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Scrambler Therapy theory bases

Electro-analgesia was first introduced in an empirical form, utilizing at first animal sources of electricity (torpedoes), then static,galvanic and alternate sources, to the most modern TENS and implant devices. The Electro-analgesia theoretical referencebasis was created by R. Melzack and P.D. Wall, who in 1965 published the Gate Control theory (Melzack R, Wall PD. Pain

mechanisms: a new theory. Science. 150(699):971-9, 1965).

This theory is still today a primary theoretical reference for all electro-analgesiaand neuro-modulation procedures, even if it is not considered exhaustive. On theother hand, both technological and implant stimuli techniques have greatlychanged over time. In general, the ultimate purpose of these techniques is alwaysto inhibit pain impulse transmission using an electric stimulus (of various naturedepending on the device utilized). In scientific literature there are reference worksthat define limits and application fields of the various techniques andtechnologies used today, to be consulted for further information on this issue.

The Gate Control theory, though widely applied in the historical development ofelectro-analgesia, has significant limitations concerning the analyticalrepresentation of chronic pain in its various neurological and pathologicalmechanisms. The most significant observed gap is that while this theory can

interpret "mechanical" pain transmission methods, it cannot interpret properties of the associated information, such asemerging properties and pain response in the most elevated and complex systems such as memory and learning. Theseresponses are non-linear and dynamically variable through time, compared to the pain stimulus itself.

Even though the CNS by nature continuously generatesand processes data, this is never explained analyticallyand theoretically, only in very generic descriptive termssuch as "electrical impulses", therefore missing afundamental characteristic description.This limitation of the theoretical analysis is not a problemfor devices that work on the inhibition of paintransmission, since their implicit purpose is to suppressthis information. This analysis is relevant however in thedifferent type of approach for the theoretical and analyticalstudy of pain control that led to the creation of theScrambler Therapy.

Therefore, considering these facts, in order to exceedefficacy limits of protocol cures, a different referencemodel has been developed. Basically, it was necessary tocreate a more appropriate theoretical model to cybernetically interpret the dynamics of the pain system (processes ofcommunication and regularization) and the system's complexity in order to explain the non-linear and complex dynamics ofchronic pain. The developed theoretical model analyses the immediate effects (instant analgesia during treatment) and themedium/long term remodeling (thresholds) of the pain system as far as perception is concerned.Simplified model of scrambler therapy

In order to achieve this goal, it was necessary to implement the information theory in a more complex analysis system, basedupon a "black box" in which the complexity level of emerging properties that characterize pain information was fixed arbitrarilyon the genesis of action potentials that trigger a chain of pain information transmission. This modality implicitly includes the roleof the various molecules involved in the modulation of pain (all virtually included in the black box), as they are functionallyrepresented by involved action potentials.Therefore, this model no longer treats action potentials as simple "impulses," but ascomplex information strings.

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It may thus be reasonably assumed that it is possible to control the lower levels of the complexity of the pain system (thechemical reactions regulating the coding of pain information and subsequent feedback) by manipulating the "information"variable alone at higher levels of complexity.

To further comprehend the information concept utilized see the information theory (Claude Shannon, 1948). In a nutshell,information requires a coding system based on signs and rules. For example, the alphabet expresses signals, but rules are

necessary in order to create meaningful sentences for the reader.

Letters assembled in a random manner, although recognizable as signals, do not constitute information. Similarly, actionpotentials generated sequentially by a stimulated receptor cannot be interpretable without an analytical model of "informationcoding" rules. For example, frequency modulation of action potentials gives us an idea of the stimulus intensity, but it does nottell us how its perception is coded in terms of different sensations, nor does it tell us how thermal sensation is coded differentlyfrom painful sensation with respect to information. Actually, based on simple coding of information in frequency modulation, itwould theoretically and technically be possible to artificially reproduce any kind of sensation, but we know this is not so. Thisproblem of coding/decoding system analysis in the C.N.S. does not limit itself only to frequency modulation. If this were true, anytype of sensory trick could have achieved it using very simple technologies.

During the development of Scrambler Therapy, artificial neurons were developed to transmit to the C.N.S. informationrecognizable as "self" and "non pain" in a non-invasive manner through surface C receptors. Compared to the conventionalelectro-analgesia, the assumed active principle that is currently under trial is not to inhibit pain transmission (through A-betafiber excitation), but to substitute pain information with synthetic "non pain" information.

The study’s main focus is to continue the theory validation process through always more meaningful progressive testing proof,clearly consistent with the developed method’s expectations and emerging data. In this case, considering this theory model’sexpected high analgesic efficacy in cases not normally responsive or poorly responsive to the most effective drug protocoltreatments, and conventional electro-analgesia (TENS, implanted devices), the normal reference testing model is a perspectivecomparative clinical study. The advantage of this approach is that it can also compare the study’s emerging results with a broadand diversified scientific literature. This enables comparisons with well-consolidated scientific data coming from differentsources. Biochemical or image studies of clear interest .

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