[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07221565":3,"trial-entities:NCT07221565":107,"trial-summary:NCT07221565":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":36,"primary_purpose":37,"phases":38,"enrollment_info":41,"interventions":44,"primary_outcomes":67,"secondary_outcomes":72,"sex":77,"minimum_age":78,"maximum_age":78,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":84,"locations":88,"central_contacts":97,"overall_officials":98,"references":102,"see_also_links":103},"NCT07221565","TWH-QSIT-IMMUNENET-2025-01","Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)","ImmuneNet: Quantum-Synaptic Immunotherapy Mapping","ENROLLING_BY_INVITATION","2034-10-23","2026-05","2026-05-22","2025-10-23","Truway Health, Inc.","INDUSTRY",true,"The ImmuneNet study is a Phase I\u002FII clinical trial sponsored by Truway Health, Inc. It will test whether gentle, low-frequency electromagnetic resonance (LF-EMR) can influence how immune cells communicate and synchronize with each other. The goal is to see if this \"quantum-synaptic\" signaling effect can help stabilize immune activity and reduce the number of autoimmune flare-ups in people living with conditions such as lupus, rheumatoid arthritis, or multiple sclerosis.\n\nParticipants will receive either an active or a sham (placebo) LF-EMR session three times per week for twelve weeks. Each session is completely non-invasive. Blood samples will be collected to study cytokines (immune-system messenger molecules), gene-expression patterns, and electrical field coherence among immune cells.\n\nA machine-learning system will analyze these data to predict inflammation patterns and guide individualized treatment settings. All participant data will be securely recorded and time-stamped to ensure transparency and privacy.\n\nThe expected outcome of the study is a measurable reduction in autoimmune flare frequency and symptom severity, along with improved understanding of how electromagnetic signaling might safely regulate immune function.","This exploratory, randomized, double-blind, parallel-assignment Phase I\u002FII trial is designed to evaluate the safety, tolerability, and biological activity of low-frequency electromagnetic resonance (LF-EMR) for immune modulation.\n\nRationale and Objectives Autoimmune diseases involve abnormal immune signaling that leads to chronic inflammation. Emerging biophysical evidence suggests that immune cells generate and respond to ultra-low-frequency electromagnetic fields that may coordinate cytokine release and cell communication. The ImmuneNet protocol seeks to harness this phenomenon through controlled, resonant electromagnetic exposure to promote immune homeostasis.\n\nMethods Approximately 120 adults aged 18-70 with stable autoimmune disease will be enrolled at Truway Health Research Centers in New York, NY and Austin, TX. Participants will be randomly assigned in a 1:1 ratio to active or sham LF-EMR stimulation. Active participants will receive 7-40 Hz resonant fields (\\\u003C 2 microtesla) for 20 minutes per session, three times weekly for twelve weeks. Sham participants will undergo identical procedures with the device inactive.\n\nBlood samples collected at baseline, week 6, week 12, and six-month follow-up will undergo multiplex cytokine analysis, RNA sequencing, and electrophysiologic coherence mapping. Machine-learning models will be trained to forecast cytokine cascades and flare probability.\n\nOutcome Measures The primary endpoint is reduction in documented autoimmune flare frequency over six months. Secondary endpoints include changes in serum cytokine synchronization index, transcriptomic shift magnitude, patient-reported global health scores, and adverse-event incidence.\n\nEthics and Oversight The study will follow Good Clinical Practice (GCP) guidelines and be reviewed by an independent institutional review board. Participation is voluntary, and informed consent will be obtained from all subjects.\n\nExpected Impact If successful, the trial will demonstrate a safe, non-pharmacologic approach to immune regulation and establish a data framework for future AI-guided quantum-resonant therapies. The knowledge gained could lead to new treatment options for autoimmune and chronic inflammatory diseases while reducing reliance on long-term immunosuppressive drugs.",[19,20,21,22,23,24],"Systemic Lupus Erythematosus","Rheumatoid Arthritis","Multiple Sclerosis","Autoimmune Diseases","Chronic Inflammatory Syndromes","Immune Dysregulation",[26,27,28,29,30,31,32,33,34,35],"Quantum Immunotherapy","Electromagnetic Resonance Therapy","Low-Frequency Electromagnetic Fields","Immune Cell Synchronization","Cytokine Forecasting","AI-Driven Immunomodulation","Truway Health ClinicalChain","Non-pharmacologic Immune Regulation","Autoimmune Flare