Combinatorial methods for disease therapy

Abstract

A method of providing therapy for a medical condition or symptom in a subject. The method includes performing a cardiovascular metabolic assessment test on a subject having a medical condition prior to and after applying therapy with one or more of biomagnetic therapy, biothermodynamics therapy, and neurolinguistic programming. The method optionally includes performing an electroencephalogram prior to and after the treatment.

Description

[0001] PATENT APPLICATION

[0002] Attorney Docket No. BYWU-OOl-WOl

[0003] COMBINATORIAL METHODS FOR DISEASE THERAPY

[0004] RELATED APPLICATION

[0005] This application claims the benefit of US Provisional Application Serial No. 63 / 728,825 filed on December 6, 2024. The entire teachings of the above application is incorporated herein by reference.

[0006] BACKGROUND

[0007] Integrative Medicine makes use of conventional medicine and complementary medicine approaches in a coordinated fashion. It is an approach to healthcare that includes practices not traditionally part of conventional medicine, for example, herbs and supplements, wellness coaching, meditation, massage, movement, resiliency, acupuncture, and nutrition.

[0008] Integrative Medicine emphasizes interventions in which conventional health care approaches are combined with complementary health approaches with an emphasis on treating the whole person rather than, for example, one organ system.

[0009] Integrative Medicine approaches can be used to help individuals with medical conditions improve by reducing fatigue, nausea, pain, and anxiety. Such medical conditions include, among others, cancer, chronic fatigue, chronic pain, fibromyalgia, and diabetes.

[0010] The need exists to develop combination therapies for medical conditions that include non-traditional but scientifically valid approaches.

[0011] SUMMARY

[0012] To meet the need set forth above, a method is disclosed for providing therapy for a medical condition or symptom in a subject. The method is accomplished by (i) performing a cardiovascular metabolic assessment test (CMAT) on a subject having a medical condition; (ii) optionally, performing a first electroencephalogram (EEG) of the subject prior to treatment; (iii) applying to the subject one or more therapies selected from biomagnetic therapy, biothermodynamics therapy, and Docket No. BYWU-OOl-WOl

[0013] -2- neurolinguistic programming; (iv) performing a second CMAT and, optionally, a second EEG to monitor effectiveness of the one or more therapies; and (v) examining the subject clinically to assess the medical condition or symptom.

[0014] The details of one or more embodiments of the invention are set forth in the drawings and description below. Other features, objects, and advantages of the invention will be apparent from the description, from the drawings, and from the appended claims.

[0015] BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The foregoing and other objects, features and advantages will be apparent from the following description of particular embodiments of the disclosure, as illustrated in the accompanying drawings.

[0017] FIG. 1A shows a summary of a cardiovascular metabolic assessment test (CMAT) performed on a 33-year-old male subject prior to therapy with the Trio protocol;

[0018] FIG. IB shows a summary of a CMAT performed one week after therapy;

[0019] FIG. 2A shows an EEG recording of the subject prior to therapy;

[0020] FIG. 2B shows an EEG recording of the subject three weeks post-therapy;

[0021] FIG. 3A shows a summary of a CMAT performed on an 88-year-old female subject prior to therapy;

[0022] FIG 3B shows a summary of a CMAT performed 5 days after therapy with the Trio protocol;

[0023] FIG. 4A shows an EEG recording of the subject prior to therapy;

[0024] FIG. 4B shows an EEG recording of the subject 4 days post-therapy;

[0025] FIG. 5A shows an EEG recording of a 57-year-old female subject prior to biomagnetic therapy; and

[0026] FIG. 5B shows an EEG recording of the subject immediately after 30 minutes of biomagnetic therapy.

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[0029] DETAILED DESCRIPTION

[0030] As described above, a method is disclosed to provide therapy for a medical condition or symptom. The method includes a step of applying to the subject one or more therapies, i.e., biomagnetic therapy, biothermodynamics therapy, and neurolinguistic programming.

[0031] Biomagnetic therapy is an approach that restores the body’s homeostasis. This therapy is non-invasive, inherently safe, and rooted in the principles of biophysics. Changes in pH levels of internal organs can cause numerous ailments and psychological dysfunctions. Balanced pH levels in organs or physical systems can prevent illness. Biomagnetic therapy re-establishes the acidic-alkaline balance in organs or physical systems by shifting hydrogen ion concentrations, allowing the body to heal itself.

