[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384490":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":39,"locations":44,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: active stimulation then placebo stimulation","EXPERIMENTAL","VNS active stimulation: Use of device (Tens Eco Plus SCHWA MEDICO™) for 8 weeks, then VNS placebo for 8 weeks.\n\nThe two stimulation periods will be separated by a 4 +\u002F- 1 weeks wash-out period.\n\nThe VNS placebo stimulation period being the control one.",[13],"Device: active stimulation then placebo stimulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: placebo stimulation then active stimulation","VNS placebo for 8 weeks, then VNS active stimulation Use of device (Tens Eco Plus SCHWA MEDICO™) for 8 weeks.\n\nThe two stimulation periods will be separated by a 4 +\u002F- 1 weeks wash-out period.\n\nThe VNS placebo stimulation period being the control one.",[18],"Device: placebo stimulation then active stimulation",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","active stimulation then placebo stimulation","The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient.\n\nA transcutaneous vagus nerve stimulator Tens Eco Plus SCHWA MEDICO™ France with the Garches Azabou-Bao vagal electrode (the G electrode) will be used in this Clinical Investigation.\n\nVNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015).\n\nThe two stimulation periods will be separated by a 4 weeks wash-out period.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"placebo stimulation then active stimulation","VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015).\n\nThe active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient.\n\nA transcutaneous vagus nerve stimulator Tens Eco Plus SCHWA MEDICO™ France with the Garches Azabou-Bao vagal electrode (the G electrode) will be used in this Clinical Investigation.\n\nThe two stimulation periods will be separated by a 4 weeks wash-out period.",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Eric AZABOU, MD, PhD","Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":38},"Maxime Breban, MD, PhD","Department of Rheumatology, Ambroise Paré Hospital, APHP","STUDY_DIRECTOR",[40],{"name":32,"role":41,"phone":42,"phoneExt":25,"email":43},"CONTACT","+ 33 1 47 10 79 40","eric.azabou@aphp.fr",[45],{"facility":33,"status":25,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":25},"Garches","Hauts-de-seine","92380","France","FR",{"type":52,"coordinates":53},"Point",[54,55],2.18232,48.84226,{"lat":55,"lon":54},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100384490","efficacy-of-non-invasive-vagus-nerve-stimulation-for-axial-spondyloarthritis-resistant-to-biotherapies-100384490",false,"NCT04286373","Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies","Randomized Cross Over Study Assessing the Effectiveness of Non-invasive Vagus Nerve Stimulation in Patients With Axial Spondyloarthritis Resistant to Biotherapies","ESNV-SPA","Inclusion Criteria:\n\n* Patient from 18 to 90 years with axial SpA, meeting the ASAS classification criteria, followed for at least one year, with presence of radiological sacro-illitis (ankylosing spondylitis) or not;\n* Patient suffering active SpA, with or without treatment, having a total BASDAI score ≥ 4 (0-10) at baseline and a score of global pain ≥ 4 (0-10);\n* SpA insufficiently relieved despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 3 months (or less in case of intolerance) and at least two lines of biotherapies or discontinued SpA treatments due to intolerance, contraindication.\n\nExclusion Criteria:\n\n* Patient under guardianship;\n* Cardiac arrhythmia;\n* Patients with cochlear implant;\n* Patients with known heart disease;\n* Hypotension;\n* Asthmatic patients;\n* Refusal to participate in the study or to sign the informed consent;\n* Pregnant or breastfeed woman;\n* No affiliation to a social security scheme;\n* Previous VNS treatment;\n* Incapacity to attend the weekly appointment during the study period;\n* 12- Head trauma with fracture of rock. In case of skin lesions of the left ear, recruitment will be delayed until these lesions are healed.","ALL","18 Years","90 Years",{"count":71,"type":72},120,"ESTIMATED","INTERVENTIONAL",[75],"NA","The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group).\n\nThe secondary objectives of the Clinical Investigation are to show differences in disease evolution between the active and placebo periods of 8 weeks treatment with active VNS versus placebo VNS of the following items:\n\n1. Change in disease activity according to \"ASAS40\" criteria\n2. Obtaining a partial remission according to the ASAS definition\n3. Change in BASFI\n4. Change in C-reactive protein (CRP)serum level and erythrocytes sedimentation rate (ESR),\n5. Change in ASDAS\\_CRP and ASDAS\\_ESR\n6. Difference in levels of circulating cytokines, IL-6, IL-23, IL-17, IL-33 and of matrix metallopeptidases (MMP3-8-9).\n7. Change in quality of life : assessment according to the following indexes: SF-36, AS Quality of Life (ASQOL)\n8. Change in Health Index of patient with SpA (ASAS HI) and of the Productivity at Work Index (WPI)\n9. Change in fatigue (BASDAI 1st question) and global pain\n10. Change in Anxiety and Depression Assessment (HAD)\n11. Change in BASMI\n12. Change in non-steroidal anti-inflammatory drugs (NSAID) intake score.",[78],"Axial Spondyloarthritis",[80,81],"axial spondyloarthritis","vagus nerve stimulation","NOT_YET_RECRUITING","2025-04-25",{"date":85,"type":86},"2025-04-27","ACTUAL",{"date":88,"type":72},"2025-09",{"date":90,"type":72},"2026-12",{"name":5,"class":6},1]