on and a deeper understanding of the patients' perspective and experience of the treatment.\n\nThe project consists of 3 sub studies:\n\n1. A feasibility study; with the purpose of exploring the feasibility of an early non-pharmacological intervention for patients with persistent posttraumatic headache after mild traumatic brain injury.\n2. An experimental design; a randomized controlled trial to evaluate the effect of the early non-pharmacological treatment.\n3. A qualitative focus group interview study; to get a more nuanced knowledge of patients' experience with the non-pharmacological treatment related to post traumatic headache.",[27],"NOT_YET_RECRUITING","2024-11-27",{"date":139,"type":39},"2024-12-02",{"date":141,"type":21},"2024-12-01",{"date":143,"type":21},"2027-05-05",{"name":145,"class":46},"Esbjerg Hospital - University Hospital of Southern Denmark",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":169},"100443028","phase-2-treatment-of-acute-pth-with-a-cgrp-receptor-mab-in-military-service-members-and-civilians-with-mtbi-100443028","NCT05049057","Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI","Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension","Inclusion Criteria:\n\n* Male or female ≥18 and ≤50 years of age\n* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days\n* PTH has occurred within the prior 7 days\n* Able to provide informed consent\n* Likely to stay in the same geographical area for the duration of study\n* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider\n\nExclusion Criteria:\n\n* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:\n\n  1. abnormal structural imaging\n  2. loss of consciousness for \\>30 minutes\n  3. alteration of consciousness\u002Fmental state for \\>24 hours 3. post-traumatic amnesia for \\>1 day\n* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury","50 Years",{"count":155,"type":21},404,[58],"This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).",[27,159],"Mild Traumatic Brain Injury","2024-02-21",{"date":162,"type":39},"2024-02-22",{"date":164,"type":39},"2022-07-19",{"date":166,"type":21},"2027-05-19",{"name":168,"class":46},"Henry M. Jackson Foundation for the Advancement of Military Medicine",4]