Quantum-Synaptic Immunotherapy Mapping Using Low-Frequency Electromagnetic Resonance and Machine Learning-Based Cytokine Forecasting
QSIT
ImmuneNet: Quantum-Synaptic Immunotherapy Mapping
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2025
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2025
CompletedStudy Start
First participant enrolled
October 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 23, 2034
October 29, 2025
October 1, 2025
9 years
October 23, 2025
October 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Cytokine Synchronization Index (CSI)
Baseline, Week 12, and Month 6
Study Arms (2)
Active Low-Frequency Electromagnetic Resonance (LF-EMR)
EXPERIMENTALParticipants 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 Electromagnetic Stimulation (Placebo Control)
SHAM COMPARATORParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Truway Health, Inc. www.truwayhealth.com (401 E 34th Street, S11P, New York, NY 10016)
New York, New York, 10016, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gavin Solomon, President & CEO
Truway Health, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2025
First Posted
October 28, 2025
Study Start
October 23, 2025
Primary Completion (Estimated)
October 23, 2034
Study Completion (Estimated)
October 23, 2034
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 12 months post-study completion
- Access Criteria
- Proposal review by Truway Health Data Access Committee; data-sharing agreement required
De-identified individual participant data (IPD) will be made available for secondary research analyses following publication of primary results. Shared data will include participant-level demographics, clinical outcomes, cytokine panels, and RNA sequencing results. Data will be accessible via the Truway Health ClinicalChain Data Repository, a blockchain-secured storage and access system ensuring traceable data integrity and compliance with HIPAA and GDPR standards. Access requests may be submitted to Truway Health, Inc. (help@truwayhealth.com) and will be reviewed by the sponsor's Data Access Committee. Researchers must provide a data use proposal and agree to a data-sharing agreement. IPD will become available approximately 12 months after study completion and remain available for a minimum of 5 years following initial publication.