[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648255":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":39,"locations":50,"responsibleParty":69,"collaborators":52,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":52,"enrollmentInfo":81,"targetDuration":52,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":98,"whyStopped":52,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS plus PEPC","EXPERIMENTAL","Transauricular vagus nerve stimulation (taVNS) provided for 2 hours per day for weeks. Frequency: 25 Hz on inner region (ABVN), 100Hz on outer region (ATN), Pulse width: 250 µs, Duty cycle: 5 minutes on, 10 second off. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.",[13],"Device: taVNS plus PEPC",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham plus PEPC","SHAM_COMPARATOR","Sham will use the same device and schedule with a brief individualized suprasensory stimulation followed by a ramp down over 2 minutes. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.",[19],"Device: sham plus PEPC",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The research version of Spark's Sparrow Ascent for vagus nerve stimulation provided through a sticker that attaches to the ear. This device allows the patient to self apply the device in a home setting. It is FDA cleared and available in VA. Stimulation is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.",[9],[26],"Sparrow Link",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"sham plus PEPC","Same device as active condition but programmed with sham parameters including suprasensory stimulation followed by ramp down. Sham is combined with 6, 30 minute sessions on Processing Emotions in Primary Care (PEP) brief PTSD psychotherapy provided over 4 weeks.",[15],[26],[33,37],{"name":34,"affiliation":35,"role":36},"Sheila A.M. Rauch, PhD","Atlanta VA Medical and Rehab Center, Decatur, GA","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Anna Woodbury, MD",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Sheila A Rauch, PhD","CONTACT","(404) 621-3122","3122","Sheila.Rauch@va.gov",{"name":38,"role":42,"phone":47,"phoneExt":48,"email":49},"(404) 321-6111","6939","Anna.Woodbury@va.gov",[51],{"facility":35,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},null,"Decatur","Georgia","30033-4004","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-84.29631,33.77483,{"lat":62,"lon":61},[65,66,67,68],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},{"name":38,"role":42,"phone":47,"phoneExt":48,"email":49},{"name":38,"role":36,"phone":52,"phoneExt":52,"email":52},{"name":34,"role":36,"phone":52,"phoneExt":52,"email":52},{"type":70,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100648255","treatment-of-fibromyalgia-and-ptsd-with-live-and-inactive-vagus-nerve-stimulation-with-pepc-100648255",false,"NCT07718984","Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC","SWIFT-RELIEVE : Simultaneous Treatment of Widespread Pain In Fibromyalgia and PTSD: Randomized Evaluation of Live vs. Inactive Electrical VNS With PE-PC","SWIFT-RELIEVE","Inclusion Criteria:\n\n1. Subjects must be any era Veterans reporting FM and PTSD symptoms (PTSD Checklist for DSM-5 (PCL-5) ≥ 28; FM confirmed with ACR Diagnostic Criteria and pain score at least 4\u002F10 for 3 months \\[94\\]\n2. Subjects must speak English\n3. If subjects are taking psychotropic medication, 2-weeks on stable dose prior to enrollment and agreement to maintain current medications until after the \\[4-month follow-up visit\\]\n\nExclusion Criteria:\n\n1. Subjects must not have other primary clinical issues that would interfere with FM or PTSD treatment such as recent stroke or severe heart disease\n2. Subjects must not have a level of suicide risk that requires intervention as determined by item 9 on PHQ-9 with follow-up risk assessment by study staff\n3. Subjects must not have severe cognitive impairment that interferes with PE-PC (unable to retain information in acute interaction)\n4. Subjects must not have unmanaged psychosis or bipolar disorder\n5. Subjects must not have moderate to severe substance use disorder in the past 8 weeks\n6. Subjects must not be currently receiving talk therapy for trauma-related symptoms or FM\n7. Subjects must not be currently pregnant or lactating given risk of pre-term labor and interference of oxytocin with VNS effects","ALL","18 Years",{"count":82,"type":83},180,"ESTIMATED","INTERVENTIONAL",[86],"NA","Fibromyalgia (FM) pain and PTSD are highly prevalent and comorbid with associated increased risk of negative physical and mental health outcomes, including higher risk for opioid use and suicide. This project is designed to determine the effects of a 4 week trial of a device for pain management \\[transauricular vagus nerve stimulation (taVNS)\\] on pain interference and intensity \\[Pain, Enjoyment, and Activity General Scale (PEG)\\] and PTSD. The investigators will also examine how this impacts the Veterans by examining heart rate variability (HRV) as a stress response related biomarker. The investigators plan to randomize 180 Veterans (estimate up to 360 enrolled) with co-morbid FM and PTSD across pain integrated care and PTSD sites in this prospective study and compare: 1) active taVNS for pain + Prolonged Exposure in Primary Care (PE-PC) and 2) sham taVNS + PE-PC. Study includes 4 weeks of randomized treatment and 4 weeks of voluntary open label treatment. Veterans are assessed (self report \\& interview measures, heart rate variability by wearable device) at Intake, Baseline\u002FPost Run-In, Week 2, Week 4, Week 8 and 4 month follow-up. The investigators plan to retain data after the study for potential future use in research.",[89,90],"Fibromyalgia (FM)","Posttraumatic Stress Disorder (PTSD)",[92,93,94,95,96,97],"fibromyalgia","post-traumatic stress disorder","pain","heart rate variability","vagus nerve stimulation","treatment","NOT_YET_RECRUITING","2026-07-23",{"date":101,"type":102},"2026-07-27","ACTUAL",{"date":104,"type":83},"2027-01-01",{"date":106,"type":83},"2030-12-31",{"name":5,"class":6},1]