Intractable migraine and other headache syndromes affect approximately 30 million Americans and many more millions worldwide.
Though there are many treatment protocols mainly designed around medication regimens, there are estimated to be at least 5% of these headache sufferers who do not respond in a meaningful way to medications and whose lives can be severely restricted to darkened, quiet rooms, heavy doses of narcotics, failed personal relationships and an overwhelming sense of hopelessness.
Subcutaneous neurostimulation into the regions of the scalp and forehead where the headache pains appears to begin has been pioneered by Richard L. Weiner, M.D., of DNS over the past 17 years as a relatively simple, minimally invasive technique for treating many of these intractable headache syndromes.
Using percutaneously placed uni or bilateral electrodes into the subcutaneous tissues, patients perceive a gentle tingling sensation under the skin blocking the painful areas from disorders including chronic daily transformed migraines, occipital neuralgia, cervicogenic headaches and deafferentation neuropathic pain.
The implanted devices are manufactured by three leading neurostimulation companies and are currently off-label for use in headaches. This means that the implants may be placed at the discretion of the physician but are not yet FDA-approved for headaches. Multicenter-, placebo-controlled studies are under way to obtain FDA approval for headache as an indication using standard products available for spinal cord and brain stimulation.
Not all patients are responders; however, long-term follow-up to date consistently reflects a 70% success rate with greater than 50% pain reduction and diminished use of medications, particularly narcotics.
Several hundred patients to date have been implanted utilizing the off-label equipment currently available. The emerging advances in stimulation technology hold significant promise for successful treatment of a number of localized pain syndromes.