Reduction","Machine Learning in Immunology","INTERVENTIONAL","TREATMENT",[39,40],"PHASE1","PHASE2",{"count":42,"type":43},120,"ESTIMATED",[45,54,60],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":52},"DEVICE","Low-Frequency Electromagnetic Resonance Therapy (LF-EMR)","A non-invasive medical device that generates low-frequency electromagnetic fields (7-40 Hz \\\u003C 2 μT) targeted at harmonizing immune-cell electromagnetic communication. Participants receive 20-minute sessions three times weekly for twelve weeks. The device is cleared for investigational use under Truway Health protocol TWH-QSIT-IMMUNENET-2025-01.",[50,51],"Active Low-Frequency Electromagnetic Resonance (LF-EMR)","Sham Electromagnetic Stimulation (Placebo Control)",[53],"Quantum-Synaptic Resonance Device (QSR-01)",{"type":46,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Sham Resonance Device (Inactive Control)","A visually identical device programmed to remain inactive and emit no electromagnetic field. Used to maintain blinding and assess placebo response. Participants follow the same treatment schedule as the active group.",[50,51],[59],"Placebo LF-EMR Unit",{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Low-Dose Naltrexone (LDN)","Participants assigned to this adjunct pharmacologic arm will receive low-dose naltrexone (4.5 mg oral capsule once daily at bedtime) for twelve weeks.\n\nLow-dose naltrexone is hypothesized to reduce pro-inflammatory cytokine activity and enhance endogenous endorphin-mediated immune regulation. The dose is well below the standard 50 mg level used for addiction therapy and has been studied for autoimmune and inflammatory disorders.\n\nThis arm will allow assessment of potential synergy between electromagnetic-resonance signaling and pharmacologic immune modulation.\n\nManufacturer \u002F Source:\n\nCompounded formulation supplied by Truway Health Clinical Pharmacy, New York, NY (cGMP-certified).\n\nRoute of Administration:\n\nOral (capsule)\n\nDosage Form:\n\nCapsule, 4.5 mg\n\nFrequency \u002F Duration:\n\nOnce daily for 12 weeks\n\nIntended Use:\n\nInvestigational immune-modulating therapy to complement non-pharmacologic intervention.",[50,51],[66],"Naltrexone Hydrochloride, 4.5 mg oral capsule",[68],{"measure":69,"description":70,"timeFrame":71},"Change in Autoimmune Flare Frequency","Number of clinically confirmed autoimmune flare events during the 6-month observation period compared to baseline, using validated disease-specific scoring systems (e.g., SLEDAI for lupus, DAS-28 for rheumatoid arthritis, or EDSS for multiple sclerosis).","Baseline to Month 6",[73],{"measure":74,"description":75,"timeFrame":76},"Cytokine Synchronization Index (CSI)","Change in cytokine synchronization index (CSI) calculated from multiplex cytokine panels (IL-6, TNF-α, IFN-γ, IL-10) using Fourier-transformed oscillatory coherence values between cytokine pairs.","Baseline, Week 12, and Month 6","ALL",null,false,{"inclusion":81,"exclusion":82,"raw_text":83},[],[],"Inclusion Criteria:\n\n1. Male or female participants aged 18-70 years.\n2. Clinical diagnosis of a systemic autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, or multiple sclerosis) confirmed for at least 12 months.\n3. Stable disease-modifying therapy or corticosteroid regimen for at least 8 weeks prior to enrollment.\n4. Willingness to maintain current medication schedule for the duration of the study.\n5. Ability to provide written informed consent and comply with study procedures.\n6. Access to stable internet or smartphone connection for digital consent verification and symptom tracking.\n\nExclusion Criteria:\n\n1. Presence of an implanted medical or electronic device (e.g., pacemaker, defibrillator, deep brain stimulator).\n2. Pregnancy or lactation.\n3. Active infection, malignancy, or significant hepatic, renal, or cardiovascular disease.\n4. Known photosensitivity, seizure disorder, or history of uncontrolled epilepsy.\n5. Prior participation in any electromagnetic or quantum resonance study within the past 6 months.\n6. Use of biologic or investigational therapy initiated within the previous 3 months.\n7. Inability to attend at least 80% of treatment sessions or follow-up visits.",[85,86,87],"CHILD","ADULT","OLDER_ADULT",[89],{"facility":90,"city":91,"state":91,"zip":92,"country":93,"geoPoint":94},"Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)","New York","10016","United States",{"lat":95,"lon":96},40.71427,-74.00597,[],[99],{"name":100,"affiliation":13,"role":101},"Gavin Solomon, President & CEO","PRINCIPAL_INVESTIGATOR",[],[104],{"label":105,"url":106},"Truway Health Official Website","https:\u002F\u002Fwww.truwayhealth.com",{"nct_id":4,"conditions":108,"biomarkers":110},[109,21,20,19],"Autoimmune Disease",[],{"nct_id":4,"found":79,"summary":78,"prompt_version":78}]