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Clinical Trials & Results:
Migraine
Headache, Hormonal Headache (PMS),
Smoking Cessation
Migraine Headache, Hormonal Headache (PMS)
More than 45 million Americans suffer from chronic recurring
headaches, and 28 million suffer from migraine headaches. Migraine
headaches affect 13% of the population, or 1 in every
4 American household. Seventy percent (70%)
of all migraineurs are women. In addition, more than 20%
of all young people in the United States experience chronic headaches.
It is estimated that 9% of all American school-aged children
experience migraine that severely disrupts their school activities.
In the first double-blind placebo clinical trial of the NET-1 for
treatment of chronic migraine headaches and premenstrual syndrome,
72% of the volunteer subjects who were randomly assigned active
devices, reported significant reduction in the frequency and intensity
of their headaches and the associated symptoms. As the result, there
were major reduction of the use of prescription and over-the-counter
medications, and visits to clinics or hospital emergency rooms. The
study found that 43% of the subjects who were randomly assigned
placebo devices reported similar effects.
Two other clinical studies indicated responses ranging from 35%
active devices vs. 18% placebo. A separate study with no placebo
devices resulted in 56% positive responses. The study design
followed the guidelines established by the International Headache
Society (IHS). Each study lasted for three months.
During the course of our clinical studies of migraine headaches, we
observed that many subjects who suffer from debilitating migraines
are also dependent on narcotics. This dependency on narcotics for
pain relief is a major concern for many migraine sufferers that has
been ignored. Since the NET-1000 device is also effective for addiction
therapy, the patients can treat both conditions at the same time.
Smoking Cessation
Cigarette smoking imposes tremendous costs on society both in terms
of negative health consequences and economic losses. There are 48
million smokers in the U.S. Each year, approximately 440,000 Americans
die of smoking-related diseases. Chronic smoking reduces longevity
by an average of 13.2 years among male smokers and 14.5 years among
female smokers (CDC 2002). Overall, smoking costs US$75.5 billion
in excessive medical expenses and US$81.9 billion in mortality-related
productivity losses (CDC 2002). Current FDA approved methods of smoking
cessation have had at best, 13-26% success rate. We believe
that NET-1000 device offers the best chance of success to those who
have not responded well to smoking cessation products or programs.
There are also individuals who cannot physiologically tolerate nicotine
substitutes, prescribed medications, or find them to be ineffective.
A total of 10 clinical trials were conducted at three different
sites with volunteer subjects. Dr. James R. Wilson at the University
of Colorado, Institute for Behavioral Genetics, conducted majority
of the clinical trials. The NET-1 device was found to be 60%
effective in treating nicotine addiction compared to 15% placebo
effects. To test the effectiveness of the device, no adjunctive therapy
was employed in the clinical trials.
The primary stipulation for participating in the clinical trials was
that all participants must have tried and failed using the FDA approved
products and other available techniques such as nicotine gum, nicotine
patches, nicotine nasal spray, Zyban, acupuncture, hypnosis, behavior
modification, group therapy, etc. before they were accepted into the
NET-1 clinical trials. |
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