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Theory of Mechanism of Operation (Part 3/3) Application of the Resonator™ device in Parkinson’s disease is distinguished from other approved and accepted techniques in that it is entirely non-invasive. While DBS is a valuable treatment that is both FDA approved and CMS reimbursed, there is no consensus as to its mechanism of action. Additionally, there are important risks with DBS including intracranial hemorrhage, superficial and deep tissue infection as well as damage induced to surrounding neural tissue which occurs while implanting the electrodes. Ancillary costs for the technique are high. The electrodes must be implanted in a surgical suite, requiring a stereotactic fixator and the services of a neurosurgeon to do so. Further, in contrast to the application of the Resonator™ device, DBS yields its effects for as long as the stimulator is applying signal, with its’ effects ceasing as soon as the device is switched off. Patients report and we have observed beneficial effects lasting two months after intervention with the Resonator™ device. A critical issue is that of choosing the target molecule upon which the applied field strength and frequency is determined. Based on calculations derived from the Jacobson Resonance™ equation, it can be seen that it is the molecular weight of the target molecule that is the critical variable in the equation. As it is the loss of dopaminergic neurons and glial tissue in the substantia nigra that appear to be the initiating event in the development of Parkinson’s, the family of Nerve Growth Factors (brain derived neurotrophic factor, neurturin, glial derived neurotrophic factor) were chosen as the target molecules for the derived fields and frequencies in the treatment of Parkinson’s Disease. These compounds have been and continue to be extensively studied. Observations suggest that they have a wide variety of effects in the nervous system including both potentiation and depression of neuronal activity, promotion of synaptic plasticity, regulation of neuronal excitability, and promotion either of neuronal survival or apoptosis. The pharmaceutical industry has these and other neurotrophic factors under intensive scrutiny as targets for drug development in the treatment of Parkinson’s Disease. While we cannot at this time state with certainty that Jacobson Resonance™ does in fact specifically affect these active target molecules, further work with in vivo magnetic resonance spectroscopy may assist in determining if this is indeed the case. On the path to collection of those data, we do have empirical evidence supporting the effects of the technique on neuronal function. One such study demonstrated statistically significant improvements in mouse forelimb grip strength after toxin induced motor neuropathy in animals treated in the Resonator™ device. Electron microscopy of these neurons post treatment revealed enhancements in axonal regeneration as well as increased organization in mitochondrial and microtubular structure (1). Additional studies have shown that the Resonator™ device significantly modulates responsiveness in autonomic nerves in the heart and was able to affect atrial fibrillation utilizing a canine model (2). Nerve growth factors were used as targets in those studies In addition to the above described animal studies we have utilized the Resonator™ device in two IRB approved studies of its effects on Parkinson’s Disease in human subjects. Thus far, using both the UPDRS, the PDQ-39 and several other standardized scales, we have data that suggests our intervention may be effective across a several of the scales (both Motor and Non Motor symptoms) described above, and more specifically described in the section titled, “The Resonator™ as Applied to Improving the Signs and Symptoms of Parkinson's disease” on pages 12 through 14 above. While the studies mentioned above cannot confirm mechanism of action for the Resonator™ device in PD, they can provide evidence that the fields determined by Jacobson Resonance™ for the targeted Nerve Growth factors may ameliorate some of the signs and symptoms of PD. In addition to the device being designated as non invasive and non significant risk, we anticipate application of the intervention in an adjunctive manner to “standard of care” approaches now utilized by physicians in the treatment of Parkinson’s. Based on our observations, we expect that patients will enjoy major improvements in quality of life, across both motor and non motor symptoms associated with the disease. The following two articles provide additional information pertaining to the therapeutic use of pico-Tesla electromagnetic fields. The complete articles are contained in Appendix C of this protocol. 1. Saxena A., Jacobson J., Yamanashi W., Scherlag B., Lamberth J., Saxena B., A hypothetical mathematical construct explaining the mechanism of biological amplification in experimental model utilizing picoTesla (PT) electromagnetic fields, Medical Hypotheses , 2003 60(6), 821-839. 2. Scherlag BJ., Yamanshi WS., Yuemei H., Jacobson JI., Jackman WM., Lazzara R., Magnetism and Cardiac Arrhythmias, Cardiology in Review March/April 2004 12(2): 85-96 |
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