[0032] Biomagnetic therapy can be carried out by applying one or more pairs of permanent magnets to a surface, e.g., skin, of the subject. The entire body can be systematically scanned, e.g., using Applied Kinesiology testing, by posing targeted questions regarding specific organs or tissues. For instance, an issue with the pituitary gland will manifest as hand, leg, or finger shortening, confirming the presence of an abnormality. It is crucial to identify corresponding biomagnetic pairs for effective therapy.

[0033] The permanent magnets can be, but are not limited to, neodymium magnets having a strength of 1,000 Gauss to 15,000 Gauss, i.e., 0.1 Tesla to 1.5 Tesla. The magnets can be contained within a sleeve, e.g., leather, and, as such, are not applied directly to the skin. In specific embodiments, the magnets are contained within a face mask, a knee brace, or a wrapping fabric.

[0034] As an alternative or as a supplement to the therapy described in the preceding two paragraphs, biomagnetic therapy can be achieved by affixing a biomagnetic cap to the head of a subject for a period of 30 min. to 7 h daily. The magnetic cap can include 2 to 10 pairs of permanent magnets, e.g., neodymium magnets. The strength of the permanent magnets can be 1,000 to 15,000 Gauss. A particular biomagnetic cap includes 8 to 10 N52 neodymium magnets of 14,400 Gauss with positive and negative polarities placed at locations corresponding to the frontal, temporal, parietal, and occipital lobes.

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[0037] In another embodiment, biomagnetic therapy is accomplished by applying repetitive transcranial magnetic stimulation (“rTMS”). rTMS therapy can be applied for a period of from 3 to 40 minutes. In another embodiment, the rTMS is applied on five days per week for 4 to 6 weeks. The subject to which rTMS is applied can suffer from one or more of treatment-resistant depression, obsessive-compulsive disorder, migraines, anxiety with depression, and smoking dependence.

[0038] The rTMS can also be carried out by holding an electromagnetic coil against the head near an area of the brain thought to be involved in mood regulation, cognitive control, or both. These brain areas include the left prefrontal cortex (for depression) and the dorsomedial prefrontal cortex or anterior cingulate cortex (for OCD). In deep TMS, two coils may be used to deliver more stimulation to the region and target larger structures deep in the brain. Short electromagnetic pulses are repeatedly administered at 10 HZ to 20 Hz through the coil or coils.

[0039] Biothermodynamics provides insight into the healing potential of metabolism. Biological systems, as open systems, dissipate energy to maintain structure and function, ensuring cellular processes remain efficient. This energy dissipation is crucial for homeostasis and repair mechanisms. For example, studies have shown that heat generated during cellular respiration not only drives ATP production but also plays a role in protein folding and repair, highlighting how thermodynamic principles underlie both energy metabolism and healing processes. Understanding the intricate connection between thermodynamics, metabolism, and cellular function is key to exploring new therapeutic approaches that harness the body's natural energy flows for healing.

[0040] Biothermodynamics therapy, as employed in the method set forth herein, is carried out by scanning a plurality of anatomical points associated with biological systems of the subject to determine a subset of the plurality of biological systems that are functioning sub optimally and stimulating the subset of biological systems to optimize their function.

[0041] Scanning, i.e., by applied kinesiology, is accomplished by questioning the subject regarding the functioning of each of the plurality of biological systems and recording a response of the subject to the questioning. The response of the subject can be determined by kinesiology, e.g., movement or lengthening of a specific muscle. A positive response to a question for a specific biological system indicates

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[0043] -5- that the biological system is functioning sub optimally. In certain methods, the questioning is directed to a biological system that comprises several subsystems. For example, the subject can be questioned regarding functioning of the arteries.

[0044] Recording a positive response of the subject can be followed by further questioning regarding the function of specific arteries. The questioning can be directed at as many as 800 (e.g., 100, 200, 300, 400, 500, 600, 700, and 800) anatomical points.

[0045] In the method, stimulating the biological system that is functioning sub optimally can be carried out by issuing verbal commands to the subject to optimize that biological system.

[0046] The therapeutic method emphasizes a personalized approach. After a thorough scanning process, the specific frequencies and treatment schedules are made unique to each individual patient, ensuring a bespoke therapy plan.

[0047] Neurolinguistic programming, a form of which is known as the Yuen Method, is one of many energy psychology techniques and is a powerful non-touch technique blending anatomy, physiology, applied kinesiology, structural analysis, energetic technique, and quantum physics, to quickly locate and shift one’s imbalances / blocks on all levels and dimensions. When weak energy signals in the body are identified and optimized, one experiences relief from physical pain (relief can sometimes be immediate), emotional issues, old behavior patterns, and more. It can greatly minimize or totally eliminate chronic and painful conditions and can often deliver prompt results on the spot or even at a distance.

