KALAYA PRODUCTS RESEARCH & DEVELOPMENT CONSORTIUM
Synapse Stimulating Device
Pain Relieving Stimulator - PRS
NEURO CHEMICAL NATURAL MEDICINE
“BIO-ELECTRICAL EXPERIMENT FOR PAIN MODULATION”
“Pain removing with a recording of an amplified musical note played through a simple MP3 player or an IPod sounds stupid.” The fact is that there is considerable high quality science backing this concept. The ‘frequency’ of 980 Hz found on a piano stimulates the resonance of a fit human, without any pain.
This digital audio-driven electrical stimulation technology now incorporated into the “PAIN REMOVING STIMULATOR” is quite amazing. The synaptic wave form is only the beginning of what will become electronic pharmacology. This non-invasive approach to alleviating symptoms of a variety of pain causing problems, and to reduce their occurrence, is highly desirable. The technology avoids the adverse side effects associated with ‘drug-therapy’, as well as dramatically reducing treatment costs.
Referred to as “NEUROMODULATION” this is a departure from conventional medicine and the aim is not to cure a disease or remove an abnormal structure, but to enhance normal function or to reduce dysfunction by modulating the chemical and electrical properties of the nervous system structures. This stimulation “kick-starts” the healing processors.
Cutting-edge scientists and clinicians believe that in the not-to-distant future electrical and/or chemical modulation will be the approach of choice. These non-invasive modalities have significant effects on many systems outside the nervous system. A large body of literature is already available on the treatment of chronic PAIN, movement disorders, intractable angina, peripheral vascular disease and treatments of viral conditions.
Any regulatory authority does not approve this “PAIN REMOVING STIMULATOR or PRS” device and we make no claims what so ever. It is experimental, but when we are hurting it only takes us a few minutes to stop the hurt and speed up the healing process. Gerald Hancock (2009)
Pain is the leading reason for seeking care from a physician and for taking medication. Pain has been described as the least understood of all human ailments, it is rarely considered to be a significant health problem in its own right, and as such is grossly under treated. Melzac (1990) stated that prolonged pain destroys the quality of life, can erode the will to live and at times drives people to suicide.
Severe pain can cause a host of medical complications, it slows recovery, makes breathing difficult and puts stress on the heart and circulatory system and there is evidence that it can suppress the immune system, which lowers the resistance to disease. When pain persists it can produce dramatic personality changes that can permanently alter family and work relationships.
Many scientists and clinicians believe that the current state of treating diseases with “Drugs and/or Surgery” will change in the not-to-far distant future to one where “Electrical and/or Chemical Neuromodulation (nerve regulation or adjustment) will be the future choice.
The Synapsis Stimulating Device (SSD) now known as the Pain Relieving Stimulator (PRS) is an Electronic Neuromodulator that is proving to be very effective in treating severe, acute and chronic pain problems. It is non-invasive and unlike drugs it has no untoward side effects. This device stimulates the electrical activity in the synapsis regions of the human nervous system with a very specific waveform that pulses at a rate of approximately 980 Hz. (Hertz).
The PRS device is a very simplified device that is based on the work of Dr. Leon M. Silverstone and Pahl Dickson. Dr. Silverstone invented the SEA-Technology Neuromodulator which he patented in 1990 and again (modified version) in 2002, His Synapsis Electronic Activation (SEA) device was approved by the FDA in 1997 for the treatment of pain at the cellular level.
Dr. Leon Silverstone
Synaptic (SEA) Machine Waveform (Patented)
A REPRODUCTION OF THE 980 Hz WAVE FORM
PRODUCED BY THE SSD
After sixteen years of clinical observations by physicians Dr. Silverstone’s SEA device has shown it can control pain and is also proving to have some beneficial effect with some degenerative conditions such as tremor of the hands and head as well as helping other debilitating diseases (Depression, Multiple Sclerosis). During this sixteen years of field testing there has never been a single safety complaint reported from over 1000 practitioners in the USA and elsewhere who have treated and validated the effectiveness of the Synapsis Stimulating Device (SSD) with over 250,000 patients.
