[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-fiber-neuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-fiber-neuropathy":166},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,83,102,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100324827","medico-economic-and-quality-of-life-impact-of-sjogren-associated-small-fiber-neuropathy-100324827",false,"NCT03509064","Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy","The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales (SF36, DN4, PROFAD SSI, ESPRI)","SFINESS-QoLEco","Inclusion Criteria:\n\n* Definite primary Sjögren syndrome\n* Age over 18 years\n* No biologics nor immunoglobulin therapy during the 6 months before study onset\n\nArm 1: patients with a small fiber neuropathy defined by the presence of a clinical AND one paraclinical abnormality\n\n* (i) Clinical signs of small fibers involvement: thermo-algic sensory deficit or autonomic dysfunction or neuropathic pain with DN4 ≥4;\n* AND\n* (ii) Small fibers neurophysiological abnormalities (QST, laser evoked potentials, autonomic nervous system tests (sympathetic skin response test or Sudoscan®)\n* OR\n* (iii) abnormal intraepidermal nerve fiber density (skin biopsy)\n\nArm2 (control group): patients without signs of peripheral neuropathy (small or large fiber)\n\nExclusion Criteria:\n\n* Presence of other causes of peripheral neuropathy\n\n  * Acquired: Diabetes, AL amyloidosis, Alcoholism, celiac disease, Drugs, toxic, HIV, Sarcoidosis, systemic vasculitis, Guillain-Barré syndrome.\n  * Hereditary: Transthyretin hereditary amyloidosis (TTR), hereditary sensory and autonomic neuropathy (HSAN), Fabry's disease\n* Patients with impaired thermo-algic sensitivity and \u002F or dysautonomia and \u002F or pain with DN4 ≥ 4 AND normal diagnostic tests (normal neurophysiological tests AND normal skin biopsy) are excluded.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","BACKGROUND Sjögren's syndrome is an autoimmune disease whose prevalence is estimated between 200 and 500 patients per 100,000 persons in France (120 to 500,000 patients). It affects women (90%) between 40 and 60 years of age and main manifestations are generalized sicca syndrome (ocular, oral, cutaneous) and arthralgia. In 20% of cases, Sjögren's syndrome is associated with peripheral neuropathies, and the most common form is painful small fiber neuropathy (SFN). SFNs are mainly featured by neuropathic pain including burns (90%), numbness (87.5%), tingling (72.5%), electric shocks (70%) and tingling (82.5%) and also autonomic disorders (50 to 70%).\n\nHowever, there are still important issues that deserve to be investigated by clinical and basic research. Among these issues, this study will focus on:\n\n* The impact of SFN on the quality of life of patients with Sjögren's syndrome.\n* The medico-economic impact of the SFN taking into account the repercussions on the quality of life, including professional life, usual care cost (analgesics, medical and paramedical consultations, hospitalizations or emergency).\n\nEXPECTED RESULTS\n\n* Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN\n* Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment.\n* Evaluation of the cost attributed to the presence of an SFN in patients with Sjögren's syndrome and the pharmaco-economic interest of conventional therapeutic management (analgesic treatment, consultation pain) compared to the cost of more aggressive immunomodulatory treatments.",[25,26,27,28],"Primary Sjögren Syndrome","Small Fiber Neuropathy","Quality of Life","Medico-economic Impact",[30,31,32,33],"Primary sjogren syndrome","Small fiber neuropathy","Quality of life","Medico-economic impact","RECRUITING","2026-02-04",{"date":37,"type":38},"2026-02-05","ACTUAL",{"date":40,"type":38},"2019-01-14",{"date":42,"type":21},"2027-01-14",{"name":44,"class":45},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":46},"100374281","phase-2-ivig-in-the-treatment-of-autoimmune-small-fiber-neuropathy-with-ts-hds-fgfr-3-or-plexin-d1-antibodies-100374281","NCT04153422","IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies","Intravenous Immunoglobulin (IVIG) in the Treatment of Small Fiber Neuropathy Due to TS-HDS, FGFR-3, or Plexin D1 Antibodies: a Double Blinded Placebo-controlled Phase II Trial","Inclusion Criteria:\n\n1. Patients ≥ age 18\n2. Patient with clinical and biopsy evidence of pure small fiber neuropathy (with or without dysautonomia) as evidenced by reduced IENFD on skin biopsy using PGP 9.5 as the immunostain. Biopsy must have been performed within 12 months of study enrollment. If biopsies were not done at CRL, they will be repeated and done at 3 sites (upper and lower thigh, lower calf), to have consistent and equivalent biopsy data with the follow up biopsy done after 6 mos of treatment\n3. Patients must have elevated and\u002For abnormal titers of autoantibodies to TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 measured by the Washington University Neuromuscular Laboratory (St Louis) within 12 mos of enrollment\n4. Patients must have a baseline pain score on a visual analogue scale (VAS) of Greater or equal to 4\u002F10\n5. Patients must have a baseline Utah Early Neuropathy Scale (UENS) score of Greater or equal to 4\u002F10\n6. Small Fiber Neuropathy Screening List (SFNSL) score of 11\u002F84 or greater\n7. Non-pregnant, non-lactating female. