[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647604":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":79,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":23,"enrollmentInfo":96,"targetDuration":23,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":113,"whyStopped":23,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Fribourg","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient VNS stimulation intervention","EXPERIMENTAL","FND patients received a 30 minutes VNS stimulation for 5 sessions during their usual physiotherapy course treatment.",[13],"Device: Vagial Nerve Stimulation (VNS) active stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Patient VNS sham intervention","SHAM_COMPARATOR","FND patients received a 30 minutes VNS sham for 5 sessions during their usual physiotherapy course treatment.",[19],"Device: Vagial Nerve Stimulation (VNS) sham stimulation",{"label":21,"type":22,"description":21,"interventionNames":23},"Heathy control without intervention","NO_INTERVENTION",null,[25,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Vagial Nerve Stimulation (VNS) active stimulation","taVNS sends gentle electric stimuli to the vagus nerve branch located in the outer ear, which are transmitted to the nucleus of the solitary tract in the brainstem, and from there to the rest of the brain. The electrode site is the cymba conchae in in the outer ear. VNS thus acts to enhance the activity of the parasympathetic nervous system.",[9],[31,32,33],"taVNS","tVNS","active",{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Vagial Nerve Stimulation (VNS) sham stimulation","taVNS sends gentle electric stimuli for several minutes, during which time the patient will feel a tickling sensation. Then, for the rest of the session, the hidden device will be switched off (there will be no stimulation).",[15],[31,32,39],"sham",[41],{"name":42,"affiliation":5,"role":43},"Cristina Concetti, PhD","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":23,"email":49},"Selma Aybek, Professor","CONTACT","+41 26 306 38 02","selma.aybek@unifr.ch",{"name":51,"role":47,"phone":52,"phoneExt":23,"email":53},"Michael Mouthon, PhD","+41 26 300 85 39","michael.mouthon@unifr.ch",[55],{"facility":5,"status":23,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Fribourg","Canton of Fribourg","1700","Switzerland","CH",{"type":62,"coordinates":63},"Point",[64,65],7.15128,46.80237,{"lat":65,"lon":64},[68,69,70,72,73,75,77],{"name":46,"role":47,"phone":48,"phoneExt":23,"email":49},{"name":51,"role":47,"phone":52,"phoneExt":23,"email":53},{"name":42,"role":71,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"name":51,"role":71,"phone":23,"phoneExt":23,"email":23},{"name":74,"role":71,"phone":23,"phoneExt":23,"email":23},"Julia Paratte, Master",{"name":76,"role":71,"phone":23,"phoneExt":23,"email":23},"Janne Magnin, Bachelor",{"name":78,"role":71,"phone":23,"phoneExt":23,"email":23},"Sarah Botman, Bachelor",{"type":80,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[82],{"name":83,"class":84},"Hôpital Cantonal de Fribourg","OTHER_GOV","100647604","investigating-the-neurophysiology-of-the-motor-system-and-the-feasibility-of-vagus-nerve-stimulation-in-functional-neurological-disorder-fnd-100647604",false,"NCT07710677","Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND)","Investigating the Neurophysiology of the Motor System and the Feasibility of Vagus Nerve Stimulation in Functional Neurological Disorder (FND): a Randomized, Sham-controlled Study","TMS-VNS","Inclusion Criteria for FND patients:\n\n* Over 18 years of age.\n* Capable of judgement.\n* Willing to participate in the study (by signing the informed consent form).\n* FND diagnosis by a certified neurologist or psychiatrist.\n* Motor FND symptoms in the upper limb in the form of tremor or weakness.\n* Participating in physiotherapy for FND.\n\nExclusion Criteria for FND patients:\n\n* Severe neuropsychiatric comorbidities.\n* Pregnancy or breastfeeding.\n* Prior knowledge on the effects of attention on the motor system.\n* Prior history of epilepsy or epileptic seizures in the person and their family.\n* Severe claustrophobia.\n* Implanted medical devices.\n* Ear anatomy incompatible with the taVNS device (e.g. cauliflower ear).\n* Previous use of taVNS.\n* Substance abuse.\n* Simultaneous participation in another investigation involving an investigational drug or a MD.\n* Enrolment of the PI and their dependent persons.\n\nInclusion Criteria for healthy volunteers:\n\n* Over 18 years of age.\n* Capable of judgement.\n* Willing to participate in the study (by signing the informed consent form).\n\nExclusion Criteria for healthy volunteers:\n\n* Neurological or neuropsychiatric or movement disorders.\n* Pregnancy or breastfeeding.\n* Prior knowledge on the effects of attention on the motor system.\n* Prior history of epilepsy or epileptic seizures in the person and their family.\n* Substance abuse.\n* Simultaneous participation in another investigation involving an investigational drug or a MD.\n* Enrolment of the PI and their dependent persons.",true,"ALL","18 Years",{"count":97,"type":98},68,"ESTIMATED","INTERVENTIONAL",[101],"NA","This clinical study will test if adding a non-invasive stimulation of the vagus nerve through the ear during physiotherapy brings an improvement to FND (Functional Neurological Disorder) patients with motor symptoms.\n\nFirst, the investigators will test the normal functioning of the motor regions of the brain in FND patients and in healthy volunteers for comparison, using a painless method called TMS (Transcranial Magnetic Stimulation). Then, the investigators will further test how brain regions communicate with each other in FND patients, using fMRI (functional Magnetic Resonance Imaging, also painless). Additionally, the investigators will ask both FND patients and healthy volunteers to answer questions about their health and wellbeing, and will assess the exact symptoms of FND patients. The FND patients will then be assigned to two groups randomly, and neither they nor the researchers will know in which group they are. Both groups will do 5 sessions of their usual physiotherapy - one group with a real stimulation of the vagus nerve, and the other group with a fake stimulation. This is important to obtain reliable results. At the end, both groups of patients will be tested again to see if the way brain regions communicate with each other has changed. They will also answer again questions about their health and wellbeing, and their symptoms will be assessed again, to see if any changes happen. The results of the two groups of patients will be compared to isolate the effects of vagus nerve stimulation from the effects of physiotherapy alone.",[104,105],"Functional Neurological Disorder","Motor Symptoms",[104,107,108,109,110,111,112],"FND","vagus nerve stimulation","VNS","TMS","fMRI","motor","NOT_YET_RECRUITING","2026-07-16",{"date":116,"type":117},"2026-07-17","ACTUAL",{"date":119,"type":98},"2026-07-01",{"date":121,"type":98},"2028-12-01",{"name":5,"class":6},1]