ImmuneNet: Quantum-Synaptic Immunotherapy Mapping
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Autoimmune Flare Frequency
研究概览
简要总结
The ImmuneNet study is a Phase I/II 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.
Participants 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.
A 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.
The 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.
详细描述
This exploratory, randomized, double-blind, parallel-assignment Phase I/II trial is designed to evaluate the safety, tolerability, and biological activity of low-frequency electromagnetic resonance (LF-EMR) for immune modulation.
Rationale 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.
Methods 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 (< 2 microtesla) for 20 minutes per session, three times weekly for twelve weeks. Sham participants will undergo identical procedures with the device inactive.
Blood 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.
Outcome 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind trial. Devices are pre-coded by an independent technician so that neither participants nor investigators can distinguish active from sham units. Outcomes assessors remain blinded until database lock.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18-70 years.
- •Clinical diagnosis of a systemic autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, or multiple sclerosis) confirmed for at least 12 months.
- •Stable disease-modifying therapy or corticosteroid regimen for at least 8 weeks prior to enrollment.
- •Willingness to maintain current medication schedule for the duration of the study.
- •Ability to provide written informed consent and comply with study procedures.
- •Access to stable internet or smartphone connection for digital consent verification and symptom tracking.
排除标准
- •Presence of an implanted medical or electronic device (e.g., pacemaker, defibrillator, deep brain stimulator).
- •Pregnancy or lactation.
- •Active infection, malignancy, or significant hepatic, renal, or cardiovascular disease.
- •Known photosensitivity, seizure disorder, or history of uncontrolled epilepsy.
- •Prior participation in any electromagnetic or quantum resonance study within the past 6 months.
- •Use of biologic or investigational therapy initiated within the previous 3 months.
- •Inability to attend at least 80% of treatment sessions or follow-up visits.
研究组 & 干预措施
Active Low-Frequency Electromagnetic Resonance (LF-EMR)
Participants in the experimental arm will receive non-invasive low-frequency electromagnetic resonance (LF-EMR) therapy three times per week for twelve weeks. Each session uses a calibrated emitter producing resonant fields between 7-40 Hz at amplitudes below 2 microtesla. The treatment is designed to promote synchronized signaling among immune effector cells and reduce autoimmune flare frequency.
干预措施: Low-Frequency Electromagnetic Resonance Therapy (LF-EMR) (Device)
Active Low-Frequency Electromagnetic Resonance (LF-EMR)
Participants in the experimental arm will receive non-invasive low-frequency electromagnetic resonance (LF-EMR) therapy three times per week for twelve weeks. Each session uses a calibrated emitter producing resonant fields between 7-40 Hz at amplitudes below 2 microtesla. The treatment is designed to promote synchronized signaling among immune effector cells and reduce autoimmune flare frequency.
干预措施: Sham Resonance Device (Inactive Control) (Device)
Active Low-Frequency Electromagnetic Resonance (LF-EMR)
Participants in the experimental arm will receive non-invasive low-frequency electromagnetic resonance (LF-EMR) therapy three times per week for twelve weeks. Each session uses a calibrated emitter producing resonant fields between 7-40 Hz at amplitudes below 2 microtesla. The treatment is designed to promote synchronized signaling among immune effector cells and reduce autoimmune flare frequency.
干预措施: Low-Dose Naltrexone (LDN) (Drug)
Sham Electromagnetic Stimulation (Placebo Control)
Participants in the control arm will undergo identical procedures with a deactivated (sham) LF-EMR device that emits no measurable electromagnetic field. This arm controls for placebo and procedural effects. Neither participants nor investigators will know which device is active or inactive.
干预措施: Low-Frequency Electromagnetic Resonance Therapy (LF-EMR) (Device)
Sham Electromagnetic Stimulation (Placebo Control)
Participants in the control arm will undergo identical procedures with a deactivated (sham) LF-EMR device that emits no measurable electromagnetic field. This arm controls for placebo and procedural effects. Neither participants nor investigators will know which device is active or inactive.
干预措施: Sham Resonance Device (Inactive Control) (Device)
Sham Electromagnetic Stimulation (Placebo Control)
Participants in the control arm will undergo identical procedures with a deactivated (sham) LF-EMR device that emits no measurable electromagnetic field. This arm controls for placebo and procedural effects. Neither participants nor investigators will know which device is active or inactive.
干预措施: Low-Dose Naltrexone (LDN) (Drug)
结局指标
主要结局
Change in Autoimmune Flare Frequency
时间窗: Baseline to Month 6
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).
次要结局
- Cytokine Synchronization Index (CSI)(Baseline, Week 12, and Month 6)