Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)

Official title

ImmuneNet: Quantum-Synaptic Immunotherapy Mapping

Overview

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.

Detailed description

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.

Ethics 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.

Expected 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.

Interventions

• Device Low-Frequency Electromagnetic Resonance Therapy (LF-EMR)
  A non-invasive medical device that generates low-frequency electromagnetic fields (7-40 Hz \< 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.
• Device 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.
• 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. Low-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. This arm will allow assessment of potential synergy between electr

Primary outcome measures

• Change in Autoimmune Flare Frequency [Time frame: Baseline to Month 6]

Secondary outcome measures (1)

• Cytokine Synchronization Index (CSI) [Time frame: Baseline, Week 12, and Month 6]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016) — New York

Identifiers

NCT: NCT07221565 · TWH-QSIT-IMMUNENET-2025-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