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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 reference basis 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-analgesia and neuro-modulation procedures, even if it is not considered exhaustive. On the other hand, both technological and implant stimuli techniques have greatly changed over time. In general, the ultimate purpose of these techniques is always to inhibit pain impulse transmission using an electric stimulus (of various nature depending on the device utilized). In scientific literature there are reference works that define limits and application fields of the various techniques and technologies used today, to be consulted for further information on this issue.

The Gate Control theory, though widely applied in the historical development of electro-analgesia, has significant limitations concerning the analytical representation of chronic pain in its various neurological and pathological mechanisms. 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 as emerging properties and pain response in the most elevated and complex systems such as memory and learning. These responses are non-linear and dynamically variable through time, compared to the pain stimulus itself.

Even though the CNS by nature continuously generates and processes data, this is never explained analytically and theoretically, only in very generic descriptive terms such as "electrical  impulses", therefore missing a fundamental characteristic description.
This limitation of the theoretical analysis is not a problem for devices that work on the inhibition of pain transmission, since their implicit purpose is to suppress this information. This analysis is relevant however in the different type of approach for the theoretical and analytical study of pain control that led to the creation of the Scrambler Therapy.

Therefore, considering these facts, in order to exceed efficacy limits of protocol cures, a different reference model has been developed. Basically, it was necessary to create a more appropriate theoretical model to cybernetically interpret the dynamics of the pain system (processes of communication and regularization) and the system's complexity in order to explain the non-linear and complex dynamics of chronic pain. The developed theoretical model analyses the immediate effects (instant analgesia during treatment) and the medium/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, based upon a "black box" in which the complexity level of emerging properties that characterize pain information was fixed arbitrarily on the genesis of action potentials that trigger a chain of pain information transmission. This modality implicitly includes the role of the various molecules involved in the modulation of pain (all virtually included in the black box), as they are functionally represented by involved action potentials.Therefore, this model no longer treats action potentials as simple "impulses," but as complex information strings.

It may thus be reasonably assumed that it is possible to control the lower levels of the complexity of the pain system (the chemical 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, action potentials generated sequentially by a stimulated receptor cannot be interpretable without an analytical model of "information coding" rules. For example, frequency modulation of action potentials gives us an idea of the stimulus intensity, but it does not tell us how its perception is coded in terms of different sensations, nor does it tell us how thermal sensation is coded differently from painful sensation with respect to information. Actually, based on simple coding of information in frequency modulation, it would theoretically and technically be possible to artificially reproduce any kind of sensation, but we know this is not so. This problem of coding/decoding system analysis in the C.N.S. does not limit itself only to frequency modulation. If this were true, any type 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. information recognizable as "self" and "non pain" in a non-invasive manner through surface C receptors. Compared to the conventional electro-analgesia, the assumed active principle that is currently under trial is not to inhibit pain transmission (through A-beta fiber 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’s expected high analgesic efficacy in cases not normally responsive or poorly responsive to the most effective drug protocol treatments, and conventional electro-analgesia (TENS, implanted devices), the normal reference testing model is a perspective comparative clinical study. The advantage of this approach is that it can also compare the study’s emerging results with a broad and diversified scientific literature. This enables comparisons with well-consolidated scientific data coming from different sources. Biochemical or image studies of clear interest .