[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646710":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":30,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":38,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Texas Christian University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"tAN treatment","EXPERIMENTAL","For perimenopausal women: tAN administration 2 hours daily. For PMS\u002FPMDD women: tAN administration 2 hours daily during the luteal phase.",[13],"Device: transcutaneous auricular neurostimulation (tAN)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","transcutaneous auricular neurostimulation (tAN)","Device: Sparrow Link. The Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and\u002For around the auricle.\n\nThis device will stimulate the auriculotemporal nerve (ATN) and the auricular branch of the vagus nerve (ABVN)",[9],[21],"Sparrow Link",[23],{"name":24,"affiliation":5,"role":25},"Sarah E Hill, PhD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","817-257-6424",null,"s.e.hill@tcu.edu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Savannah A Hastings, M.S.","817-257-4989","s.a.hastings@tcu.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Fort Worth","Texas","76109","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-97.32085,32.72541,{"lat":48,"lon":47},[51,52,54],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":53,"phoneExt":30,"email":35},"8172574989",{"name":24,"role":25,"phone":30,"phoneExt":30,"email":30},{"type":25,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Sarah Hill","Professor",[59],{"name":60,"class":61},"Spark Biomedical, Inc.","INDUSTRY","100646710","transcutaneous-auricular-neurostimulation-tan-for-premenstrual-dysphoric-disorder-pmdd-and-perimenopause-100646710",false,"NCT07688720","Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause","PMS\u002FPMDD Study:\n\nInclusion Criteria:\n\n* Assigned female at birth\n* Age 18 to 45\n* Naturally cycling\n* Regularly occurring menstrual cycle\n* Must identify as having PMS or PMDD\n* Reliable ability to complete online study surveys\n\nExclusion Criteria:\n\n* Using hormonal birth control\n* Pregnant or lactating\u002Fbreastfeeding\n* History of seizures\n* Implanted devices\n* Current or previous diagnosis of any heart conditions\n* Abnormal ear anatomy\n* Non-removable piercings on the ear\n* Recent ear infection\n* Taking SSRIs\n* Taking steroids\n* Taking hormone therapy\n* If the participant anticipates starting or stopping prescription medications during the study period\n* Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)\n* Participant has a history traumatic brain injury within the past 12 months\n* Must not have any other mental illness or mood disorder\n\nPerimenopause Study:\n\nInclusion Criteria:\n\n* Assigned female at birth.\n* Age 40 to 55\n* Must have newly variable menstrual cycles or report identifying as perimenopausal\n* Reliable ability to complete online study surveys\n\nExclusion Criteria:\n\n* Using hormonal birth control\n* Pregnant or lactating\u002Fbreastfeeding\n* History of seizures\n* Implanted devices\n* Current or previous diagnosis of any heart conditions\n* Abnormal ear anatomy\n* Non-removable piercings on the ear\n* Recent ear infection\n* Taking SSRIs\n* Taking steroids\n* Taking hormone therapy\n* If the participant anticipates starting or stopping prescription medications during the study period.\n* Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)\n* Participant has a history traumatic brain injury within the past 12 months\n* have a hysterectomy\n\nIn both studies we will confirm that participants are symptomatic shortly following enrollment.","FEMALE","18 Years","55 Years",{"count":72,"type":73},20,"ESTIMATED","INTERVENTIONAL",[76],"NA","Transcutaneous Auricular Neurostimulation (tAN) will be administered to women with premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), and perimenopause. The investigators will examine whether tAN improves symptomology by collecting self-report data before the intervention, during the intervention, and following the intervention.",[79,80],"Perimenopause","PMDD",[82,83,84,79,85],"Premenstrual Symptoms","Menopause","Women's health","Premenstrual Dysphoric Disorder","2026-06-30",{"date":88,"type":89},"2026-07-07","ACTUAL",{"date":91,"type":73},"2026-06",{"date":93,"type":73},"2027-03",{"name":5,"class":6},1]