[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592369":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":10,"centralContacts":58,"locations":10,"responsibleParty":68,"collaborators":70,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":10,"studyType":89,"phases":10,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":100,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":10},{"fullName":5,"class":6},"King's College London","OTHER",[8,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"PoTS with pain",null,"Participants with PoTS with an additional diagnosis of FMS",[13,14,15,16,17,18],"Other: Questionnaire and Physical Exam","Diagnostic Test: Nerve conduction studies","Diagnostic Test: Microneurography","Diagnostic Test: Quantitative Sensory Testing","Diagnostic Test: Skin biopsy","Biological: Blood Product",{"label":20,"type":10,"description":21,"interventionNames":22},"PoTS without pain","Participants with PoTS without pain",[13,14,15,16,17,18],{"label":24,"type":10,"description":25,"interventionNames":26},"FMS","Participants with FMS without dysautonomia",[13,14,15,16,17,18],{"label":28,"type":10,"description":29,"interventionNames":30},"Healthy volunteers","Healthy volunteers with no diagnosed autoimmune, chronic pain, or dysautonomia condition.",[13,14,15,16,17,18],[32,36,41,45,49,53],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Questionnaire and Physical Exam","Standardised participant questionnaires assessing neurological symptoms, including pain (NPSI, DN4, BPI), fatigue (Fatigue Severity Scale), depression and anxiety (PHQ9 and GAD7) and autonomic dysfunction (Malmo PoTS Score and COMPASS-31).",[24,28,9,20],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"DIAGNOSTIC_TEST","Nerve conduction studies","Measures how fast an electrical impulse moves through sensory and motor nerves. The test will be used to identify\u002Frule out large fibre peripheral neuropathy.",[24,28,9,20],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"Microneurography","Electrophysiological technique that can record action potentials from individual peripheral nerve axons in humans. The test will be used to identify\u002Frule out small nerve fibre dysfunction.",[24,28,9,20],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"Quantitative Sensory Testing","Measures psychophysical sensory perception in response to different types of stimuli, such as thermal, mechanical, pressure and vibration. The test will be used to identify\u002Frule out nerve fibre dysfunction, by generating a quantitative sensory profile of different sensory modalities.",[24,28,9,20],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Skin biopsy","Safe and minimally invasive procedure to quantify intraepidermal nerve fibres density (IENFD). Reduced IENF density is associated with small fibre neuropathy.",[24,28,9,20],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":10},"BIOLOGICAL","Blood Product","A blood sample of a maximum of 120ml will be collected from a superficial upper limb vein. Blood aliquots (50ml tubes) will then be centrifuged to separate serum from the peripheral blood cells.",[24,28,9,20],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":10,"email":63},"David Andersson","CONTACT","+447986420716","david.andersson@kcl.ac.uk",{"name":65,"role":61,"phone":66,"phoneExt":10,"email":67},"Ana Ribeiro","+447768974020","anaribeiro@nhs.net",{"type":69,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[71,73],{"name":72,"class":6},"King's College Hospital NHS Trust",{"name":74,"class":6},"Guy's and St Thomas' NHS Foundation Trust","100592369","auto-immune-contribution-in-symptom-based-sensory-and-autonomic-disorders-100592369",false,"NCT06992531","Auto-immune Contribution in Symptom-based Sensory and Autonomic Disorders","ACSSAD","Inclusion Criteria:\n\n* Between 18 and 80 years of age.\n* In the capacity to understand and sign an Informed Consent Form.\n* Willing and able to comply with scheduled visits and study procedures.\n* Diagnostic criteria for participants:\n* PoTS: following Heart Rhythm Society Expert Consensus Statement criteria, 2015, with or without comorbid FMS.\n* FMS: following the American College of Rheumatology criteria 2016, with Fibromyalgia Impact Questionnaire (FIQ) exceeding 50, and with an average pain intensity exceeding 5.5.\n* Healthy volunteers: no diagnosed autoimmune, chronic pain, or dysautonomia condition.\n\nExclusion Criteria:\n\n* Previous diagnosis of an established autoimmune condition or dermatological conditions affecting skin afferents (e.g. psoriasis, lupus, vitiligo, dermatitis…).\n* Application of local anaesthetics or steroid injections within 35 days prior to the microneurography visit.\n* Current use of anticoagulant therapy.\n* History of peripheral neuropathy or conditions usually associated with peripheral neuropathy, such as Diabetes Mellitus, Vitamin B12 deficiency, Lyme disease, a screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or antibodies against human immunodeficiency viruses 1 and 2.\n* Pregnancy.\n* Difficulties in locating the nerve (i.e. nerve cannot be seen or palpated) or previously known trauma or surgery in the area innervated will be a criterion for the exclusion of the participant for this part of the study.\n* History of regular alcohol consumption (exceeding 14 units per week) or recent alcohol consumption exceeding 14 units per week over the last 6 months (14 units is equivalent to 7 pints \\[568 mL\u002Fpint\\] of beer at 3.6% alcohol by volume or 6 standard glasses \\[176 mL\u002Fglass\\] of wine at 12% alcohol by volume).\n* Excessive consumption of caffeinated beverages (e.g., coffee, tea, cola, energy drinks), is defined as greater than 6 servings per day (1 serving\u002F236 mL equals approximately 120 mg of caffeine).\n* A history of drug abuse or addiction within 2 years before study, current regular or recreational use of marijuana (or any cannabis derivative).",true,"ALL","18 Years","80 Years",{"count":87,"type":88},250,"ESTIMATED","OBSERVATIONAL","Postural Orthostatic Tachycardia Syndrome (PoTS) is a condition where the heart rate increases when standing up, causing symptoms like dizziness and fainting. It primarily affects young women and can be very disabling, impacting daily life. In addition to the typical symptoms related to standing, people with PoTS also experience unexplained pain and fatigue, which worsen their quality of life. The exact causes of PoTS are still unknown, but it is often triggered by viral infections and some PoTS patients show signs of immune system involvement, such as the presence of certain autoantibodies and other autoimmune conditions. Research on other chronic pain disorders, including fibromyalgia syndrome (FMS), has found that autoantibodies can cause pain by affecting how the nerves work. This study aims to investigate if similar immune-related mechanisms are behind the widespread pain seen in PoTS. This study will also look at how PoTS affects the nervous system by testing nerve activity in participants and assessing the number of nerve fibres in the skin, to check if similar changes can be seen in mice. This study will also involve participants with fibromyalgia syndrome and healthy volunteers.",[92,93],"Postural Orthostatic Tachycardia Syndrome (POTS)","Fibromyalgia (FM)",[95,96,97,98,99],"Postural orthostatic Tachycardia Syndrome","Fibromyalgia Syndrome","Widespread pain","Autoantibodies","Autonomic and sensory functions","NOT_YET_RECRUITING","2025-05-27",{"date":103,"type":104},"2025-05-28","ACTUAL",{"date":106,"type":88},"2025-10",{"date":108,"type":88},"2030-10",{"name":5,"class":6}]