[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452813":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":55,"locations":62,"responsibleParty":80,"collaborators":36,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":36,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":36,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":65,"whyStopped":36,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Veterans Medical Research Foundation","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Active rTMS with telehealth headache management therapy","ACTIVE_COMPARATOR","Participants receive both active rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management",[13,14],"Device: Active rTMS","Behavioral: Headache Management Therapy",{"label":16,"type":6,"description":17,"interventionNames":18},"Active rTMS with telehealth headache education control","Participants receive active rTMS treatment at the left dorsolateral prefrontal cortex and headache education",[13,19],"Behavioral: Headache Education Control",{"label":21,"type":6,"description":22,"interventionNames":23},"Sham rTMS with telehealth headache management therapy","Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and therapy for headache management",[14,24],"Device: Sham rTMS",{"label":26,"type":27,"description":28,"interventionNames":29},"Sham rTMS with telehealth headache education control","SHAM_COMPARATOR","Participants receive sham rTMS treatment at the left dorsolateral prefrontal cortex and headache education",[24,19],[31,37,42,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Active rTMS","Active rTMS will be given at the left dorsolateral prefrontal cortex with a double blind TMS coil.",[16,9],null,{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":36},"BEHAVIORAL","Headache Management Therapy","Therapy will be provided on headache management.",[9,21],{"type":32,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"Sham rTMS","Sham rTMS will be given at the left dorsolateral prefrontal cortex. All parameters of the treatment will appear identical to the active treatment, with only the rTMS coil used to administer the treatment flipped 180 degrees to prevent stimulation.",[26,21],{"type":38,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"Headache Education Control","In the control, educational sessions on headaches will be provided.",[16,26],[51],{"name":52,"affiliation":53,"role":54},"Albert Y Leung, MD","San Diego Veterans Healthcare System","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Caleb Lopez, BS","CONTACT","858-552-8585","2638","caleb.lopez@va.gov",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"VA San Diego Healthcare System","RECRUITING","San Diego","California","92161","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-117.16472,32.71571,{"lat":75,"lon":74},[78,79],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},{"name":52,"role":58,"phone":36,"phoneExt":36,"email":36},{"type":81,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100452813","combined-transcranial-magnetic-stimulation-and-therapy-for-mtbi-related-headaches-100452813",false,"NCT05176392","Combined Transcranial Magnetic Stimulation and Therapy for MTBI Related Headaches","Combined Nonpharmacological Therapies for MTBI-Related Headaches","Inclusion Criteria:\n\n1. Mild Traumatic Brain Injury (mTBI)\n2. Chronic headaches \\> 3 months after injury\n3. Aged 18-65\n4. No prior TMS treatment\n5. Persistent Headaches with an intensity \\> 30 \u002F 100\n6. No history of daily headache prior to mTBI\n\nExclusion Criteria:\n\n1. Pregnant\n2. Pacemaker or any metal in body that would prevent MRI\n3. History of dementia or major psychiatric disease, such as bipolar disorder or schizophrenia\n4. Presence of any other chronic neuropathic pain states\n5. History of seizure\n6. Pending litigation\n7. Can't understand English\n8. History of chronic headache like migraine prior to mTBI\n9. Evidence in chart of exacerbation of depressive\u002Fanxiety symptoms, active substance dependence, suicidal intent or attempt within previous month","ALL","18 Years","65 Years",{"count":93,"type":94},240,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study will assess the combined effectiveness of repetitive transcranial magnetic stimulation (rTMS) and telehealth based therapy in helping manage mild traumatic brain injury (mTBI) related headaches. The investigators hypothesize that active rTMS combined with telehealth therapy will provide marked reduction in mTBI related headaches and symptoms in comparison to their placebo counterparts.",[100,101,102],"TBI (Traumatic Brain Injury)","Headache","Depression",[104,105,106],"rTMS","transcranial magnetic stimulation","therapy","2024-11-18",{"date":109,"type":110},"2024-11-21","ACTUAL",{"date":112,"type":110},"2022-01-01",{"date":114,"type":94},"2025-08-31",{"name":5,"class":6},1]