PainRelief.com Interview with:
Steve Haltiwanger, MD, CCN, FAIS
Chief Medical Officer of Electromedical Products International, Inc.
PainRelief.com: What is the background for the Alpha-Stim M CES/microcurrent therapy device? Where does the name come from?
Response: Before 1978 when the FDA changed the terminology, cranial electrotherapy stimulation (CES) was referred to as “electrosleep.” Early CES devices were used to induce sleep through the application of small amounts of electrical stimulation to the brain. As research progressed, many other effects were identified, including treatment of anxiety, depression, and pain./
A 1965 CES EEG study found that CES treatments increase the production of alpha rhythms in the brain (Magora et al., 1965). Increased alpha correlates with improved relaxation and increased mental alertness or clarity. In 2004 it was reported that Alpha-Stim CES treatments induced changes in the EEG, increasing alpha (8-12 Hz) relative power and decreasing relative power in the delta (0–3.5 Hz) and beta (12.5-30 Hz) frequencies (Kennerly, 2004).
In 1970 (Jarzembski et al.) determined that when CES was applied to the head of a primate, the electrical current penetrated every region of the brain with the flow notably channeled through the limbic system.
Many symptoms seen in psychiatric conditions, such as anxiety and insomnia, are found to be exacerbated by excess cortical activation (Yassa et al., 2012; Bonnet et al., 2010). An Alpha-Stim fMRI study in an anxiety population showed that CES, after one 20-minute treatment, causes cortical brain deactivation in the midline frontal and parietal regions of the brain (Feusner et al., 2012). Another fMRI study was conducted as part of a randomized, double-blind study in a pain population revealed more significant decreases in average pain levels (P=.023) than those using a sham device or receiving usual care without CES. The active CES device was shown to significantly decrease activation of central pain processing regions of the brain, such as the cingulate gyrus, insula, and prefrontal cortex, compared to the sham device (Taylor et al., 2013).
Alpha-Stim CES deactivates brain regions associated with overuse, consistent with various disorders such as anxiety, insomnia, depression, and pain (Taylor et al., 2013; Feusner et al., 2012).
The above mechanisms provide evidence that Alpha-Stim CES changes brainwave electrical activities and brain activity. These changes are consistent with a decrease in anxiety and depression and an increase in relaxation that can help people fall asleep and control insomnia.
It was through reviewing the research EEG studies on CES devices that inventor Dr. Daniel L. Kirsch named his device Alpha-Stim®, which entered the market in 1981.
The Alpha–Stim M is both a cranial electrotherapy stimulator and a microcurrent electrotherapy medical device that uses an extremely low current electrical signal delivered in a patented waveform. When used for cranial electrotherapy stimulation, a current of 100 to 600 microamperes (µA) is used at a variable frequency of up to 0.5 Hz applied with earclip electrodes. The device can be used for the treatment of anxiety, insomnia, depression, and to treat central pain syndromes such as fibromyalgia which there are three randomized clinical trials on using Alpha-Stim CES showing robust results (Lichtbroun et al., 2001; Cork et al., 2004; Taylor et al., 2013). The device consists of an electrical pulse generator that is operated by two 1.5-volt batteries. An electroconductive solution is used for moistening the electrodes to ensure good electrical contact through the skin.
The Alpha-Stim® 2000 was first introduced in 1981, while the newest Alpha-Stim® models AID and M were introduced in 2012. There have been multiple changes in device design over the years, but the waveform and output parameters have remained the same. Because the output characteristics have remained constant over 39 years, individuals and research subjects have always received the same Alpha-Stim treatment. Therefore, all research performed using previous models of Alpha-Stim® since 1981 is still valid with the new models. And there are over 100 studies performed on it to date.
PainRelief.com: What are the main indications? How does it work? What types of pain does it ameliorate, and for what patient’s ages/groups?
