[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548578":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group (HRV-BFB training)","EXPERIMENTAL","Participants assigned to the experimental group will undergo HRV Biofeedback training using the Inner Balance Coherence Plus® software. This software incorporates a Bluetooth plethysmograph ear sensor, which will transmit cardiac pulse data to the Inner Balance Coherence Plus smartphone app, where the EmWave Pro® Plus software will extract HRV in real-time. This software will display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). Fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the HRV-BFB intervention, participants will be instructed to maximize their HRV.",[13],"Other: Heart rate variability Biofeedback [HRV-BFB]",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Control group (Pseudo HRV-BFB training)","PLACEBO_COMPARATOR","Participants assigned to the placebo group will undergo a pseudo HRV Biofeedback training using the same Inner Balance Coherence Plus® software and ear sensor. The software will similarly display the participant's HRV-BFB curve on their smartphone. The installation of the program and necessary instructions for its use will be provided at the first visit (V1). To manage placebo effects, the same fractional training sessions of 8 minutes will be recommended, twice daily for 30 days (during the period V1-V2 or the period V2-V3). Respiratory instructions will differ between the two interventions. During the placebo pseudo BFB training, participants will be instructed to no have specific effect on HRV.",[19],"Other: Pseudo HRV-BFB",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Heart rate variability Biofeedback [HRV-BFB]","Biofeedback (BFB), sometimes referred to as \"biological feedback technique,\" is a non-invasive and non-pharmacological approach based on physiological recordings that provide real-time feedback enabling people to learn how to control their physiological processes, which are typically unconscious and beyond their control. HRV-BFB specifically targets heart rate variability (HRV), which can help regulate the autonomic nervous system (including vagal tone and sympathetic-parasympathetic balance) as well as emotional states. HRV-BFB has been clinically and experimentally validated as a physiological intervention and has demonstrated its effectiveness. However, it has never been studied in an adult FND population.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Pseudo HRV-BFB","The pseudo HRV-BFB intervention aims to implement the same HRV BFB methods with no specific effect on HRV.",[15],[31],{"name":32,"affiliation":33,"role":34},"Dang Khoa Nguyen","Université de Montréal's affiliated hospital research centre","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Jasmine Carlier, PhD student","CONTACT","514-890-8000","28404","jasmine.carlier.chum@ssss.gouv.qc.ca",{"name":43,"role":38,"phone":39,"phoneExt":40,"email":44},"Dang Khoa Nguyen, Pr","d.nguyen@umontreal.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Université de Montréal's affiliated Hospital Research Centre (CRCHUM)","RECRUITING","Montreal","Quebec","H2X 0C1","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-73.58781,45.50884,{"lat":58,"lon":57},[61,65,67,68],{"name":62,"role":38,"phone":63,"phoneExt":25,"email":64},"Jasmine Carlier, MD","(+33)680891913","jasmine.rachel.zoe.carlier@umontreal.ca",{"name":66,"role":38,"phone":51,"phoneExt":40,"email":44},"Dang Khoa Nguyen, Md, PhD, Pr",{"name":43,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":69,"role":70,"phone":25,"phoneExt":25,"email":25},"Pascal Hot, Pr","SUB_INVESTIGATOR",{"type":72,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[74],{"name":75,"class":6},"Laboratoire de Psychologie et NeuroCognition","100548578","clinical-evaluation-of-hrv-biofeedback-in-functional-neurological-disorders-compared-to-placebo-100548578",false,"NCT06422819","Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo","Probing the Heart Rate Variability Biofeedback as an Innovative and Non-invasive Treatment for Functional Neurological Disorders Guided by a Multimodal Approach of Autonomic Nervous System.","HRV_BFB_FND","Inclusion Criteria:\n\n* Functional Neurological Disorders (FND) diagnosis must be medically established\n* Participants must have a smartphone (android ou Iphone)\n* Participants must be of the age of majority\n* Participants must have signed an informed consent\n* Sufficiently fluent in French to understand study documents and instructions\n* Consistency in performing repeated questionnaires\n* Normal or corrected-to-normal visual acuity\n\nExclusion Criteria:\n\n* Specially protected participants: juveniles, pregnant womens, nursing mothers, law's protection peoples\n* Participants suffering from a severe psychiatric disease needing specialised attention\n* History of severe neurosurgical pathology\n* Alcohol dependence or drug use\n* Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)\n* Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)\n* Participants placing under judicial or administrative supervisions","ALL","18 Years","70 Years",{"count":88,"type":89},31,"ESTIMATED","INTERVENTIONAL",[92],"NA","Evaluation of the clinical effects of the Heart Rate Variability biofeedback training with patients suffering from Functional neurological Disorders compared with placebo.",[95],"Functional Neurological Disorder",[95,97,98,99,100,101],"Emotional dysregulation","Autonomic nervous system","Endophenotypes","Biofeedback of Heart Rate Variability","Transdiagnostic approach","2024-09-10",{"date":104,"type":105},"2024-09-19","ACTUAL",{"date":107,"type":105},"2024-09-09",{"date":109,"type":89},"2027-05",{"name":5,"class":6},1]