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Alpha-Stim Technology

 

Electromedical Products International, Inc. (EPI) was established in 1981 by Dr. Daniel L. Kirsch to develop, manufacture and market Alpha-Stim technology worldwide. The company was launched with a sophisticated clinical model, the Alpha-Stim 2000 which weighed over 40 pounds and cost US$5,850. Since that time, the company has taken advantage of advances in electronics and computer technology to bring the size and price down significantly while improving efficacy and ease of use. This is accomplished partially through the development of clinical protocols that are proven to work.

EPI devices have FDA approval and has obtained the CE Mark, gaining regulatory market approval for all European countries. EPI has also been awarded the UL (Underwriters Laboratory), Health Canada and Canadian UL, Australia TGA, and New Zealand Medsafe Listing no: ARTG No. 137247.  The company is ISO 13488 certified.

EPI is truly a global enterprise. Alpha-Stim medical devices are manufactured and distributed with manuals and product brochures in seven languages to users in over 120 countries. There have been over 8 million Alpha-Stim users in the USA alone.

Alpha waves

"Alpha waves are electromagnetic oscillations in the frequency range of 8-12 Hz arising from synchronous and coherent (in phase / constructive) electrical activity of thalamic pacemaker cells in the human brain. They are also called Berger's wave in memory of the founder of EEG.(Brazier 1970)" -- Wikipedia.

Alpha waves are one type of brain waves, commonly detected by electroencephalography (EEG) or magnetoencephalography (MEG) and predominantly found to originate from the occipital lobe during periods of relaxation or sleep, with eyes closed but still awake. Conversely alpha waves are attenuated with open eyes as well as by drowsiness and sleep. They are thought to represent the activity of the visual cortex in an idle state.

The Alpha-Stim has been shown in clinical studies to increase the brain's production of serotonin, beta endorphins, and alpha wave activity.  Alpha waves are the brain waves one feels when they are alert yet relaxed. Decreased alpha wave activity is shown in a variety of psychological disorders.  The brain produces four main types of brain waves as shown below:

The generally accepted brain wave groups:

1. Beta Waves: 12 - 26 Hz. Beta waves are associated with high stress, high concentration, busy or anxious thinking

2. Alpha Waves: 8 - 12 Hz. Alpha waves are seen when we are both alert and relaxed. These waves decrease with concentrated or busy activity. ..

3. Theta Waves: 4 - 8 Hz The sleepy brain waves. We see these brain waves when we are falling asleep or just waking up and during the early stages of sleep

4. Delta Waves: 0 - 4 Hz Delta waves are the slowest range of brain waves. They are seen in deep sleep typically during stage 3 and stage 4 sleep.

Your brain can produce a variety of these types of wave forms at any given time. By analyzing brain waves of some people with psychological disorders, there can be obvious flaws. Some have irregular brain wave patterns while others are dominant in certain frequencies or deficient in others. High beta wave/low alpha wave activity has been shown in people with mood disorders, stress, anxiety, epilepsy, and even schizophrenia. Conversely, children with ADHD typically have slower brain waves than most (delta and theta brain wave activity) and decreased power in the alpha bands. For this reason many are prescribed stimulants in order to speed up their brain wave activity.

Increased alpha wave activity, while not a cure-all, has shown to help with a variety of mental health issues. Increasing your alpha waves can also be a means of just managing stress. Zen Buddhists, biofeedback therapists, and even NASA scientists have all sought ways to increase beneficial alpha wave activity over the years. As psychotherapy research progresses, alpha wave enhancement will become an even more important tool in fighting mental illness.

Frequency Display

EEG before treatment (Left )


This first chart shows a typical pain patients brain waves averaged over two minutes. This is an abnormal frequency pattern.

EEG after treatment (Right)

This second chart was taken from the same patient after 10 minutes of Alpha-Stim use. It shows beneficial smoothing of the brain waves to a normal pattern.

From research by Dr. Michael Heffernan. Comparative Effects of Microcurrent Stimulation on EEG Spectrum and Correlation Dimension. From the journal Integrative Physiological and Behavioral Science, 31(3):202-209, 1996.

 

How does the Alpha-Stim work?

 

The Alpha-Stim 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. There are about 75 trillion cells in a human body, each having a small electrical potential of ~80mV 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).