Response: The Alpha-Stim M also provides Microcurrent Electrical Therapy (MET), which is effective in all age groups. This electrical stimulation utilizes a patented microcurrent waveform, that is effective in chronic pain, acute pain, and post-traumatic pain management. Multiple clinical studies using the Alpha-Stim for pain management can be found on the website https://www.alpha-stim.com/healthcare-professionals/treating-pain/
The Alpha-Stim M uses two Smart probes and silver chloride AS-Trode adhesive electrode pads for peripheral pain control. The MET provided by the Alpha-Stim M uses a 10-second complex waveform to send electrical signals through a painful area. Alpha-Stim MET will change the peripheral and central pain signals, unlike milliamperage TENS units that send pulsed electrical signals that stimulate peripheral sensory nerves to block pain at the level of the spinal cord by the pain gate control mechanism. Pain control with TENS is transient, whereas Alpha-Stim pain research shows that the effect is prolonged and cumulative over time, giving more sustained relief. MET will augment the flow of endogenous electrical currents, which reduces the electrical resistance of injured tissue. Specific biological effects have been found with the use of MET devices, including increased ATP generation and protein synthesis, whereas TENS treatments can reduce ATP and protein synthesis.
PainRelief.com: What should readers take away from your report?
Response: A 2019 survey was sent to Alpha-Stim practitioners. One hundred eleven practitioners responded to the survey. The Alpha-Stim practitioner survey is a valuable tool utilized by EPI to help determine the future direction of the Alpha-Stim device, clinical and customer support as well as educational opportunities.
The Alpha-Stim survey was well received by practitioners, with 98% of respondents reporting Alpha-Stim was easy to use, and 100% of providers reporting Alpha-Stim is safe.
Ninety-two out of 111 practitioners responded “Yes” concerning their belief that using the Alpha-Stim is effective in treating pain. One hundred six out of 111 practitioners responded “Yes” about recommending Alpha-Stim for use to their colleagues.
PainRelief.com: Is there anything else you would like to add?
Response: CES is non-invasive, and side-effects are mild and self-limiting. An FDA commissioned a review of the safety of CES by the National Research Council (1974, p.42) stated, “significant side effects or complications attributable” to the application of electric current of approximately one milliampere or less for “therapeutic effect to the head” (i.e., cranial electrotherapy stimulation) were “virtually nonexistent.” The Alpha-Stim device uses ~ 50% of this amount of current at the highest CES setting. A review of Alpha-Stim CES studies using human subjects revealed that the incidence of adverse events was <1%, and all were mild and self-limiting.
Bonnet MH, Arand DL. (2010). Hyperarousal and insomnia: State of the science. Sleep Medicine Reviews,14:9-15.
Cork RC, Wood P, Ming N, Shepherd C, Eddy J, Price L. (2004). The Effect of Cranial Electrotherapy Stimulation (CES) on Pain Associated with Fibromyalgia. The Internet Journal of Anesthesiology, 8(2).
Feusner JD, Madsen S, Moody TD, Bohon C, et al. (2012). Effects of cranial electrotherapy stimulation on resting state brain activity. Brain and Behavior, 2(3): 211-220.
Jarzembski WB, Laarson SJ, Sances A Jr. (1970). Evaluation of specific cerebral impedance and cerebral current density. Annals of the New York Academy of Sciences, 170, 476-490.
Kennerly R. (2004). QEEG analysis of cranial electrotherapy: A pilot study. Journal of Neurotherapy, 8,112-113.
Lichtbroun AS, Raicer MC, Smith RB. (2001). The treatment of fibromyalgia with cranial electrotherapy stimulation. Journal of Clinical Rheumatology, 7(2), 72-78.
Magora F, Beller A, Aladjemoff L, Magora A, et al. (1965). Observations on electrically induced sleep in man. British Journal of Anesthesiology, 37, 480-491.
National Research Council. (1974). An Evaluation of Electroanesthesia and Electrosleep: Study Commissioned by the US Food and Drug Administration. https://books.google.com/books?id=WksrAAAAYAAJ&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=false
Taylor AG, Anderson JG, Riedel SL, Lewis JE, et al. (2013). A randomized, controlled, double-blind pilot study of the effects of cranial electrical stimulation on activity in brain pain processing regions in individuals with fibromyalgia. Explore, 9(1), 32-40.
Yassa MA, Hazlett RL, Stark CE, Hoehn-Saric R. (2012). Functional MRI of the amygdala and bed nucleus of the stria terminalis during conditions of uncertainty in generalized anxiety disorder. Journal of Psychiatric Research, 46, 1045-1052.
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