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Enrolling by invitation Phase 1/2

Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)

NCT07221565 · tracked via the Priya Life Science USA tracker
Phase
Phase 1/2
Started
2025-10-23
Last updated
2026-05-22

Condition(s) studied

Systemic Lupus ErythematosusRheumatoid ArthritisMultiple SclerosisAutoimmune DiseasesChronic Inflammatory SyndromesImmune Dysregulation

Investigational drug(s) / intervention(s)

Low-Frequency Electromagnetic Resonance Therapy (LF-EMR)Sham Resonance Device (Inactive Control)Low-Dose Naltrexone (LDN) →

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.

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.

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 electromagnetic-resonance signaling and pharmacologic immune modulation. Manufacturer / Source: Compounded formulation supplied by Truway Health Clinical Pharmacy, New York, NY (cGMP-certified). Route of Administration: Oral (capsule) Dosage Form: Capsule, 4.5 mg Frequency / Duration: Once daily for 12 weeks Intended Use: Investigational immune-modulating therapy to complement non-pharmacologic intervention.

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male or female participants aged 18-70 years. 2. Clinical diagnosis of a systemic autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, or multiple sclerosis) confirmed for at least 12 months. 3. Stable disease-modifying therapy or corticosteroid regimen for at least 8 weeks prior to enrollment. 4. Willingness to maintain current medication schedule for the duration of the study. 5. Ability to provide written informed consent and comply with study procedures. 6. Access to stable internet or smartphone connection for digital consent verification and symptom tracking. Exclusion Criteria: 1. Presence of an implanted medical or electronic device (e.g., pacemaker, defibrillator, deep brain stimulator). 2. Pregnancy or lactation. 3. Active infection, malignancy, or significant hepatic, renal, or cardiovascular disease. 4. Known photosensitivity, seizure disorder, or history of uncontrolled epilepsy. 5. Prior participation in any electromagnetic or quantum resonance study within the past 6 months. 6. Use of biologic or investigational therapy initiated within the previous 3 months. 7. Inability to attend at least 80% of treatment sessions or follow-up visits.

Primary outcome measure(s)

  • Change in Autoimmune Flare Frequency — 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).

Trial sites (1)

FacilityCityRegionStatus
Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016) New York New York
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221565 on ClinicalTrials.gov ↗ ← All trials in the USA