[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-treatment-lyme-disease-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-treatment-lyme-disease-syndrome":158},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100566489","sana-device-for-post-treatment-lyme-disease-syndrome-chronic-pain-100566489",false,"NCT06655844","Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain","Extended Home-use Trial of a Novel Device to Reduce Chronic Pain","Inclusion Criteria:\n\n* Confirmed clinical diagnosis of neuropathic pain AND\n* Confirmed clinical diagnosis of Post-treatment Lyme disease syndrome\n* Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:\n\n  * Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition\n  * Erythema Migrans\n  * History of possible exposure to a high incidence county or state (or an adjacent area)\n* Erythema migrans rash\n\n  * EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)\n  * EM 1A: MOA self-report \\& medical record documentation of rash \\> 5 cm\n  * EM 1B: MOA: self-report and medical record documentation of EM rash but not size\n  * EM 1C: MOA: self-report \\& rash misdiagnosed in medical record as cellulitis\u002Fspider bite\n  * EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR Disseminated \"objective\" manifestation with lab test confirmation of Bb infection\n* Clinical history includes at least one of the following symptoms\u002Fsigns, which are not better accounted for by another cause (MOA: medical records and\u002For self-report).\n* Neurologic: Lymphocytic Meningitis; Encephalitis; Encephalomyelitis, Cranial Neuritis (especially facial palsy); Radiculoneuropathy;\n* Other Neurologic Signs (with objective measures): Encephalopathy, Polyneuropathy\n* Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis\n* Lyme arthritis: Recurrent joint swelling in one or more joints\n* Dermatologic: Disseminated EM (\"satellite\") or Acrodermatitis atrophicans AND\n* Lab test Confirmation (previous) (requires at least one of the Class 1 lab tests) (MOA: self-report \\& documentation) Group 2. Probable.\n* Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation\n* Class 1 lab test confirmation (excluding IgM WB)\n* Highly suggestive IgG WB (4 of 10 bands) OR EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR\n* Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard twotiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report)\n* Ages 18+\n* Fluent in English\n* Consistent medications for the last 4 weeks prior to the first baseline visit (week 0)\n\nExclusion Criteria:\n\n* Diagnosis of photosensitive epilepsy\n* Ear or eye infection\n* Vision impairments that affect perception of light in one or both eyes\n* Deafness in one or both ears\n* Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if participants self- report having anxiety)","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study will investigate the effectiveness of the Sana Pain Reliever (Sana PR) at reducing chronic pain.\n\nThe Sana PR is a device comprised of one main component (Mask with Earbuds) and two ancillary components (Charger and Headband). The device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into the forehead area that measures HRV throughout the use of the device.\n\nThe system runs for 15 min at a time and is not FDA approved.\n\nThe trial will last a total of 14 weeks.\n\n50 participants who have a diagnosis of Post-treatment Lyme Disease and experience chronic pain are expected to take part in this study at Mount Sinai.",[26,27],"Post-treatment Lyme Disease Syndrome","Chronic Pain","RECRUITING","2026-05-14",{"date":31,"type":32},"2026-05-18","ACTUAL",{"date":34,"type":32},"2024-10-04",{"date":36,"type":20},"2026-07-31",{"name":38,"class":39},"Icahn School of Medicine at Mount Sinai","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":40},"100555358","phase-1-lumbrokinase-for-adults-with-long-covid-post-treatment-lyme-disease-syndrome-and-myalgic-encephalomyelitischronic-fatigue-syndrome-100555358","NCT06511050","Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Inclusion Criteria:\n\n* Any gender\n* Aged 18+\n* Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information is collected as part of the baseline survey).\n* Diagnosed with only one of the following conditions:\n* Long Covid\n* Documented clinical history of confirmed or suspected acute COVID-19 infection a minimum of 3 months prior to contact with the study team\n* Formal diagnosis of Long Covid from a physician\n* Post-treatment Lyme disease syndrome\n* Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:\n\n  * Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition Erythema Migrans History of possible exposure to a high incidence county or state (or an adjacent area) Erythema migrans rash\n\n    * EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)\n    * EM 1A: MOA self-report \\& medical record documentation of rash \\> 5 cm\n    * EM 1B: MOA: self-report and medical record documentation of EM rash but not size\n    * EM 1C: MOA: self-report \\& rash misdiagnosed in medical record as cellulitis\u002Fspider bite\n    * EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR\n    * Disseminated \"objective\" manifestation with lab test confirmation of Bb infection\n    * Clinical history includes at least one of the following symptoms\u002Fsigns, which are not better accounted for by another cause (MOA: medical records and\u002For self-report).\n    * Neurologic: Lymphocytic Meningitis ; Encephalitis; Encephalomyelitis Cranial Neuritis (especially facial palsy); Radiculoneuropathy; Other Neurologic Signs (with objective measures) : Encephalopathy, Polyneuropathy\n    * Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis\n    * Lyme arthritis: Recurrent joint swelling in one or more joints\n    * Dermatologic: Disseminated EM (\"satellite\") or Acrodermatitis atrophicans AND\n    * Lab test Confirmation (requires at least one of the Class 1 lab tests) (MOA: self-report \\& documentation)\n  * Group 2. Probable\n\n    * 2A. Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation Class 1 lab test confirmation (excluding IgM WB) Highly suggestive IgG WB (4 of 10 bands) OR\n    * 2B. EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR\n    * 2C. Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR\n    * 2D. Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM)\n* (MOA: medical records, lab test and self-report)\n* (MOA: lab test and self-report)\n* ME\u002FCFS\n* Formal diagnosis of ME\u002FCFS prior to 2020 from a physician\n* Actively symptomatic such that the 2011 International Criteria for ME\u002FCFS is met at time of screening\n\nExclusion Criteria:\n\n* Current use of antiplatelet or anticoagulation regimen\n* Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.\n* Pregnancy or lactation\n* Known allergy to earthworms (Lumbrokinase is a supplement that is derived from earthworms)\n* Past medical history of a bleeding or clotting disorder\n* Has a scheduled surgery during, or immediately after, the study period",{"count":49,"type":20},120,[51,52],"PHASE1","PHASE2","This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:\n\n* Long Covid (LC)\n* Post-treatment Lyme disease syndrome (PTLDS)\n* Myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS)",[55,26,56,57],"Long Covid","Chronic Fatigue Syndrome","Myalgic Encephalomyelitis",[55,59,60,61,62],"Lyme Disease","ME\u002FCFS","Lumbrokinase","Post-treatment Lyme disease syndrome","2026-03-11",{"date":65,"type":32},"2026-03-13",{"date":67,"type":32},"2024-10-09",{"date":69,"type":20},"2026-12",{"name":38,"class":39},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":82,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":128,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":40},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform",true,"2 Years",{"count":81,"type":20},10000,"10 Years","OBSERVATIONAL","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[86,60,87,88,89,90,91,92,93,94,26,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"Post-Acute COVID-19 Syndrome","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[104,57,56,129,130,131,132,133,134,135,60,136,137,138,139,140,106,141,142,143,144,145,146,147,148],"Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":151,"type":32},"2026-01-22",{"date":153,"type":32},"2023-07-05",{"date":155,"type":20},"2030-12-31",{"name":157,"class":39},"Brain Inflammation Collaborative","Post Treatment Lyme Disease Syndrome"]