Migraine headaches plague millions of people in the United States. Stewart et al. (1992) report that 18% of the women and 6% of the men in this country have migraines every year, and 3.4 million women have one or more disabling attacks a month. A variety of drugs are prescribed for the treatment and prevention of migraine attacks, and some, like sumatriptan, are quite effective. Nevertheless, high costs, side effects, contraindications, and variable results leave millions of people suffering and looking for alternatives. There is mounting evidence that pulsed electromagnetic fields have replicable clinical and physiological effects on factors relevant to the pathogenesis of migraine. An electromagnetic therapy could fill the need for a safe, non-pharmacological, innovative therapeutic approach to the prevention of migraines. The primary goal of this research is to evaluate the feasibility of such an approach in a sample of migraine sufferers. The criterion of effectiveness will be the percentage of subjects who experience at least a 50% reduction in the number of migraine attacks they experience. More specific objectives include identifying outcome measures for future research and generating hypotheses about the relative efficacy of two different treatment protocols.
Success in Phase I will lead to Phase II efforts to refine the pulsed electromagnetic signal delivery system, develop a comprehensive, empirically based treatment protocol, and obtain FDA approval to market the device and treatment system. The large number of migraine sufferers and the tremendous increase in consumer interest in alternative, non-drug therapies suggests that this will be a very successful commercial product.