Dr. Leon Silverstone invented the Synaptic machine (SEA) to stop pain. His creation turned out to do far more than to just provide analgesia. It generally ceases or reduces Parkinson’s tremor, relieves MS rigor, reverses myalgia, and dramatically elevates the production of depressed neurochemicals, speeds up the healing of traumatic injuries by 30% or more, wakes up numb nerve channels, eases addiction therapy, helps with ADD, autism, CP, and much more. In short his Synaptic technology has been recognized as the most effective “Therapeutic Neuromodulation” treatment currently available.
Pain Relieving Stimulator
THE SYNAPSIS STIMULATING DEVICE (SSD):
The SSD is a non-invasive electronic stimulating (medical) device that creates several unique actions, that encourages the brain to synthesis and releases the natural brain chemicals in a normal physiological manner. These ‘brain chemicals’ are essential for all quality of life events, such as sleeping adequately, not being depressed, not over eating and the ability to control pain and many other features. No drug can achieve this, in spite of the claims made by the drug manufactures. Drug manufactures claim that their antidepressants (Prozac family, SSRI’s) increase serotonin levels, which they do not – they confuse the neural system into believing the there is more neurochemicals available by preventing them the normal reuptake of unused neurochemicals (inhibiting endocytisis). This non-physiological approach has its own complications, one being the increased prevalence to suicidal thoughts.
The “PRD” is designed to produce tissue anesthesia (general loss of feeling, such as pain. heat, cold, touch and other less common varieties of sensation) non-invasively, without the use of needles or anesthetic fluids. Independent blood assays on subjects, before, during and after treatment with the “PRD” technology have shown increased levels of neurochemicals in whole blood samples such as serotonin, beta-endorphins, ACTH and others including, Epinephrine and Norepinephrine. Some of these Neurochemicals act as natural morphine-like agents to inhibit pain, while others raise the pain threshold in a natural manner. Studies have shown that the brain chemicals Serotonin, Beta-endorphins and ACTH levels have continued to change upwards for up to twenty four hours following a Synaptic Stimulation “PRD” treatment.
The positive effect of the neurochemical changes on patient pain levels seems to last up to 48 hours after treatment. Most patients report that after the “PRD” treatment a pattern of early profound tissue anesthesia, followed by analgesia (a remedy that removes or relieves pain), which can last up to 48 hours post treatment. Whereas initial short-term anesthesia is useful for treating pain, longer-term analgesia produces sensory suppression that can result in significant biological consequences. Therefore, analgesia is the essence of optional pain control. Clinical feedback from SSD technology produces early anesthetic followed by longer-term analgesia in 80% -85% of pain patients undergoing the prescribed SSD treatment. Furthermore, SSD treatment produces no known undesirable side effects.
Subjects experience “calmness” during and after treatment with the Synapsis Stimulating Device (SSD) because their serotonin levels were found to be elevated after a 20-minute treatment with the neuromodulator. Assays taken 24 hours after treatment showed that neurochemical levels continued to rise after treatment until they begin to reduce after 72 hours. After the initial treatment the baseline values of the neurochemicals continued to be cumulative with each additional treatment. Subjects continued to improve over time with respect to criteria such as pain control.
THE SYNAPTIC IMPULSE:
The healing waves of electricity tickle or tingle as they penetrate deeply into the nerves and this replaces the pain signals and encourages the healing processes. To quote Pahl Dickson commenting on the waveform of Dr. Silverstone, “The rise in positive charge primes and pushes the proper neurotransmitter chemicals across the synapses, and the complex curve on the backside of the waveform pulls the right chemicals back so as to fire again, 980 times a second”
Dr. Leon Silverstone’s Illustration showing the increase in neurochemicals before, during & after treatment
Notice how the pain relieving neurochemicals continue to build up long after the treatment has finished.
Dr. Leon Silverstone’s Illustration showing the increase in neurochemicals before and after treatment.
Blood assays of subjects utilizing SEA/SSD technology devices have demonstrated that these devices have the ability to modulate the levels of neurotransmitters in humans. Neurochemical assays taken from blood samples prior to treatment, at the end of a 20 minute treatment, and 24 hours after treatment, have demonstrated that neurotransmitters such as beta-endorphins, serotonin, ACTH, epinephrine, norepinephrine, and somatostatin are modulated during treatment and continue to be modulated for periods of at least 24 hours after treatment, relative to pre-treatment levels (Silverstone, 1996).
