Both the ALPHA-STIM® 100 and ALPHA-STIM® SCS (Stress Control System) treat anxiety, depression and insomnia. The ALPHA-STIM® 100 also treats acute, chronic, and postoperative pain and the ALPHA-STIM® PPM (Personal Pain Manager) is designed as an alternative to TENS for localized treatment of pain. The primary distinctive feature in these medical devices is the waveform, and ALPHA-STIM® has a uniquely effective waveform. The application of direct electrical treatment to the brain, along with our treatment protocols for pain also makes the difference that no other device has been able to emulate. Further, ALPHA-STIM® technology has been shown to be far more cost effective than prescription drugs.
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WHAT IS CRANIAL ELECTROTHERAPY STIMULATION (CES)?
Cranial Electrotherapy Stimulation (CES) is a form of electromedicine. In 1966 and 1969, two international conferences were held in which Soviet block scientists shared with the rest of the world their research on CES and the related technology of electroanesthesia. These two conferences stimulated Western research interest in CES, and researchers in the United States, Europe and India started investigating CES. Research has found CES safe and effective for multiple therapeutic uses. Despite the positive findings of Western researchers, CES is just beginning to find fertile ground among Western clinicians. The approval of Alpha-Stim® SCS by the FDA in 1992 has provided official recognition of sufficient good science to apply CES as a safe and effective therapy for depression, anxiety, insomnia and pain. Even though CES has the advantage of providing treatment without the risk of serious side effects that accompany many pharmacotherapies, it remains largely unknown to most western physicians, psychiatrists and psychologists.
Cranial electrical stimulation (CES) is the deliberate application of low-level current, usually less than one milliampere to the head for a therapeutic purpose. The Alpha-Stim® Cranial Electrotherapy Stimulation (CES) uses a proprietary wave form of less than 600 Microamperes. This level of current used is significantly less than with the other two applications of current to the entire head, electroanesthesia and electroconvulsive therapy.
The United States Food and Drug Administration (FDA) has approved Alpha-Stim® CES for the treatment of insomnia, anxiety and depression (Code of Federal Regulations, title 21, vol. 8, section 882.5800). The FDA regulates the sale of CES equipment in the UnitedStates as a medical device and established the official name for all medical devices that put a low level current across the head as “cranial electrotherapy stimulation” (National Research Council, Division of Medical Science, 1974). The FDA requires a prescription by a licensed mental health or health care professional to legally obtain and use CES device in the U.S. In all other countries CES is an over-the-counter medical device that does not require a prescription. When used to treat pain, a CES device is considered by the FDA to be a transcutaneous electrical nerve stimulator (TENS) and is regulated in this category of medical device (Code of Federal Regulations, title 21, vol. 8, section 882.5890).
Acceptance of a therapy in modern western medicine is often based not just on objective evidence for its efficacy, but also on an explanation that explains the mechanism of action within already accepted medical knowledge and principles. The application of electrical currents to a site on the body which was in pain was a practice known to and used by ancient Egyptian and Greek physicians, but was not accepted in modern medical practice until the development of the gate control theory of pain. The history of the TENS unit is provided as an example of the long gap that can occur between the development of a therapeutic use for electric currents and its acceptance into orthodox medical practice. As far back as 1850, electric current was used to effectively treat pain, but until the gate control theory provided an explanation for why electricity could be used to reduce pain it was not accepted in mainstream Western medicine. The same sort of lag has occurred with Cranial Electrotherapy Stimulation (CES). The technology is not new, but despite many positive studies and FDA approval, it is relatively unknown. The reason CES has not been embraced by the medical community despite clear evidence of its efficacy may be the lack of a model for how it works.
There is currently no body of research that identifies the complete mechanism underlying CES. However, there is research that suggests some of the possible mechanisms involved. The literature on the neurochemical changes involved in CES reveals a picture of significant increases in neurotransmitters and hormones known to be involved in the regulation of sleep, pain, affect and stress responses. It has been reported that the application of low-level currents can speed healing in tissue by turning on the genetic machinery for cellular repair (Zhao, et al. 2006).
There are also indications that CES may have a normalizing effect on EEG. The use of CES has been found to normalize the EEG of pain patients. Human and animal research is clear that CES makes significant changes in the electrical and chemical activity of the brain and can lead to the cautious conclusion that CES has the basic effect of regulating and normalizing the neurochemical and neuroelectrical activity of the brain. Findings show that a single 20-minute session of CES has a significant effect on the cortical and subcortical activity of the human brain resulting in activity consistent with decreased anxiety and increased relaxation. Even a single session of CES can be expected to provide increased alpha relative power with concomitant decreased delta and beta relative power.
