[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516794":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":45,"studyPopulation":34,"armGroups":46,"interventions":57,"overallOfficials":34,"centralContacts":63,"locations":73,"responsibleParty":93,"collaborators":34,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":34,"eligibilityCriteria":101,"healthyVolunteers":98,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":34,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":75,"whyStopped":34,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"A modified McGill Pain Questionnaire","Pain intensity, 0-10 score, with 0 means no pain and 10 means worst pain","at 0,4, weeks of the study,",[14,18,21,24,28,31],{"measure":15,"description":16,"timeFrame":17},"Multidimensional Fatigue Inventory","Fatigue level, 1-5 score, base on the statement, answer 1 means completely true and answer 5 means no, that is not true.","at 0,4,8 weeks of the study",{"measure":19,"description":20,"timeFrame":17},"Medical Outcomes Study Sleep Scale","sleep quality, score 1-6, base on the statement, answer 1 means all of the time, answer 6 means none of the time",{"measure":22,"description":23,"timeFrame":17},"Revised Fibromyalgia Impact Questionnaire","Fibromyalgia impact, 0-10, answer 0 means no impact, 10 means the most impact",{"measure":25,"description":26,"timeFrame":27},"Medical Outcomes Study Questionnaire Short Form 36","Quality of life measure, answer in descriptive degree of impact to life from: not at all, slightly, moderately, severe, very severe.","at 0, 4, 8 weeks of the study",{"measure":29,"description":30,"timeFrame":27},"Blood inflammation marker","collect blood sample for cytokines level",{"measure":32,"description":33,"timeFrame":27},"Assessment of gut microbiome changes through genomic phenotypic","collect stool sample to analyze bacterial composition and metabolomic profiles of gut microbiome",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","4-week of clinical study with a total of 60 subjects, randomized into 2 groups (30 subjects in tVNS and 30 subjects in control group )","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":42},"DOUBLE",[43,44],"PARTICIPANT","INVESTIGATOR","The main goal of this study is to generate preliminary data on the effect of VNS on FM symptoms. Specifically, the investigators will utilize a recently developed, non-invasive method of tVNS (transcutaneous VNS) via auricular branches of vagus nerve (ABVN). The investigators plan to conduct an 4-week clinical study with 60 subjects randomized into 2 groups(tVNS group and control group; 30 subjects in each group). The primary outcome measure will be pain intensity. The secondary outcome measures will be fatigue, sleep, and other health-related quality of life measure. These outcome measures will be made at baseline week 0 (before any intervention), and at the end of 4 weeks.",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Transcutaneous Vagus Nerve Stimulation(tVNS)","EXPERIMENTAL","receive tVNS 30 minutes per session, twice\u002Fday for 4 weeks and maintain regular medication treatment without change.",[52],"Device: Transcutaneous Vagus Nerve Stimulation",{"label":54,"type":55,"description":56,"interventionNames":34},"Sham Control group","NO_INTERVENTION","receive sham point stimulation 30 minutes per session, twice\u002Fday for 4 weeks and maintain regular medication treatment without change.",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":34},"DEVICE","Transcutaneous Vagus Nerve Stimulation","30 minutes stimulation, twice per day for 4 weeks",[48],[64,69],{"name":65,"role":66,"phone":67,"phoneExt":34,"email":68},"Lucy Chen, M.D.","CONTACT","617-724-3466","llchen@mgh.harvard.edu",{"name":70,"role":66,"phone":71,"phoneExt":34,"email":72},"Jianren Mao, M.D.","617-726-2338","jmao@mgh.harvard.edu",[74],{"facility":5,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":82,"coordinates":83},"Point",[84,85],-71.05977,42.35843,{"lat":85,"lon":84},[88,90,91],{"name":65,"role":66,"phone":89,"phoneExt":34,"email":68},"617-724-6102",{"name":70,"role":66,"phone":89,"phoneExt":34,"email":72},{"name":65,"role":92,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":92,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Lucy Chen","Associate Professor","100516794","vagus-nerve-stimulationvns-as-treatment-for-fibromyalgia-patients-100516794",false,"NCT06009159","Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients","Inclusion Criteria:\n\n1. Subject is 18 to 80 years old, including both male and female subjects.\n2. Subject has a documented diagnosis of FM for at least three months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.\n3. Subject has a pain score of 4 or above (numeric pain score: 0 - 10 from no pain to worst pain).\n\nExclusion Criteria:\n\n1. Subject has current cardiac arrhythmia or had implanted cardiac pacemaker or AICD device.\n2. Subject has major psychiatric disorder required hospitalization in the last 3 months.\n3. Subject has active infection at the site of device application.\n4. Subject has recurrent syncope symptoms within the past three months.\n5. Subject is pregnant.\n6. Subject has had VNS treatment within the past two months.\n\n   .","ALL","18 Years","80 Years",{"count":106,"type":107},60,"ESTIMATED","INTERVENTIONAL",[110],"NA","Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.",[113],"Fibromyalgia",[115,116,117],"Vagus nerve stimulation,","pain","fibromyalgia symptoms","2026-09-10",{"date":120,"type":121},"2026-09-14","ACTUAL",{"date":123,"type":121},"2024-07-01",{"date":125,"type":107},"2029-10-31",{"name":5,"class":6},1]