[0048] As employed in the method, neurolinguistic programming can be carried out by determining imbalances within biological systems of the subject and identifying the underlying emotional states contributing to the disequilibrium. Once imbalances are identified, specific verbal commands are directed to the subject, thereby stimulating the body to initiate the necessary physiological adjustments to return to equilibrium.

[0049] For example, a psychological trauma can be associated with a specific condition, e.g., pain, and addressing the psychological trauma can relieve the pain.

[0050] In one specific method, biomagnetic therapy, biothermodynamics therapy, and neurolinguistic programming are applied to the subject for a period of 30 min. to 90 min.

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[0052] -6-

[0053] The method also includes a step of performing a cardiovascular metabolic assessment test (CMAT). The CMAT includes a number of tests that evaluate systemic and peripheral circulation, as well as sympathetic and parasympathetic nervous system responses. For example, ankle-brachial pressure index (ABPI) and ankle-brachial index (AB I) can be calculated, and pulse volume recording (PVR) / volume plethysmography can be performed. The blood pressure (“BP”) can be measured at the upper and lower extremities simultaneously to calculate the ABI. In another example, a toe sensor can assess the dorsalis pedis arteries and calculate toe brachial index. The volume plethysmography analysis at the arm provides the peripheral Augmentation index (pAIx), which is a marker of aortic stiffness and allows for the calculation of Central Aortic Systolic Pressure (CASP). Further, the volume plethysmography analysis at the arm and ankles provides the brachial ankle Pulse Wave Velocity (baPWV) which is a marker of lower extremity artery stiffness.

[0054] The CMAT can be used to determine the need for medication in conjunction with the therapies.

[0055] The method can also include a second CMAT performed after applying the therapies to monitor the progress of the treatment. The second CMAT can also be used to determine whether medication dosages need to be adjusted, for example, increased, decreased, or ceased. In an embodiment, the second CMAT is performed within 1 week after the treating step.

[0056] The method optionally includes performing a first electroencephalogram (EEG) of the subject prior to therapy. Performing an EEG can be achieved by any method known in the art. A treating physician would know whether to perform the EEG, depending on the initial diagnosis. The EEG can be used to establish a baseline prior to therapy so that the effectiveness of the method can be monitored. The EEG can also be used to determine the need for medication in conjunction with the therapies.

[0057] The first EEG can also be used, but is not required, for identifying a focus for applying the biomagnetic and biothermodynamics therapies. For example, if the EEG shows a left frontal abnormal focus, the therapies can be focused to that area of the brain.

[0058] Also, as an option, a second EEG can be performed on the subject following the therapies discussed, infra. The second EEG is performed if the first EEG is

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[0060] -7- determined to be abnormal. In a particular method, the second EEG is performed within one week after the therapies are applied. In an embodiment, if the first EEG is severely abnormal and does not improve after therapy, as evaluated by the second EEG, additional therapies with more focus on the brain can be applied.

[0061] The method also includes a step of examining the subject clinically to assess the medical condition or symptom. This step is for monitoring the progress of the therapy.

[0062] The subject who will benefit from the above-described method can have, but is not limited to, one or more of the following medical conditions or symptoms: TMJ disorders, insomnia, syncope / dizziness, dysregulated reproductive hormones, tinnitus, unclarity of mind, Alzheimer's Disease, lack of alertness, memory deficit, numbness of fingers or toes (neuropathy), teeth grinding, excessive sensitivity to light, epilepsy, inflammation of the brain, optic neuritis, viral infection, blurred vision, eye fatigue, compromised microcirculation of the brain, hair loss, high blood pressure, drug addiction, emphysema, bipolar disorder, dental problems, depression, dysregulation of the lymphatic system, obsessive compulsive disorder, edema in the limbs, schizophrenia, skin rash, eczema, psoriasis, anxiety, muscles pain and soreness, panic attacks, chronic fatigue, pineal body dysfunction, joint pain and arthritis, vitiligo, intoxification, anemia, ptosis, speech issues, facial paralysis, melatonin dysregulation, and dysregulation of cranial nerve function.

[0063] The above approach aims to improve systemic function through enhanced blood flow (circulation), decreased bodily inflammation, maintenance of optimal cellular pH levels, increased vitality (energy), and reduced feelings of unease or worry (anxiety).

