Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)

Part of paid clinical trials in New York, New York.

Sponsor
Truway Health, Inc.
Study ID
NCT07221565
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low-Frequency Electromagnetic Resonance Therapy (LF-EMR) — DEVICE
    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) — DEVICE
    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) — DRUG
    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 Details

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.

Key Dates

Start date
Oct 23, 2025
Status verified
May 2026
Primary completion
Oct 23, 2034
Completion
Oct 23, 2034

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)New YorkNew York10016-

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By condition
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By specialty
NeurologyBrain disordersAutoimmune diseaseRheumatologyMusculoskeletal disorders
By research site
Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)· New York, NY

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