Marshall C. Freeman, MD, FAHS
Migraine headache is one of the most common disorders in the world. In the United States alone it is estimated that over 36 million individuals have migraine. The World Health Organization (WHO) has rated migraine as one of the most disabling human conditions with similar single-day impairment as quadriplegia and active psychosis.
Many new treatments for migraine are currently available or are in clinical trials. As a Center of Excellence my practice has been actively involved in the development and study of these products. It is exciting to participate in the advances in this field and to see the potential impact on an incapacitating condition.
This article will review the newest migraine devices, some which are still in clinical development. The migraine devices discussed are non-medicinal products applied directly to the head or neck in order to reduce migraine headache events or migraine frequency. Some of the products are designed to abort an individual migraine headache, while others are used on a daily basis to reduce the total number of migraine headaches monthly.
Cefaly. The Cefaly device is an FDA-approved product for the prevention of episodic migraine. It is a battery-powered device administering electrical stimulations to the supraorbital nerves (located along or above the eyebrows). The recommended treatment duration is 20 minutes each day during which time the nerves receive electrical shocks via the preprogrammed device. If the stimulation is too uncomfortable initially it is possible to reduce the intensity. Over multiple exposures most individuals are able to tolerate the treatment.
The Cefaly device has a fair response rate. Individuals with between 2 and 14 migraines per month participated in the study. Over the course of three months, those subjects in the study getting the active treatment showed an overall reduction of approximately 2 fewer migraine days per month compared to no significant change in the group using the sham placebo device. The result of the patient satisfaction survey was also fair with 29.4% of subjects rating their experience as “very satisfied.”
The device is currently in its second model. The initial device was worn like a headband with two arms resting along the top of the ears. The updated model has a magnet which attaches to the forehead via adhesive electrodes. The updated model uses a small rechargeable battery and may be more user-friendly, especially for individuals who prefer to rest their heads on a pillow or cushion during the treatment period.
Like most of the devices described in this article, Cefaly is not covered by most insurance companies. Patients purchase the device directly from the manufacturer. The cost of the Cefaly device is $349 plus an additional $25 for a two to three month supply of electrodes.
Spring TMS. The Spring transcranial magnetic stimulation (TMS) is an FDA-approved device for the treatment of migraine headache with aura. This indication is somewhat limited, since the most common form of migraine is without aura. Only approximately 15% of individuals have an aura preceding their migraine. An aura is an electrical event occurring along the surface of the brain as part of the migraine disorder, often manifesting as a visual disturbance such as bright spots, dots, zig-zag lines, or a blind spot. Many patients will recognize that their migraine pain will soon develop because of the stereotypical nature of their own aura. Visual aura is the most common type, although some individuals may describe numbness and tingling of the hands or face and even weakness. The usual duration of an aura is between 5 minutes and 60 minutes.
Spring TMS is a relatively large device which is held with both hands. It is about the size of a large book with two handles. The device is held across the back of the head and administers a single electrical pulse which is believed to disrupt the electrical process of the aura. In one study using the device, 39% of individuals were pain free after two hours compared to only 22% using a sham device.
The Spring TMS is not covered by insurance. The device can only be rented from eNeura. The rates for rental are not published online and individuals should contact the company directly if interested.
gammaCore VNS. The gammaCore vagus nerve stimulation (VNS) is another novel product under study for the treatment of headache disorders. GammaCore VNS is being studied for acute treatment and preventive treatment of episodic migraine, chronic migraine, episodic cluster headache, and chronic cluster headache. Currently this product is not available in the United States and is not FDA-approved for any indication at this time.
Vagus nerve stimulation has been an effective treatment for depression and intractable epilepsy. Currently vagus nerve stimulation is accomplished using surgically implantable electrodes. The vagus nerve is a neurologically significant nerve which has been demonstrated to modulate pain thresholds. The nerve has many connections to the brain and brainstem. The gammaCore VNS device is a non-invasive and non-surgical stimulator placed along the throat where the vagus nerve may be accessed. The pattern of stimulation has varied depending upon the particular study.
The most promising study thus far with the gammaCore VNS device has been for the treatment of cluster headache. The ACT1 study evaluated subjects with both episodic and chronic cluster headache. During an active cluster headache attack subjects were directed to use the device for 60 seconds of stimulation a total of three times per headache (i.e. once every five minutes). A total of 34% of subjects in the episodic cluster headache group reported a reduction of cluster headache pain overall compared to 13% of subjects in the sham group. This is potentially a meaningful outcome for a headache disorder associated with crippling headache pain. Unfortunately, the study was not effective for those subjects with chronic cluster headache, which is the refractive form of the disorder and considered one of the most difficult headache conditions to treat. Early studies using gammaCore VNS for the treatment of migraine headache have also been unsuccessful.
TMN device. The Scion Neurostim Thermoneuromodulation (TMN) device is an experimental product used for the treatment of episodic migraine prevention. It is designed as a headset that is worn over both ears. The TMN device has an ear implant that fluctuates in temperature over the course of the program. The rationale is to use caloric vestibular stimulation to reduce the migraine burden. Early trials have demonstrated an improvement in migraine frequency with use of the device.
Marshall C. Freeman, MD, FAHS is the director of Headache Wellness Center (HWC) in Greensboro, NC. He is a board-certified neurologist in Adult Neurology, Neuromuscular Medicine, and Electrodiagnostic Medicine. He is a Fellow of the American Headache Society and holds specialty certification in Headache Medicine by the United Council of Neurological Subspecialties. HWC is the oldest and longest continuously operating headache specialty practice in North Carolina, serving the headache population since 1990. HWC is actively accepting new adult and pediatric patients. Please contact our office if you are interested in our current migraine studies. Visit www.HeadacheWellnessCenter.com or call 336-574-8000.