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during treatment\n\nExclusion Criteria:\n\n1. Any other known cause for small fiber neuropathy other than the presence of the elevated titers of TS-HDS-IgM, FGFR3-IgG, or Plexin-D1 autoantibodies\n2. Patients with generalized, severe musculoskeletal conditions other than SFN that prevent a sufficient assessment of the patient by the physician\n3. Electromyography\u002Fnerve conduction study (EMG\u002FNCS) evidence of large fiber polyneuropathy, to be confirmed by study PI\n4. Underlying severe heart, kidney, liver disease, or HIV infection, (Note: If there is no previous HIV test result documented within the last 5 years, a test may be performed in order to confirm eligibility)\n5. Patients with a history of deep vein thrombosis within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis\n6. Known significant IgA deficiency with antibodies to IgA\n7. History of hypersensitivity, anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of IVIG 10%\n8. Known blood hyperviscosity, or other hypercoagulable states\n9. Use of IgG products within six months prior to enrollment\n10. Patients with a history of drug or alcohol abuse within the past five years prior to enrollment\n11. Patients unable to understand or unwilling or unable to comply with the study protocol",{"count":55,"type":21},20,"INTERVENTIONAL",[58],"PHASE2","This study will enroll patients with small fiber neuropathy (SFN). The study will look at an intravenous immunoglobulin (IVIG) called Panzyga. Panzyga is approved by the FDA as a therapy for Primary humoral immunodeficiency (PI) in patients 2 years of age and older; Chronic immune thrombocytopenia (ITP) in adults and Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. It has not been approved by the FDA for use in SFN.\n\nThere is mounting evidence that Intravenous Immunoglobulin (IVIG) can cause pain reduction and improve objective nerve fiber densities on skin biopsies in great numbers in SFN patients. The primary outcome is quantified improvement in intraepidermal nerve fiber density (IENFD) on repeat skin punch biopsy after 6 months of IVIG treatment.",[26,61,62,63],"Autoimmune Small Fiber Neuropathy","Inflammatory Polyneuropathy","Immune-Mediated Neuropathy",[26,65,66,67,68,69,70,71,72,73],"Neuropathy","Intravenous Immunoglobulin","IVIG","TS-HDS antibody","FGFR-3 antibody","FGFR3 antibody","Immune mediated small fiber neuropathy","Panzyga","Plexin D1 antibody","2026-01-07",{"date":76,"type":38},"2026-01-09",{"date":78,"type":38},"2023-12-15",{"date":80,"type":21},"2028-02-28",{"name":82,"class":45},"Endeavor Health",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":46},"100420798","detection-of-small-fiber-neuropathy-using-skin-properties-100420798","NCT04759443","Detection of Small Fiber Neuropathy Using Skin Properties","Inclusion Criteria:\n\n* Patients with age 18 year or older\n* Patients that sign the informed consent form to participate in this study\n* Patients completed the autonomic testing with skin biopsies\n\nExclusion Criteria:\n\n* Patients with significant hairs at the legs that will cover the skin\n* Any dermatological disorder that can affect the skin composition\n* The use of skin lotion",{"count":90,"type":21},400,"Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.",[26],"2025-02-04",{"date":95,"type":38},"2025-02-06",{"date":97,"type":38},"2021-07-01",{"date":99,"type":21},"2027-02-01",{"name":101,"class":45},"Brigham and Women's Hospital",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":113,"studyType":22,"phases":4,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100386354","autonomic-small-fiber-neuropathy-and-ehlers-danlos-syndromes---prospective-study-and-registry-100386354","NCT04310644","Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry","Autonomic Neuropathy and Its Pathophysiology in Autoimmune Autonomic Neuropathies, Postural Orthostatic Tachycardia Syndrome and Ehlers Danlos Syndromes: Peripheral Autonomic Small Fiber Neuropathy or Central Autonomic Failure? Validation of the Malmö POTS Score and a Better Diagnosis of POTS in Patientes With Autnomic Failure (VaGeMAPS-3-step-Diag)","ProANS","Inclusion Criteria:\n\n* autonomic neuropathy\n* Postural orthostatic tachycardia syndrome\n* hypermobile or classical Ehlers Danlos syndromes\n* Chronic fatigue syndrome, mast cell activation syndrome and\u002For