 

The exact mechanism by which Alpha-Stim produces its effects is not fully understood. However, based on previous and ongoing studies, it appears that the Alpha-Stim microcurrent waveform activates particular groups of nerve cells located at the brainstem, a site at the base of the brain that sits atop of the spinal cord. These nerve cells produce the chemicals serotonin and acetylcholine, which can affect the chemical activity of nerve cells that are both nearby and at more distant sites in the nervous system.

 

 

A work above by Kennerly (2006) has shown beneficial changes in brain activity after a single 20-minute treatment with Alpha-Stim CES. Blue shows a decrease in delta frequency (slow brain waves) activity while red shows an increase in alpha (relaxation waves) frequency activity

Today Alpha-Stim, has evolved to become a very useful tool which helps regulate the body's own electrical impulses in a safe, easy and comfortable way.

Both the Alpha-Stim 100 and Alpha-Stim SCS (Stress Control System) treat anxiety, stress and insomnia. The Alpha-Stim 100 and Alpha-Stim PPM (Personal Pain Manager) also treats acute, chronic, and postoperative pain. The primary distinctive feature in a medical device is the waveform, and Alpha-Stim has a uniquely effective waveform. The application of direct electrical treatment to the brain, along with treatment protocols for pain also makes the difference that no other device has been able to emulate.

There are three ways to prove that a medical product is effective: research, surveys, and professional endorsements. Alpha-Stim has substantial evidence from all three. There is more research supporting Alpha-Stim than any other therapeutic device and even more than many drugs. Many of the studies were double-blind. The detailed research results and reports are available here. 

Clinical Results

In addition to the research, physicians documented Alpha-Stim technology in a comprehensive retrospective surveys. The degree of significant improvement (of 25% or more) in 500 patients was 91% for pain, 94% for anxiety, 90% for stress related illnesses, and 79% for insomnia. (See details below). More than half of the patients exhibited an improvement of 50% or more. Supported by the double-blind studies, these surveys provide a good overview of results at a glance. The results from Peer-Reviewed Outcomes on 2,500 Alpha-Stim Patients Self-Reports are also listed below.

Physician Post-Marketing Survey on 500 Alpha-Stim Patients

   Condition
NWorseNo ChangeSlight <24%

Fair

25-49%

Moderate 50-74%Marked 75-99%Complete 100%Significant >25%
Pain
286
.35%
1.75%
6.99%
16.78%
26.92%
37.76%
9.44%
90.91%
Anxiety
349
0%
2.29%
4.01%
11.17%
25.5%
51.86%
5.16%
93.7%
Depression
184
0%
4.35%
5.89%
16.85%
20.65%
44.57%
7.61%
89.67%
Stress
259
0%
2.32%
4.63%
14.29%
27.03%
47.88%
3.86%
93.05%
Insomnia
135
0%
11.85%
8.89%
12.59%
25.19%
33.33%
8.15%
79.26%
Headache
151
.66%
5.3%
3.97%
16.56%
21.19%
41.72%
10.6%
90.07%
Muscle Tension
259
.77%
2.32%
2.32%
16.22%
29.34%
42.86%
6.18%
94.59%

Results of using Alpha-Stim technology as reported by healthcare practitioners. Total N = 500 patients with multiple symptoms. For additional information see the book: Kirsch, Daniel L. The Science Behind Cranial Electrotherapy Stimulation. Medical Scope Publishing Corporation, Edmonton, Alberta, Canada, 2002.

