[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561061":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":32,"locations":40,"responsibleParty":57,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":24,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"#1: Patient controlled","EXPERIMENTAL","Patient will ramp up current intensity until uncomfortable, then ratchet back to what is comfortable and press button. Patient is to do this daily for 35 minutes for 6 weeks.",[13],"Device: Transcutaneous vagus nerve stimulator",{"label":15,"type":10,"description":16,"interventionNames":17},"#2: Device Controlled","Patients will ramp up current intensity until uncomfortable, then ratchet back to what is comfortable and press button. The device has software embedded in it that is used to arrive at a personalized way of stimulating the vagus nerve. At this level, the device stimulus will not be sensed by the patient. Patient is to do this daily for 35 minutes for 6 weeks.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Transcutaneous vagus nerve stimulator","A device attached to the tragus of the ear which when activated stimulates an ascending branch of the vagus nerve",[9,15],null,[26,29],{"name":27,"affiliation":5,"role":28},"Benjamin H Natelson, MD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":31},"Anna Norweg, PhD","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":24,"email":37},"Patrick Quan","CONTACT","212-844-6665","Patrick.quan@mssm.edu",{"name":30,"role":35,"phone":36,"phoneExt":24,"email":39},"anna.norweg@mssm.edu",[41],{"facility":5,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","New York","10029","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-74.00597,40.71427,{"lat":51,"lon":50},[54,56],{"name":27,"role":35,"phone":36,"phoneExt":24,"email":55},"benjamin.natelson@mountsinai.org",{"name":30,"role":35,"phone":36,"phoneExt":24,"email":39},{"type":28,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Benjamin Natelson","Professor of Neurology","100561061","tvns-in-long-covid-19-100561061",false,"NCT06585254","tVNS in Long COVID-19","Use of Transcutaneous Vagus Nerve Stimulation in Reducing the Symptoms of Long COVID Patients Who Fulfill Diagnostic Criteria for ME\u002FCFS","Inclusion Criteria:\n\n* Must have had documented Covid infection and then fulfill 2015 case definition for ME\u002FCFS\n* Chalder Fatigue Scale score of 4 or greater\n* SF-36 Physical Function scale score ≤70\n* VAS values of 3 or higher from 0 \\[none\\] 3 \\[substantial\\] to 5 \\[very severe burden\\] on at least two of the following symptoms - fatigue; widespread pain, brain fog, post-exertional malaise\n\nExclusion Criteria:\n\n* BMI ≥30\n* Hospitalized for COVID-19 infection\n* BMI ≥30\n* Pregnancy","ALL","21 Years","70 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","A prior open label study has shown that transcutaneous vagus nerve stimulation \\[tVNS\\] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill criteria for myalgic encephalomyelitis \u002F chronic fatigue syndrome (ME\u002FCFS). The purpose of this study is to compare two sets of stimulus parameters to determine the one that best improves the health-related quality of life of these patients over a period of 6-weeks. Patients using their assigned device for at least 30 of the 42 possible opportunities will receive the best device for an additional 6-week period.",[78,79],"Long COVID","Chronic Fatigue Syndrome",[81,82],"Medically unexplained illness","Vagus Nerve","2025-08-04",{"date":85,"type":86},"2025-08-08","ACTUAL",{"date":88,"type":86},"2024-11-01",{"date":90,"type":72},"2026-12-31",{"name":5,"class":6},1]