These results are unique to SEA/SSD technology and show that its use influences both the exocytosis and endocytosis cycles at the synapse. While some neurochemicals have a direct effect on pain perception, such as the endorphins, enkephalins, somatostatin and serotonin, others such as ACTH and serotonin influence mood and depression, which usually accompany chronic pain syndromes. Additionally, serotonin has the ability to elevate the pain threshold level so that previous noxious stimuli are no longer interpreted as painful.
Neuromodulation is a non-invasive approach to alleviating symptoms of pain that relies on the ability of the unique electrical signals to “activate” the almost limitless power of the human brain via neural pathways that are not always accessible to drug therapy.
NEUROTRANSMITTERS THAT PLAY KEY ROLES IN THE PAIN CYCLE:
Neurotransmitters are biochemicals produced by neurons which are responsible for the transmission of messages from the brain to the body’s billions of nerve cells. Some neurochemicals have a direct affect on pain perception, such as Endorphins, Enkepalins, Somatostatin and Serotonin. Others such as ACHT and Serotonin influence mood and depression, which usually accompany chronic pain syndromes. Additionally, Serotonin has the ability to elevate the pain threshold level so the previous noxious stimuli (harmful incitement) are no longer interpreted as painful.
Beta-Endorphins: Pain impulses are transmitted from the skin to the spinal cord via sensory nerve fibers, specifically A-delta and C-fibers. Beta-endorphins and Enkephalins are powerful natural opioids that combat pain as well as make the patient feel “good”. This feeling of elation is important in overcoming the depression that is almost always experienced by patients with chronic pain. These neurochemicals are produced in the Periaqueductal Gray (PAG) of the midbrain (see Fig. 6) as part of the Descending Inhibitory Pathways (DIP).
Serotonin: Reduced levels of this important neurotransmitter play significant roles in producing symptoms of depression, lowering pain threshold levels, reducing quality of sleep time, and increasing appetite and erratic behavior. This neurochemical also plays significant roles in both vasodilation and vasoconstriction of blood vessels. Serotonin is produced in the Nucleus Raphe Magnus (NRM) located in the brain stem as part of the DIP (see Fig. 6).
ACTH: Stress and/or depression affects the hypothalamus in the brain, resulting in the production of Cortico Producing Tropic Hormone (CPH), which affects the pituitary gland and plays a key role in the synthesis of ACTH. ACTH activates the adrenal glands to produce cortisol, which together with epinephrine constitutes the body's “fight or flight” hormonal response.
GABA: A substantial body of evidence suggests a significant role for the inhibitory neurotransmitter GABA (gamma aminobutyric acid) in modulation of nociception. Systemic administration of GABAA receptor agonists such as THIP and muscimol has been to inhibit responses to noxious stimulation. However, GABA is distributed throughout the nervous system and participates in a wide variety of neural circuits, including systems crucial to both transmission and modulation of nociception.
PRS TECHNOLOGY RESULTS IN ELECTRICAL IMPULSES TRAVELLING ALONG SPECIFIC SENSORY NERVE PATHWAYS
(TO ACHIEVE FOUR MAIN OBJECTIVES)
1. Significantly inhibit chronic pain by blocking pain signals to the brain via Ascending Pain Pathways.
2. Stimulate Descending Inhibitory Pathways from Higher Brain Centers to the Midbrain and Brainstem to produce brain chemicals, levels of which can be assayed from whole blood.
3. Increase the level of healing of tissues by elevation of brain chemicals in a “natural” manner, far more effectively than with the use of drugs, and without the adverse side effects associated with medications.
4. Produce near-term issue Anesthesia and longer-term Analgesia for treated tissue. In many cases this can eliminate the need for invasive procedures such as injection of local anesthetic by needle.
PAIN & INHIBITORY PATHWAYS (SIMPLIFIED)
ASCENDING PAIN CREATING PATHWAYS
Pain impulses from free nerve endings (nociceptors) in skin and other tissues are conducted along the A delta (sharp pain) and C fibers (prolong burning pain).
These First Order Neurons (FON’s) enter the dorsal horn of the spinal cord and synapse with Second Order Neurons (SON’s).
