[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-treatment-lyme-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-treatment-lyme-disease":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,63,95,117],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100546657","navigating-pregnancy-and-parenthood-with-lyme-disease-100546657",false,"NCT06397794","Navigating Pregnancy and Parenthood With Lyme Disease","Mixed Methods Study on Navigating Pregnancy and Parenthood With Lyme Disease","Inclusion Criteria:\n\n* Over 18 years of age and reside in the United States or Canada\n* Diagnosed with acute Lyme disease, PTLDS, and\u002For Chronic Lyme by a health care provider while they were pregnant OR PTLDS\u002FCL prior to becoming pregnant with ongoing symptoms during pregnancy\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Live outside of the United States or Canada\n* Never been diagnosed with Lyme disease by a medical provider\n* Never been pregnant\n* Never given birth to a liveborn infant\n* Previously participated in a qualitative study about their experience with Lyme disease\n* Do not want to agree to having their interviews audio recorded","FEMALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","OBSERVATIONAL","This is a mixed methods study exploring the experiences of pregnancy and parenting among participants with Lyme disease. Eligible participants will have been diagnosed with Lyme disease (LD), post-treatment Lyme disease syndrome (PTLDS), and\u002For chronic Lyme (CL) either during or before a prior pregnancy. Participants will complete quantitative surveys on topics such as their medical history, their child(ren)'s development, and demographic information. They will then participate in a qualitative interview where they will be asked about their experiences with pregnancy and with parenting their child(ren) in the context of their condition.",[24,25,26,27,28,29,30],"Lyme Disease","Post Treatment Lyme Disease","Chronic Lyme Disease","Tick-Borne Infections","Tick-Borne Diseases","Pregnancy Complications","Parenting","RECRUITING","2026-06-15",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2024-03-20",{"date":39,"type":20},"2026-12",{"name":41,"class":42},"Children's National Research Institute","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":43},"100518163","pregnancy-and-early-neurodevelopmental-outcomes-following-in-utero-lyme-disease-exposure-100518163","NCT06026969","Pregnancy and Early Neurodevelopmental Outcomes Following In Utero Lyme Disease Exposure","Inclusion Criteria:\n\n* English speaker\n* Currently reside in the United States or Canada\n* Meet CDC criteria for: (1) clinical and\u002For laboratory diagnosis of Lyme disease during any stage of current pregnancy, OR (2) clinical diagnosis of PTLDS\u002FChronic Lyme within 3 years of current pregnancy\n* Able to be contacted for follow-up\n\nExclusion Criteria:\n\n* Intellectually unable to comprehend study procedures\n* Health issues or metallic implant that precludes undergoing MRI\n* Incapable of completing study requirements (note: inability to travel to Children's National for in-person follow-up \\[for example, due to bedrest, travel restrictions, or financial inability to travel\\] is NOT an exclusion criterion; any interested and eligible participants requiring \"remote only\" participation will be permitted to join the study and complete all requirements besides in-person follow-up)","ALL",{"count":52,"type":20},40,"The purpose of this pilot study is to assess the feasibility of longitudinal neurodevelopmental evaluation of fetuses and infants exposed to Lyme disease in utero. Participants with Lyme disease or Post-Treatment Lyme Disease Syndrome (PTLDS) will be recruited during pregnancy. Pregnancies will be monitored and infant development will be assessed from birth until age 18 months.",[24,55,26,27,29,56],"Post-Treatment Lyme Disease","Child Development",{"date":58,"type":35},"2026-06-16",{"date":60,"type":35},"2023-07-01",{"date":39,"type":20},{"name":41,"class":42},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100586434","transcranial-direct-current-stimulation-for-post-treatment-lyme-disease-100586434","NCT06915324","Transcranial Direct Current Stimulation for Post Treatment Lyme Disease","Transcranial Direct Current Stimulation (tDCS) of Brain Fog in Patients With Post Treatment Lyme Disease","Inclusion Criteria:\n\n* History of diagnosis of Lyme disease by a health care provider, meeting criteria for either definite or probable or possible LD\n* Willingness to provide documentation of prior LD testing and\u002For related medical records\n* Total prior antibiotic treatment for LD was at least 2 courses of antibiotic therapy\n* Have cognitive symptoms attributed to Lyme disease that have persisted or returned despite antibiotic therapy\n* Current cognitive symptoms interfere with function and\u002For cause distress\n* Have evidence of slowed processing speed on a screening measure\n* Participant is willing to be off of antibiotic treatment for tick-borne disease for at least 4 weeks prior to final determination of study eligibility and for the duration of the 12-week study.