MICROCURRENT STIMULATOR
"ALPHA-STIM 100"
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Figure 1:Alpha-Stim 100 Waveform
Basically, the Alpha-Stim 100 is distinct and is based on the concept that the biophysics underlying the body's biochemistry also plays a significant role in regulating all of life's processes. Doctors are taught that there are out 75 trillion cells in a human body, each having an electrical potential across its cell membrane, similar to a battery, Alpha-Stim's proprietary waveform works by moving electrons through the body and brain at a variety of frequencies, collectively known as harmonic resonance. This normalizes the electrical activity of the nervous system and brain as measured by an electroencephalogram (EEG). In other words, this ensures the right frequency will be delivered to reestablish homeostasis within the affected bioelectrical system while the other frequencies pass harmlessly.
EVIDENCE (OR LACK) OF SCIENCTIFIC PRINCIPLES
Microcurrent stimulation is a form of bio-electric stimulation. Microcurrent electrical therapy represents a significant improvement in rapid pain control and acceleration of healing. It uses current in the microampere range, 1000 times less than that of TENS (Transcutaneous Electrical Nerve Stimulation) and below sensation threshold. The pulse width, or length of time that the current is delivered with a microcurrent device is much longer than previous technologies.
The scientific principle of the microcurrent stimulator is mainly due to its ability to stimulate cellular physiology and growth. One of the studies shows that it could increase ATP generation by almost 500%. It also enhances amino acid transport and protein synthesis. The injured area has a higher electrical resistance than the surrounding tissues. This results in decreased electrical conductance through the injured area and cellular capacitance, leading to impairment of the healing process and inflammation. Correct application of microcurrent electrical therapy to an injured site could allow cells in the traumatized area to regain their capacitance. Resistance is reduced, allowing bioelectricity to flow through and reestablish homeostasis. This process helps to initiate and perpetuate the many biochemical reactions that occur in healing. Electrical stimulation to the wound also tends to increase the amount of growth factor receptor which increases the amount of collagen formation.
For the principles of cranial electrotherapy stimulation, it is reported that the waveform generated by the device moves electrons through the body and brain at a variety of frequencies, collectively known as harmonic resonance. This normalizes the electrical activities of the nervous system and brain. Thus, the interrupted brain waves of persons suffer from anxiety, depression and insomnia could be normalized. The chart below shows the EEG before treatment and EEG after treatment.
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Figure 2:
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Figure 3
The above chart shows the 100 research studies on microcurrent electrical therapy. The results have proven that most of the patients gain marked improvement in their pain, anxiety, depression or insomnia although not many of them receive complete improvement after treated by Alpha-Stim 100. In short, the overwhelming majority of scientific research is extremely positive. No significant lasting side effects have been reported.
These studies more or less indicate that Alpha-Stim microcurrent therapy is safe and effective means of managing a wide variety of disorder. This technology may sound too good to be true when compared with the medical model based solely on chemistry. But it is true, as the following studies and clinical evidence indicates, because it balances the endogenous bioelectrical control systems.
QUESTIONABLE EFFICACY OF MICROCURRENT STIMULATOR
Several researches and surveys have been made and they prove the efficiency of the microcurrent stimulator to cure pain, anxiety, depression and insomnia. There is high percentage of users reported to feel the significant changes after treatment. However, there are a few questions arising regarding the efficacy of the microcurrent stimulator. Is microcurrent stimulator really helps the patient to ease their pain or the pain returns after the device is turned off?
Till now, the fundamental principles of the interaction of electric field and neurons is not completely understood. Another doubt raised is the interface between electrodes applying the current and neural tissue to be stimulated. The excitable tissues to be stimulated are in all cases surrounded by an extracellular fluid with relatively high conductivity. The electrodes used for electric stimulation are always placed in this "volume conductor". Current in the wires to the electrodes is carried by electrons, whereas current in the volume conductor is carried by ions. Chemical reactions at the interface will take place, and these reactions are still poorly understood. The waveforms used to apply the current can significantly affect the threshold, the electrochemistry at the electrode site, and tissue damage.
Even though there has no clear documentation of adverse effects exists to date following the use, however, this doesn't mean that this medical device would not bring long term side effects to the users. This issue should not be neglected as the users' safety is the most important consideration in the design of a medical device.
The Food and Drug Administration has been receiving inquires and consumer complaints about some microcurrent stimulator which has been widely promoted for relieving pain and treating a variety of other medical problems. These products has not been approved by the FDA. Because its medical claims, the stimulator is considered a medical device. The manufacturer, however, have not complied with any FDA regulations that govern the marketing of medical devices. These companies have submitted no information to FDA showing that the device is either safe or effective. From this, we should aware that not all microcurrent stimulator available in market is reliable. These products, which is not scientifically tested, is hazardous to the user and may cause unwanted side effect instantly or in long term.
Some may question the possibility to design a medical device which is 'totally' safe. However, in order to give maximum assurance and reliability to the users, the move to continuously improve and assess the medical device is necessary.
POTENTIAL HAZARDS TO THE USERS
Although the Alpha-Stim 100 has been independently tested by agencies in order to provide assurance of conformity to applicable standards for medical equipment safety and electromagnetic compliance, the users are still exposed to danger if there is any misuse of the device. According to the researches, this microcurrent stimulator may effect the operation of cardiac pacemakers, particularly demand type pacemakers. Furthermore, stimulate directly on the eyes, or over the carotid sinus, on the neck beside the larynx may bring harm to the users. Thus, the users have to follow the manual strictly before using the device. Without adult supervision, children should not use or handle this device.