PostCOVID\n* healty controls\n* between 18-80 years\n* in patients: diagnosis and clinical testing in our outpatient clinic\n* German speaking\n\nExclusion Criteria:\n\n* pregnancy\n* Pacemaker or Deep brain Stimulation\n* sensory or motor Polyneuropathy\n* neurodegenerative disease","80 Years",{"count":112,"type":21},200,"5 Years","We examine patients with different autonomic neuropathies and Ehlers Danlos syndromes compared to healthy controls at three different points over time (baseline, after 3 months and after 1.5 years) to gain knowledge about the course of this disease and understand its pathophysiology, with a focus on Small Fiber neuropathy. Moreover we will validate the german version of the Malmö POTS Score and establish an easy diagnostic scheme for patients in outpatient care.",[116,117,26,118],"Autonomic Neuropathy","Ehlers-Danlos Syndrome Hypermobility Type","Postural Tachycardia Syndrome","2025-02-03",{"date":93,"type":38},{"date":122,"type":38},"2019-09-15",{"date":124,"type":21},"2029-09-15",{"name":126,"class":45},"RWTH Aachen University",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":56,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":4},"100530148","phase-4-ivig-in-painful-sensory-neuropathy-100530148","NCT06183008","IVIG in Painful Sensory Neuropathy","Effect of Intravenous Immunoglobulins on Painful Sensory Neuropathy Evaluated by Aggregated N-of-one Trials","Inclusion Criteria:\n\nPainful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or sensory neuronopathy\n\n* Idiopathic small fiber neuropathy (all of the following)\n\n  1. Neuropathic pain (length-dependent\u002Fnon-length dependent\u002Ffocal) and at least two of the following clinical signs\n\n     1. Hypoesthesia (tactile, pinprick, or thermal)\n     2. Allodynia (tactile, dynamic, thermal, pressure)\n     3. Hyperalgesia\n     4. Aftersensation\n  2. Normal nerve conduction studies:\n  3. Reduced intra-epidermal nerve fiber density at the distal leg (IENFD) at the distal leg or Reduced thermal threshold assessed at the foot by QST\n  4. Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy\n* Sensory neuronopathy (all of the following)\n\n  1. Clinical pure sensory neuropathy\n  2. A score \\>6.5 on the following\n\n     1. Ataxia in the lower or upper limb: 3.1p\n     2. Asymmetrical distribution of sensory loss: 1.7p IVIGSeN Protocol number 1.2\n     3. Sensory loss not restricted to the lower limb at full development: 2.0 p\n     4. At least 1 sensory action potential absent or 3 sensory action potentials \\\u003C30% of the lower limit of normal in the upper limbs not explained by entrapment neuropathy: 2.8p\n     5. Less than two nerves with abnormal motor nerve conduction studies in the lower limbs: 3.1p\n  3. Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy\n\nPain intensity \\> 5.0 on a pain score from 0-10, lasting at least 4 weeks\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Previous allergic reaction to IVIG or other blood products)\n2. Selective IgA deficiency\n3. Cardiac insufficiency (NYHA III\u002FIV ie marked or severe limitation in activity due to symptoms, even during less-than-ordinary activity)\n4. Cardiac dysrhythmia requiring treatment\n5. Unstable or advanced ischemic heart disease\n6. Severe hypertension (diastolic \\>120 or systolic \\> 170)\n7. Known hyperviscosity\n8. Renal insufficiency (GFR \\\u003C 30 ml\u002Fmin\u002F1,73m2) or nephrotic syndrome\n9. Previous thromboembolic event\n10. Smoking\n11. Diabetes\n12. Prolonged immobilization\n13. Hypercoagulable state\n\n    Prior\u002FConcomitant Therapy\n14. Change of pain medication in the 30 days prior to inclusion (unchanged pain medication is allowed, provided dosages stay equal during the study)\n15. Treatment with IVIG the last 4 weeks or other ongoing immunomodulatory treatments\n16. Use of loop diuretics, Dinutuksimab beta, or Imlifidase Diagnostic assessments\n17. Predominant clinical or neurographic features of motor nerve fiber involvement Other Exclusions\n18. Females who are breastfeeding, pregnant or unwilling to practice contraception throughout the study\n19. Unable to give independent informed consent","65 Years",{"count":55,"type":21},[137],"PHASE4","The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.",[140,26],"Sensory Neuropathy",[142,143,144,145,146,147,67,148,149,150,151,152,153,154],"nervous system diseases","neuromuscular diseases","peripheral nervous system diseases","small fiber neuropathy","sensory neuronopathy","sensory neuropathy","Intravenous immunoglobulin","n-of-1","Sørlandet sykehus","Sorlandet hospital","Kristiansand","polyneuropathy","Intravenous immune globulin","NOT_YET_RECRUITING","2023-12-13",{"date":158,"type":38},"2023-12-27",{"date":160,"type":21},"2024-02",{"date":162,"type":21},"2028-12",{"name":164,"class":165},"Sorlandet Hospital HF","OTHER_GOV","Small-Fiber Neuropathy"]