\n* Participant expresses willingness to not start new medications that might affect treatment outcome during the trial (unless medically necessary), and willingness to inform study staff regarding any changes in medication\n* Live in the US or Canada and comfortable speaking English\n* Age 18-70\n* Stable and continuous access to internet service\n* Adequate home facilities (enough space, access to quiet and distraction free area)\n* Able to commit to the 12-week study period (4 weeks of training sessions and an 8-week post treatment visit)\n* Estimated intellectual ability \\>= 85\n\nExclusion Criteria:\n\n\\- Medical Illness: Any of the following: a. Unstable non-Lyme-related chronic medical illness over the last 12 months (e.g., cancer, acute myocardial infarction, labile hypertension) b. Any severe skin disorder or skin sensitive area near stimulation locations (e.g. forehead)\n\nNeurologic: Any of the following:\n\n* History of traumatic brain injury with persistent post-concussive symptoms\n* History of seizure disorder or recent (\\\u003C5 years) seizure history\n* History of neurosurgery to the head\n* Chronic headaches or migraines of moderate to severe intensity within the last month\n* Post stroke deficits that may interfere with assessment\n* Any progressive neurodegenerative disorder or other neurological disorders that may interfere with assessment at discretion of the investigator.\n\nPsychiatric: Any of the following:\n\n* History of intellectual disability, or other developmental neurological condition associated with cognitive impairment\n* Current primary psychiatric disorder that would interfere with ability to participate\n* Current alcohol or other substance use disorder\n* Current suicide risk as assessed by the C-SSRS (any level)\n* History of suicidal behavior over the last year\n* History of a diagnosis of a psychotic disorder, mania or bipolar disorder\n* Depression rating of moderate or severe at screening\n\n  * Currently taking opiate-based medications, dissociative drugs (prescribed or illicit), or other medication considered likely to interfere with treatment outcome at the discretion of the investigator. The use of a stable dose of benzodiazepines, anticholinergic agents and non-narcotic pain medications is permitted. The use of an occasional dose of these medications is also permitted, but not within 48 hours of neurocognitive study assessments.\n  * Participants whose current daily medication regimen has not been stable for a minimum of 4 weeks prior to final determination of study eligibility\n  * Medical device implanted in the head (such as a Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator), or metal implants in the head or neck\n  * Inadequate visual or motor skills needed for regular computer use or to operate study equipment, or inability to provide informed consent\n  * Individuals who are pregnant or breastfeeding or planning to become pregnant\n  * Lifestyle Considerations: Participants not willing to refrain from beginning, resuming or increasing non study cognitive training or cognitive enhancing supplements\u002Fmedications or other therapies that might affect treatment outcome","70 Years",{"count":72,"type":20},110,"INTERVENTIONAL",[75],"NA","The primary purpose of this pilot study is to investigate a novel approach to the treatment of cognitive symptoms that persist despite prior antibiotic treatment for Lyme disease (Post treatment Lyme Disease or PTLD).\n\nAim 1: The primary aim of this study is to assess whether the processing speed of individuals with PTLD can be enhanced by combining transcranial direct current stimulation (tDCS) with computer based cognitive training games. To achieve this aim, over a 4-week period, all individuals with PTLD will participate in at home adaptive cognitive training combined with either active stimulation or sham stimulation.\n\nAim 2: To determine if treatment benefit in processing speed is sustained, the study will compare the sham and active groups 8 weeks after completion of study treatment.",[55],[79,80,81,82,83,24,84],"tDCS","Cognitive training","Neuromodulation","Brain Fog","Brain Stimulation","Chronic Lyme","2026-05-01",{"date":87,"type":35},"2026-05-06",{"date":89,"type":35},"2025-07-14",{"date":91,"type":20},"2027-08",{"name":93,"class":42},"Columbia University",2,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":73,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":116,"locationsCount":43},"100498899","tavns-for-persistent-symptoms-from-lyme-disease-100498899","NCT05776251","taVNS for Persistent Symptoms From Lyme Disease","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Persistent Symptoms From Lyme Disease: a Feasibility, Tolerability, and Safety Study","Inclusion Criteria:\n\n* History of either Definite or Highly Probable Past Lyme disease diagnosed and treated by a health care provider more than 6 months previously.