[0064] This therapy is relevant for various medical conditions, including autoimmune diseases, chronic pain, insomnia, anxiety, and diabetes, among others.

[0065] Without further elaboration, it is believed that one skilled in the art can, based on the disclosure herein, utilize the present disclosure to its fullest extent. The specific examples shown below are, therefore, to be construed as merely descriptive, and not limitative of the remainder of the disclosure in any way whatsoever. All publications and patent documents cited herein are incorporated by reference in their entirety.

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[0067] -8-

[0068] EXAMPLES

[0069] Example 1: Epilepsy, ADHD, Agitation, Chronic pain

[0070] A 33-year-old man had a history of frontal lobe epilepsy, Asperger’s syndrome, ADHD, episodic agitation, multiple joint pain (especially back pain), and insomnia. He was taking 28 types of prescribed or over-the-counter medications for epilepsy and mental health issues. At times, he had aggressive behavior toward his health aide during his anger outbursts.

[0071] He received 30 minutes of biomagnetism therapy (Trio protocol: biomagnetism, biothermodynamics, and neurolinguistic programming) on 9 / 17 / 2024. Immediately after the therapy, the patient had significantly improved range of motion in all 4 of his extremities. Back pain lessened from 8 / 10 to 0. He had improved alignment of his spine and was able to stand straight. He stated during the video recording: “ I feel at least 20 years younger. I feel great!” He reported to his neurologist 5 weeks later that he felt himself improved every day and it still had not reached a plateau yet. His irritable mood and grumpiness were still present during the first week after the therapy but resolved later.

[0072] Cardiometabolic assessment test (“CMAT”) was evaluated before therapy on 9 / 17 / 2024 when the CMAT score was 73% (see FIG. 1A), and one week after therapy on September 24, 2024, the score improved to 89% (see FIG. IB).

[0073] An EEG obtained on August 21, 2024, prior to the start of therapy, showed frequent L frontocentral sharp waves. See FIG. 2A. A follow-up EEG obtained on October 7, 2024 (after therapy) showed no epileptiform activity and only intermittent frontal slowing, representing a 90% improvement. See FIG. 2B.

[0074] Example 2: Dizziness, Cognitive seizure disorder, and Insomnia

[0075] An 88-year-old female patient presented with cognitive seizure disorder, severe cardiac autonomic dysfunction (dizziness, orthostatic hypotension), and insomnia. She requires a cane for ambulation and reported to her daughter blackout episodes with postural changes. Despite active exercise (walking daily, outdoor), she had severe microcirculation impairment and moderate-to-severe small fiber neuropathy and severe endothelial dysfunction. Her initial CMAT study did not include cardiac autonomic function session as she could not tolerate the test. Therefore, the pre-therapy score of 44% (see FIG. 3A) was over-estimated. The true

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[0077] -9- score was very likely below 40%, indicating high risk for stroke or heart attack. She received a 90-minute therapy session (Trio protocol) on 8 / 01 / 2024.

[0078] Post-therapy CMAT (8 / 06 / 2024) showed a score of 68% (see FIG. 3B), significantly improved microcirculation, small fiber neuropathy, cardiac autonomic function, hypertension, and endothelial function.

[0079] Immediate response after the therapy: She no longer complained about dizziness and no longer required a cane for ambulation. She kept alert during a 40-minute car ride and did not doze off. She appears to be 8-10 years younger. Her insomnia has significantly improved.

[0080] An EEG obtained on July 11, 2024, prior to therapy, showed a pattern of deep sleep with arousal. See FIG. 4A. A two-hour EEG recorded on August 5, 2024 (after therapy) showed light sleep. See FIG. 4B.

[0081] Example 3: Post-concussion memory decline, Headaches, Dizziness and Insomnia

[0082] A 57-year-old female patient had a minor head injury from a non-fault motor vehicle accident in April 2023. She developed frequent headaches immediately from a small subdural hemorrhage at the frontoparietal convexity. Episodic dizziness, visual disturbances and insomnia were improved after starting antiepileptic medications for post-traumatic simple partial seizure disorder. However, she was diagnosed with cognitive decline a few months after the head injury.

[0083] She received biomagnetism therapy as below:

[0084] 1) 30-minute biomagnetism therapy during a 2-hour video EEG monitoring on 8 / 20 / 2024. The EEG prior to initiation of therapy showed frequent sharply contoured waves at the left anterior head region (fronto-temporo-parietal). See FIG. 5 A. After therapy, the EEG showed improvement. See FIG. 5B.