Microcurrent Electrical Therapy (MET) is a form of electromedicine. In 1995, Joseph M. Mercola and Daniel L. Kirsch coined the term "microcurrent electrical therapy" (MET) to define a new form of electromedical intervention. A growing body of research shows the effectiveness of MET to do more than control pain. MET can actually accelerate and even induce healing and can increase the amount of growth factor receptors, which increases collagen formation (Falanga et al. 1987). The first human study using direct current for wound healing was published by Assimacopoulos (1968). Wolcott et al. (1969) published frequently cited work using direct currents of 200 to 1000 µA to treat 67 patients. The study was repeated on 76 additional patients with 106 ischemic skin ulcers by Gault and Gates (1976). Rowley et al. (1974) showed that electrically stimulated ulcers had a fourfold acceleration in healing response compared to controls. Weiss et al. (1990) found that no significant adverse effects resulting from electrotherapy on wounds have been documented. Microcurrent electrical stimulation has also been used as an effective treatment for non-tumor bone fracture for several years (Brighten 1981; Friedenberg 1966; Friedenberg 1981; Yasuda 1953).
Becker (1985) found that repair of injury occurs in response to signals that come from the body’s electrical control system. In the 1960s he demonstrated that electrical current is the trigger that stimulates healing, growth, and regeneration in all living organisms.
A mechanism for Microcurrent Electrical Therapy (MET) has been proposed by Chang et al. (1982) who found that microcurrent stimulation increased adenosine triphosphate (ATP) generation by almost 500%. Increasing the level of current to higher milliampere levels actually decreased the results. ATP provides the energy tissues require for building new proteins and increases protein synthesis and membrane transport of ions (Kirsch 2002). Microcurrent was also shown to enhance amino acid transport and protein synthesis in the treated area 30 to 40% above controls.
Trauma affects the electrical potential of cells in damaged tissues (Becker 1985). Initially the injured site has a much higher resistance to the body’s normal electrical currents than the surrounding tissue, causing potentially healing bioelectricity to flow generally around the injury. The correct microcurrent application to an injured site augments the endogenous current flow. The resistance of the injured tissue is then reduced, allowing bioelectricity to enter the area to reestablish homeostasis.
When there is chronic pain the injury to peripheral neural axons can result in abnormal nerve regeneration following injury. The damaged axon may grow multiple nerve sprouts. These nerve sprouts, including those forming neuromas, can generate spontaneous activity, peaking in intensity several weeks after injury. Unlike normal axons, these structures are more sensitive to physical stimulation. After a period of time, atypical connections may develop between nerve sprouts in the region of the nerve damage, permitting “cross-talk” between efferent nerves and nociceptors.
Dorsal root (spinal) fibers may also sprout following injury to peripheral nerves. These factors can cause the perception of pain in the absence of the normal activation of the nociceptive system by noxious stimuli.
(Source: Pain Management: Pathophysiology of Pain and Pain Assessment, 2007)
The approval of Alpha-Stim® by the FDA in 1990 has provided official recognition of sufficient good science to apply MET as a safe and effective therapy for pain. (510k No. K896948). The FDA regulates the sale of Alpha-Stim® equipment in the United States as a medical device. The FDA requires a prescription by a licensed health care professional to legally obtain and use this device in the U.S. In all other countries, it is an over-the-counter medical device that does not require a prescription. When used to treat pain, the Alpha-Stim® device is considered by the FDA to be TENS (transcutaneous electrical nerve stimulator) and is regulated in this category of medical devices (Code of Federal Regulations, title 21, vol. 8, section 882.5890).
Even though MET has the advantage of providing treatment without the risk of serious side effects that accompany many pharmacotherapies, it remains largely unknown to most western practitioners. Acceptance of a therapy in modern western medicine is often based not just on objective evidence for its efficacy, but also on an explanation that explains the mechanism of action within already accepted medical knowledge and principles. The application of electrical currents to a site on the body which was in pain was a practice known to and used by ancient Egyptian and Greek physicians, but was not accepted in modern medical practice until the development of the gate control theory of pain (Melzack and Wall 1965). The history of the TENS unit is an example of the long gap that can occur between the development of a therapeutic use for electric currents and its acceptance into orthodox medical practice.
The potential of microcurrent therapy in health care has only recently attracted serious attention. Like many biological phenomena, knowledge of the very existence of small currents in the body had to wait on the development of technology sophisticated and sensitive enough to study them (Morareidge, 2006). MET does more than just block pain. Because MET uses such a small current, typically less than 600 microamps, there is no patient discomfort or even sensation during application. In a data collection study (Wallace, 1990) 94% of the 1531 patients experienced a reduction in pain during the first treatment and 88% were pain free within 10 treatments.