The Alpha-Stim 100 is used externally only. To ensure the safety of the users, operating potentially dangerous machinery or vehicles during, and in some cases, for several hours after treatment is not advisable. Besides that, caution is advised in cases where other forms of analgesia (pain control) would not be used; such as to retain the beneficial aspects of pain for diagnosis or in cases where people may overuse pain-controlled areas. This medical device is good in relieving pain. However, there have been isolated reports of blood pressure being lowered by CES, so care should be taken while using the Alpha-Stim 100 with high blood pressure medication. In addition, safety of stimulation has not been established during pregnancy.
According to the surveys conducted to 4058 patients with the use of CES, certain complications have been reported. There are dizziness (6 cases, 0.15%), skin irritation/electrode burns (5 cases, 0.12%) and headaches (9 cases, 0.22%). Surveys also have shown that prolonged CES treatment at higher than necessary currents may cause dizziness or nausea that can last from hours to days. Besides, treatment immediately prior to going to sleep may cause difficulty sleeping due to increased alertness. Paradoxical reactions such as hyperexcited states, increased anxiety and sleep disturbances may occur.
Due to the potential hazards of this microucurrent stimulator to the users, further scientific researches should be conducted continuously to minimize the possibility of adverse effect.
RECOMMENDATION OF ITS USE
Although the Alpha-Stim 100 Microcurrent Stimulator is claimed to have no significant side effect, however, reasonable careful steps should be taken when using it. Furthermore, the user must also make sure that every treatment is necessary and the device is operated according to the user manual.
As a whole, this medical device is suitable for almost every user who suffers from pain, anxiety, depression and insomnia. However, there are special cases where it is not suitable for certain type of patients. Together with this, recommendations of the use of this home use medical device are further described as follows.
Some patients experience skin irritation or hypersensitivity due to the conductive medium or electrical stimulation. This condition can usually be reduced by alternative electrode placement or use of different conductive medium. Precaution measures should be taken if the patient is found to be in the presence of tendency to hemorrhage following acute trauma, recent surgical procedures, menstruating uterus and sensory nerve damage.
Microcurrent electrical therapy will not work for everyone. According to a research done, in nearly all cases of failure, the common denominator is that the patient has had a significant exposure to a strong electrical current. This means that the use of microcurrent stimulator is not encouraged for them. This may due to the previous treatment with miliampere TENS (Transcutaneous Electrical Nerve Stimulation) or similar modalities for a prolonged period of time. As yet, there is still no known effective method for this type of patient. Patients who have surgical or traumatic scars are also not encouraged to use the microcurrent stimulator. Scar tissue impedes the systemic flow of endogenous bioelectricity because it is a poor conductor of electricity. Accordingly, scar tissue may interfere with the patients' entire bioelectrical system.
This medical device is not recommended for persons with implant cardiac pacemaker. This is because the electrical pulse generated by the microcurrent stimulator may cause interruption to the electrically-sensitive pacemaker. Cardiac disorder may occur as a result of the interruption. Furthermore, safety has not been established for the use of electrical stimulation devices during pregnancy.
The users are also advised not to place the electrodes over the neck or mouth area because it will cause severe spasm of the laryngeal or pharyngeal muscles. The contractions may be strong enough to close the airway and cause difficulty in breathing. Besides that, the users are not encouraged to use electrical stimulation over swollen, infected areas or skin eruptions. This may cause the condition of affected part becomes even worse.
Besides that, it is recommended that the cranial electrotherapy stimulation be used at least 3 hours before going to sleep. It is because paradoxical reactions such as hyperexcited states, increased anxiety and sleep disturbances may occur.
If the user could follow strictly the above recommendation and the user manual provided by the vendor, they can reduce the possibility of unfavorable contradictions. The patient can get the most effective treatment only if the device is used correctly and accurately.
SUMMARY
Alpha-Stim 100 is a commercial microcurrent stimulator that has been claimed to effectively treat pain, anxiety, depression and insomnia. Although scientific researches have been carried out to prove the reliability of this medical device, some doubts and questions have been raised regarding the efficacy of this device. It is suggested that further tests should be carried out to verify that this device does perform all the treatments as stated.
Alpha-Stim 100 has two main features, they are microcurrent electrical therapy (MET) for pain treatment and cranial electrotherapy stimulation for anxiety, depression or insomnia treatment. Both of the features apply exactly the same principles, the only difference is the type of electrode used. For MET, hand-held electrode is used to apply on traumatized area. For CES, clip electrodes are attached on the ear lobes when treatment is given.
Consumer is encouraged to check whether the type of commercial microcurrent stimulator purchased is compliance to the standards set by certain institutes and bodies. It is not advisable to purchase microcurrent stimulator which has not been clinically tested. If user finds any doubts, they should refer to the local dealers and medical doctors.
REFERENCES
- Black,J (1987). Electrical stimulation: Its role in growth, repair and remodeling of the musculoskeletal system. Praeger: New York
Mercola.J.M & Kirsch, D (1995). The basis for microcurrent electrical therapy in conventional medical practice.Journal of Advancement in Medicine,Vol 8,No 2.
Braun,W.P (2000). Feedback-modulated microcurrent in acupuncture treatment.A Journal for physicians by physicians, Vol 12, No 2.
Kirsch, D.L & Lerner, F.N. Transcutaneous electrical nerve stimulation. The textbook of the American Academy of Pain Management
http://www.microcurrentresearch.com/mcr_html.files/research.html