Peer-Reviewed Outcomes on 2,500 Alpha-Stim Patients Self-Reports

    Condition
N

Slight

<24%

Fair

25-49%

Moderate

50-74%

Marked

75-100%

Significant

>25%

Pain (all cases)
1949
6.98%
31.97%
38.02%
23.04%
93.02%
Back Pain
403
4.69%
27.05%
38.96%
29.03%
95.04%
Cervical Pain
265
6.79%
26.04%
47.17%
20%
93.21%
Hip/Leg/Foot Pain
160
3.75%
26.88%
33.13%
36.25%
96.25%
Shoulder/Arm/Hand Pain
150
8.67%
27.33%
42%
22%
91.33%
Carpal Tunnel
25
0%
20%
68%
12%
100%
Arthritis Pain
188
5.85%
27.13%
46.81%
20.21%
94.15%
TMJ Pain
158
10.76%
37.97%
37.97%
13.29%
89.24%
Myofascial Pain
62
9.68%
29.03%
29.03%
32.26%
90.32%
RSD
55
18.18%
29.09%
34.55%
18.18%
81.82%
Fibromyalgia (alone)
142
9.15%
37%.32%
36.62%
16.9%
90.85%
Fibromyalgia (with other)
363
9.09%
36.09%
41.87%
12.95%
90.91%
Migraine
118
1.69%
41.53%
25.42%
31.36%
98.31%
Headaches (all other)
112
17.86%
26.79%
21.43%
33.93%
82.14%
Psychological (all cases)
723
8.44%
24.2%
32.78%
34.58%
91.56%
Anxiety (alone)
128
10.16%
22.66%
32.81%
34.38%
89.84%
Anxiety (with other)
370
8.92%
22.97%
32.97%
35.14%
91.08%
Anxiety/Depression
58
5.17%
32.76%
32.76%
29.31%
94.83%
Depression (alone)
53
13.21%
20.75%
43.4%
22.64%
86.79
Depression (with other)
265
10.94%
23.02%
35.09%
30.94%
89.06%
Stress
123
4.88%
24.39%
31.71%
39.02%
95.12%
Chronic Fatigue
50
6%
60%
20%
14%
94%
Insomnia
163
6.13%
28.83%
28.83%
36.2%
93.87%

Results of using Alpha-Stim technology at least 3 weeks from consecutive warranty cards. Total N = 2,500 patients with multiple symptoms. For additional information see: Smith, Ray B. Is microcurrent stimulation effective in pain management? An additional perspective. American Journal of Pain Management, 11(2):62-66, 2001.

Cost

The Alpha-Stim is also a lot more cost effective than almost any other treatment for pain and stress-related disorders. Once the device is purchased it costs very little to use. Most drugs cost more than an Alpha-Stim after just a few months. Because of the reduced amount of time it is used, and the inexpensive felt electrodes used with the probes and ear clip electrodes, Alpha-Stim devices are even less expensive than the cheapest TENS unit over time.

Safety

With the recent publicity about the dangerous side effects of many prescription medications, patients are more concerned than ever about the risks they take when they seek help for their pain or mood disorders. Alpha-Stim technology is not only safer than any drug, but it is even safer than most other devices because it only uses microamperes (uA; millionths of an ampere) of electricity. To put this into perspective, a device producing a maximum output of 600 uA, like the Alpha-Stim, uses about 1,000 times less current than a typical TENS device, and is limited to about 11,000 times less power than a 60-watt light bulb. Some people don't even feel this amount of electricity.

There are minimal self-limiting side effects. Only one out of 506 people will experience a mild headache, and one out of 910 will have a skin reaction at the electrode site. Usually a minor self-limiting reddening of the skin. There are no other significant side effects reported in over 125 research studies, or in 27 years of clinical and home use. 

When you invest in Alpha-Stim technology, whether a patient for a medical problem, or a medical professional who wishes to utilize an effective approach to pain and stress management, you are investing in more than a medical device. You are investing in technology backed by decades of research and a company which supports its products and its customers.

Conclusion

Alpha-Stim technology has been developed and used over a long period. It is backed by more independent research than any other device in its class and has a high efficacy. It has been approved for use by regulatory authorities worldwide for stress related illnesses, anxiety, insomnia and pain relief.  It is cost- effective and there have been no reports of significant side effects from any Alpha-Stim device.

---------------------------------------------

Dr. Daniel L. Kirsch

The Alpha-Stim Medical Devices were developed by neurobiologist Dr. Daniel L. Kirsch and consultant engineers. Dr. Kirsch has been a leading pioneer in the field of electromedicine since 1972. He is a Fellow of the American Institute of Stress, a Diplomat of the American Academy of Pain Management and a Fellow of the Clinical Electromedical Research Academy. Dr. Kirsch has served as Clinical Director of the Centre for Pain and Stress-Related Disorders at Columbia-Presbyterian Medical Centre in New York City and the Sports Medicine Group in Santa Monica, California. He lectures frequently to physicians worldwide on pain and stress management. 

 

Dr Kirsch is the recipient of numerous awards including most recently, The American Academy of Pain Management Richard S. Weiner Pain Education Award 2008, and the American Institute of Stress Award for Distinction and Innovation 2008.

 

 

Use always as directed, always read the label. If symptoms persist contact a health care professional

ARTG No. 137247

 

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