[0085] 2) Home maintenance therapy with biomagnetism hat, daily 30 minutes or more since 8 / 30 / 2024

[0086] 3) Trio therapy (biomagnetism, biothermodynamics, and neurolinguistic programming) on 10 / 12 / 2024.

[0087] Clinically, she has been active in exercise and slept better.

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[0090] Example 4. Severe arthritis pain, status post knee surgery

[0091] A female patient suffered from severe knee pain due to arthritis and due to surgeries for broken bones. Her knee was treated with biomagnetic therapy for 15 minutes. She reported a significant reduction in knee pain post-therapy.

[0092] OTHER EMBODIMENTS

[0093] All of the features disclosed in this specification may be combined in any combination. Each feature disclosed in this specification may be replaced by an alternative feature serving the same, equivalent, or similar purpose. Thus, unless expressly stated otherwise, each feature disclosed is only an example of a generic series of equivalent or similar features.

[0094] From the above description, one skilled in the art can easily ascertain the essential characteristics of the present invention, and without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions. Thus, other embodiments are also within the scope of the following claims.

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Claims

Docket No. BYWU-OOl-WOlCLAIMS1. A method of providing therapy for a medical condition or symptom in a subject, the method comprising: performing a first cardiovascular metabolic assessment test (CM AT) on a subject having a medical condition prior to applying therapy; optionally performing a first electroencephalogram (EEG) of the subject prior to applying therapy; applying to the subject one or more therapies selected from the group consisting of biomagnetic therapy, biothermodynamics therapy, and neurolinguistic programming; performing a second CMAT and, optionally, performing a second EEG to monitor effectiveness of the one or more therapies; and examining the subject clinically to assess the medical condition or symptom.

2. The method of claim 1, wherein the CMAT includes measuring an ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) and pulse volume recording (PVR) / volume plethysmography.

3. The method of claim 1, wherein the second EEG is performed if the first EEG is abnormal.

4. The method of claim 1, wherein the second CMAT and the second EEG are performed within 1 week after the treating step.

5. The method of claim 1, wherein the one or more therapies are applied for a period of 30 min to 90 min.

6. The method of claim 1, wherein the examining step is carried out 1 to 4 weeks after the applying step.

7. The method of claim 1, wherein the medical condition or symptom is selected from the group consisting of TMJ disorders, insomnia, syncope / dizziness, dysregulated reproductive hormones, tinnitus, unclarity of mind, Alzheimer's Disease,Docket No. BYWU-001-W01-12- lack of alertness, memory deficit, numbness of fingers or toes (neuropathy), teeth grinding, excessive sensitivity to light, epilepsy, inflammation of the brain, optic neuritis, viral infection, blurred vision, eye fatigue, compromised microcirculation of the brain, hair loss, high blood pressure, drug addiction, emphysema, bipolar disorder, dental problems, depression, dysregulation of the lymphatic system, obsessive compulsive disorder, edema in the limbs, schizophrenia, skin rash, eczema, psoriasis, anxiety, muscles pain and soreness, panic attacks, chronic fatigue, pineal body dysfunction, joint pain and arthritis, vitiligo, intoxification, anemia, ptosis, speech issues, facial paralysis, melatonin dysregulation , and dysregulation of cranial nerve function.

8. The method of any one of claims 1-7, wherein only biomagnetic therapy is applied to the subject.

9. The method of claim 8, wherein the biomagnetic therapy is applied by placing pairs of permanent magnets on an outer surface of the subject, each of the permanent magnets being neodymium magnets having a strength of 0.1 Tesla to1.5 Tesla.

10. The method of claim 8, wherein the biomagnetic therapy includes affixing a biomagnetic cap to a head of the subject.

11. The method of any one of claims 1-7, wherein biomagnetic therapy, biothermodynamics therapy, and neurolinguistic programming are applied to the subject.

12. The method of any one of claims 1-7, wherein the biothermodynamics therapy comprises scanning a plurality of biological systems of the subject to determine a subset of the plurality of biological systems that are functioning sub optimally and stimulating the subset of biological systems to optimize function.4937-0568-6910, v. 1Docket No. BYWU-OOl-WOl-13-13. The method of any one of claims 1-7, wherein the neurolinguistic programming comprises determining a biological system of the subject that is in disequilibrium, identifying an emotional state of the subject associated with the disequilibrium, and stimulating the subject to restore equilibrium to the biological system.4937-0568-6910, v. 1

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