SON’s then cross the spinal cord and join with the Lateral Spinothalamic Tract (LST), which carries pain impulses up the spinal cord into the brain stem, midbrain and thalamus.
The LST then synapses with Third Order Neurons (TON’s), which ascend to the cerebral cortex.
The brain stem and thalamus are responsible for pain perception whereas the cerebral cortex gives pain location and pain intensity.
DESCENDING INHIBITORY PATHWAYS (DIP)
The DIP begins in the cerebral cortex and descends to the thalamus and then to the Periaqueductal Gray (PAG) of the midbrain. The PAG is an important region since it is rich in opiate receptors responsible for secreting morphine-like enkephalins and endorphins. Fibers from the PAG then descend to another very important region of the DIP, the Nucleus Raphe Magnus (NRM) located in the brainstem. The NRM is responsible for the secretion of serotonin, which plays important roles in elevating pain threshold levels and combating depression.
Fibers descend from the NRM and enter the spinal cord, exciting other inhibitory interneurons to secrete additional powerful anti-pain neurotransmitters such as gamma-aminobutyric acid (GABA). These lower fibers of the DIP synapse with interneurons that communicate with pain signals entering the spinal cord via A delta and C fibers, as well as with the SON’s of the Lateral Spinothalamic Tract (LST). This demonstrates that the DIP act at all levels from the higher brain centers down to the dorsal horn region of the spinal cord where pain signals first enter the central nervous system.
In addition to control of pain and depression, quality of sleep time, reduce appetite and erratic neurotransmitters also enhance tissue healing, increase behavior, and generally increase the quality of life.
CONVENTIONAL ELECTROTHERAPY DEVICES (CED’s)
Electrical treatment devices include many different technologies and date back to the 1940’s in Europe. In order to provide some semblance of order into this disorganized field, this author has categorized devices into four specific groups. These groups will collectively be referred to as “Conventional Electrotherapy Devices”.
1. Transcutaneous Electrical Nerve Stimulation (TENS). Transcutaneous electrical nerve stimulation is known by the acronym TENS and was developed in the 1960’s, based on the work of Melzack and Wall (1965). They have been used exclusively for pain relief and are most commonly small box-like units worn by patients for many hours each day, often referred to as belt-TENS. They have not changed much in appearance or output since they were first introduced. Although used a great deal in the 1960’s and 1970’s, results have been less impressive over the past two decades and as a result, TENS is of more limited use today. Originally they were not designed for pain rulate damaged nerves and muscles. Typical Output: 1-180 Hz frequency; 30-100 volts; 30-75 mA.
2. Micro Current Electrical Neuromuscular Stimulation (MENS) Micro-current technology uses sub-sensory currents; patients therefore have no sensation of the treatment. Developed in the early 1970’s, this was based on the belief that human cells can only function at micro-levels (µm), not mille-levels (m) of current (1000µm = 1m). However, contrary to this assumption, the human nerve cell has a resting voltage gradient of -70 millivolts and during firing, increases to 100 millivolts in amplitude. Typical Output: 10 - 600 µA; 0.1 - 990 Hz frequency. A frequency range of 1 - 10 Hz is recommended for reducing swelling. The recommended frequency range for pain relief is 80 - 150 Hz, comparable to that used with TENS.
3. Electrical Neuromuscular Stimulation (EMS) These devices were developed in the 1950’s and are used for relaxation of muscle spasms. They are not cleared for pain control by the FDA since this claim is limited to the TENS category, in spite of pain claims by devices in this category. This family of devices has not changed much over the past three decades and numerous models are marketed. Typical Output: 1-120 Hz frequency; 35-200 Volts; 35-125 mA.
4. Interferential Therapy. Interferential current is another type of EMS therapy produced by crossing two medium frequency currents of 4000 Hz and 4100 Hz, which cancel out, leaving standard low frequency stimulation current. The frequency can be altered within the range of 1-150 Hz, little different from the other modalities described above. Although some practitioners in the U.S. regard interferential therapy as being fairly recent technology, it was in fact patented in Europe in the late 1940’s, although only introduced into the USA during the 1970’s.
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KALAYA PRODUCTS RESEARCH & DEVELOPMENT CONSORTIUM