#2 Neuromodulation Therapy for Cluster and Migraine Headaches

Overview

Headaches rank just after the common cold as the ailment that bothers most Americans, and for 50 million of them the headaches are so severe that they consult a doctor.

Cluster headaches, which affect about three of every thousand American adults, are the most painful of all. This headache gets its name because it comes without warning in a cyclical pattern or cluster, typically occurring at the same time of day or night, and continuing like clockwork day after day for weeks or months. There is no known cause for these headaches or any effective therapy. Some people have been known to bang their heads against a wall to relieve the unremitting pain. Nicknamed the “suicide headache” because doctors feared patients would take their lives, in order to end the torment, some people resort to more drastic measures to get relief.

Tens of millions of Americans suffer from migraine headaches. The pain can range from mild to severe, and last for just an hour to a day or two. By the time migraine pain reaches higher levels, sufferers are unable to go about normal everyday activities. According to the National Headache Foundation, migraine headaches affect approximately 28 million adults in the United States, and American employers lose close to $13 billion annually due to 113 million lost workdays because of migraine complaints. While there is no cure for migraines, they can be managed with various medications.

The sphenopalatine ganglion (SPG) nerve bundle is located deep in the face, behind the bridge of the nose. Since the application of cocaine or alcohol to the SPG was first described in the medical journals more than 100 years ago as effective headache therapy, the SPG bundle has been a specific target for the treatment of severe headache pain over the years: When lidocaine and other medications are applied to the area, it creates a nerve block. While headache relief is often good, it is short lived and repeat procedures are needed. This is not easy, however, due to the location of the nerve bundle.

Rather than relying on a variety of preventive and abortive medications or other strategies such as inhaling pure oxygen, the most common treatments for migraine and cluster headaches, respectively, there is now a novel solution that can reduce their frequency and severity without medication.

American researchers have invented an on-demand patient-controlled stimulator for the SPG nerve bundle. This miniaturized implantable neurostimulator, the size of an almond, is placed through a minimally invasive surgical incision in the upper gum above the second molar, and held in place there. The lead tip of the implant is placed at the SPG nerve bundle on the side of the face where headache pain is typically experienced by the patient.

Whenever a patient feels a headache coming on, a remote control device is placed on the cheek and it delivers as-needed stimulation to the SPG, blocking the headache pain in about five to 10 minutes. Once the headache is treated, the device is moved away from the cheek, which turns off the stimulation therapy.

In European testing, 68% of patients responded to neuromodulation therapy, achieving cluster attack pain relief, reduction in attack frequency, or both. The therapy also improved headache disability in 64% and quality of life in 75% of the patients. Now already approved and available in Europe for the treatment of cluster headaches, in the United States the Food and Drug Administration has granted investigational use of the neurostimulation system for cluster headache. International multi-center randomized clinical trials are currently ongoing for migraine treatment.

Where Are They Now

After a two year follow up, 73% patients who had received this implant reported an improvement in quality of life, an important success for these patients who were severely affected with cluster and migraine headaches with previously no other efficacious treatment options. Data from a study released in 2016 stated patients that integrated neuromodulation therapy into the standard of care had a significant and sustained reduction in cluster headache attack frequency. Data released in 2017 from three clinical trials using non-invasive neuromodulation medical devices continue to support the therapy.

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