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Clinical Trials And Results

Results for Migraine Headache and Hormonal Migraine (PMS)

Migraine Headaches

More than 45 million Americans suffer from chronic recurring headaches, and 36 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, an earlier version of the Net-1000, 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 study subjects who were randomly assigned placebo devices reported similar effects. All the study participants had to submit a letter from their physician or neurologist to confirm migraine diagnosis prior to participation in the studies.

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.

Click here to see study results in case 1.

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Smoking Cessation

Cigarette smoking imposes tremendous costs on society both in terms of negative health consequences and economic losses. There are 45 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 or have dangerous side effects.

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, Chantic, acupuncture, hypnosis, behavior modification, group therapy, etc. before they were accepted into the NET-1 clinical trials.

Click here to see study results in case 1.

Click here to see study results in case 2.

Click here to see clinical trials of smoking cessation.

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Baxter Black, a local large animal veterinarian, former CSU professor and NPR contributor actually wrote a satirical piece on this conundrum.