\n* Have one or more current symptoms attributed to Lyme disease that were also present during the initial 6-month period after diagnosis and antibiotic treatment of Lyme disease.\n* Individuals reporting that current symptoms cause clinically significant distress or impairment in functioning.\n* Previously treated for Lyme disease with at least two courses of antibiotics considered appropriate for Lyme disease.\n* Individuals who agree to not start a new medical or psychiatric treatment (that might impact study outcomes) for their chronic symptoms during the course of this study (unless deemed necessary by their primary care physician (PCP)).\n* Individuals whose current treatment (that might impact study outcomes) has been stable for at least 6 weeks prior to baseline visit.\n* Lives in the U.S. and owns a smartphone, tablet or computer with Internet access.\n* Able to read and understand English to be able to provide informed consent.\n* Able and willing to come to Columbia University Irving Medical Center in NYC for 3-5 study visits.\n* Willingness to have a 12-lead electrocardiogram (EKG) when evaluated on site and, if an EKG was conducted in the past year, willingness to try to obtain that EKG for us to review.\n* Current moderate to severe fatigue. At least moderate intensity at study screening (a score of 4 or more on the Fatigue Severity Scale (FSS)).\n* Ability to allocate sufficient time for the treatment sessions, including 6 sessions that will be monitored during work hours (8 am to 6 pm).\n\nExclusion Criteria:\n\n* Current or past history of cardiovascular disorder(s) (coronary artery disease, peripheral artery disease, stroke, aortic disease, or other major cardiac condition). A history within the last year of unexplained fainting spells or of vasovagal syncope or feeling faint in response to medical settings or pain. Symptomatic bradycardia, orthostatic (postural) hypotension not correctable by fluid intake (i.e., a drop of \\>20 mm Hg systolic, 10 mm Hg diastolic or both), or persistent hypotension (BP below 90 mmHg systolic).\n* Abnormal EKG findings (e.g., significant bradycardia) considered significant by a cardiologist.\n* A diagnosed current major central nervous system disease (e.g., multiple sclerosis (MS), epilepsy, neurodegenerative diseases, ischemic stroke, Parkinson's, traumatic brain injury with cognitive impairment, etc.) or a history of brain surgery or brain tumors.\n* A current psychiatric disorder that might impact treatment compliance (e.g., bipolar disorder, psychosis, substance abuse).\n* Suicidal ideation with method, plan or intent in the last 6 months or a lifetime history of suicidal behavior.\n* Current moderate-severe or severe depression (T-score of 65 or higher on the PROMIS-Emotional Distress-Depression SF) at screening.\n* Current serious unstable medical illness.\n* Currently taking opiate-based medication or have taken antibiotics in the last 6 weeks for tick-borne illness.\n* Ear-related: a) facial or ear pain; b) recent ear trauma; c) damage to left or right ear or anatomy that does not allow taVNS; d) ear infection (otitis media or externa); e) scar or inflammation on ear; f) Cochlear implants.\n* Currently or recently (within 6 months) in a clinical trial of an investigational medicinal product or another medical device.\n* Females who are pregnant or planning to become pregnant during the course of this study.\n* Unable to connect to the Internet during treatment phase.\n* Individuals with an active external or implanted electrical medical device (e.g., cardiac pacemaker, hearing aid implant) or any metal implant above the level of the neck.\n* Individuals who have had surgery to cut the vagus nerve in the neck (cervical vagotomy).","65 Years",{"count":104,"type":20},24,[75],"This study is one of the first studies to investigate a non-antibiotic approach to the treatment of symptoms that persist after antibiotic treatment for Lyme disease (PTLS). Transcutaneous auricular vagus nerve stimulation (taVNS) offers the potential of being an effective and non-toxic approach to reduce the burden of multisystem symptoms in patients with PTLS. This study seeks to address an important goal: to assess the safety, feasibility, and tolerability of a new non-invasive, non-pharmacologic treatment for patients with symptoms that persist despite prior antibiotic treatment for Lyme disease.",[55],[24,109,110,111,55],"Vagus Nerve Stimulation","taVNS","Fatigue",{"date":87,"type":35},{"date":114,"type":35},"2023-05-08",{"date":39,"type":20},{"name":93,"class":42},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":73,"phases":127,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":141,"locationsCount":43},"100563049","early-phase-1-ceftriaxone-pulse-dose-for-post-treatment-lyme-disease-100563049","NCT06611111","Ceftriaxone Pulse Dose for Post-Treatment Lyme Disease","Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease","Inclusion Criteria:\n\n1. Age 18 to 75 at the time of consent\n2. Ability and willingness to sign informed consent\n3. Available for the study period\n4. Must have met the definition of a prior well-defined or probable Lyme disease infection, AND meet the definition of PTLDS\n5. Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit\n6. Have a level of fatigue that interferes with their ability to function in their job, schooling, or other social\u002Fpersonal activities (FSS score of 4 or higher)\n7. Subjects will need to have been off of antibiotics (those standard antibiotics used to target Lyme disease to include doxycycline, amoxicillin, cefuroxime, azithromycin, ceftriaxone or penicillin) for at least 6 weeks prior to study enrollment and be willing to remain off of any outside antibiotics during the duration of the treatment component of the study.\n\nExclusion Criteria:\n\n1. Female: pregnant or lactating\n2. Women who intend to become pregnant during the treatment study period (approximately 45 days)\n3. Patients with a diagnosis of Lyme disease based on only a positive Lyme IgM immunoblot\n4. A history of cephalosporin allergy or significant intolerance\n5. Lyme related symptoms that have been present for greater than 10 years\n6. Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus.\n\n   Note: Subjects who have well controlled HIV, who are on ART with a CD4 count greater than 200 will be allowed to participate.\n7. Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition (to include any finding of increased suicide risk as identified by a rating of moderate or high risk on the CSSRS assessment), which in the opinion of the investigator prevents the subject from participating in the study\n8. Known concurrent rheumatologic or similar disease thought to interfere with study participation or confound results at the discretion of the investigator. These may include but are not limited to rheumatoid arthritis, systemic lupus erythematous, Sjogren's syndrome, scleroderma, psoriasis, fibromyalgia, chronic fatigue syndrome\u002Fmyalgic encephalomyelitis, or obstructive sleep apnea\n9. Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous treatment with a cephalosporin antibiotic, or severe allergic reaction to penicillins (e.g. anaphylaxis or severe rash with Stevens Johnson syndrome or similar)\n10. Planned travel during the study period that would interfere with the ability to complete all study visits (this can be a temporary exclusion with plan to schedule enrollment during a window of time during which they could attend their study visits)\n11. Significant screening physical examination abnormalities or chronic medical condition that in the opinion of the investigator may impact subject safety\n12. 12\\. Participation (active or follow-up phase) or planned participation in another vaccine, drug, or medical device in the 4 weeks prior to this trial, within 5 times the elimination half-life, whichever is longer, or during the trial\n13. Prior history of Clostridium difficile infection\n14. Currently taking warfarin (Coumadin)\n15. Unable to comply with study requirements\n16. Clinician discretion","75 Years",{"count":126,"type":20},44,[128],"EARLY_PHASE1","The goal of this clinical trial is to learn if an FDA approved drug, Ceftriaxone, given intermittently, can treat people between 18 and 75 years old with a history of Lyme disease, who are still experiencing persistent or returning symptoms after they have completed treatment. The main questions it aims to answer are:\n\n* Will giving Ceftriaxone approximately every 5 days for 6 weeks be safe and well tolerated when compared to a group that receives placebo (a look-alike substance that contains no drug)?\n* Will giving Ceftriaxone improve symptoms?\n\nParticipants will be asked to do the following:\n\n* Come to the clinic approximately every 5-6 days to receive an IV infusion of either the Ceftriaxone or placebo.\n* Answer questions about their level of tiredness, body pain, general health and physical ability, sleep, anxiety, depression and any suicidal thoughts.\n* Give blood so we can make sure your body is handling the drug okay or to help us learn more about how the drug is affecting the persistent Lyme disease symptoms.",[55],[132,133,134,26],"Pulse Dose","Ceftriaxone","PTLDS","2026-03-18",{"date":137,"type":35},"2026-03-19",{"date":139,"type":35},"2025-02-03",{"date":39,"type":20},{"name":142,"class":42},"State University of New York - Upstate Medical University"]