Current Neuromodulation Devices

March 21, 2018
Jim Carleton

 

With all of the anticipation of CGRP blockers, the sober news is that they will not be a savior for all migraine sufferers. First, like all pharmaceutical agents, they will not work for all migraine sufferers. Secondly, CGRP blockers are expensive (the current guess is that they will cost roughly $1000 a month). That is a big bill for insurance companies and therefore we do not know how difficult it will be to qualify for this therapy.

Knowing this, neuromodulation - the use of electrical or chemical stimuli to change temporarily nerve function - offers a less expensive, low-risk alternative to conventional migraine therapies. There are now several noninvasive neuromodulation devices to treat acute, chronic and cluster headaches. They do not work for many people but they do not have significant problems with side effects. We will briefly review the three FDA cleared devices on the US market. It is worth noting that there is a distinction in the rigorous standards that the FDA applies to approval of pharmaceutical agents in contrast to the relatively relaxed standards applied to giving clearance of noninvasive medical devices. Unfortunately, none of these neuromodulators is covered by your health insurance. In some cases, you may be able appeal to your insurance company for reimbursement. Our discussion of these devices does not imply an endorsement of any one product. Whether or not neuromodulation may be suitable for you is a discussion you should have with a medical professional. A list of trained headache specialists by location is available on our website.

First on our list is the Cefaly Headband. Cefaly is an external trigeminal nerve stimulation device (essentially a TENS unit for the trigeminal nerve) for patients who suffer from chronic migraine with or without aura. It produces a noticeable tingling for across the forehead for about 10 minutes daily. It is FDA approved. Its cost is about $400, with a 60-day money back guarantee. A medical prescription is required and can be ordered through Cefaly website. Insurance companies do not cover it. About 50% of Cefaly users return their devices.

The second is a transcranial magnetic stimulator (TMS). The commercially available device is the sTMS mini. This device produces a brief magnetic charge that is applied on the surface of the back of the head. It can be used daily as a preventive device for all types of migraine headaches, but the FDA approved sTMS mini for acute treatment of migraine with aura.   It also requires a prescription. The manufacturer eNeura provides information about its use. sTMS mini is rented in three-month increments for $250 per month, but eNeura offers several discounts. For the most current pricing, contact the manufacturer's customer services at customercare@eNeura.com or (408) 245-6400.

The third device is the gammaCore which involves non-invasive vagus nerve stimulation (nVNS). ElectroCore utilizes a mild electrical stimulation to the vagus nerve that passes through the skin. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.There is a strong placebo effect with all neuromodulation but the maker of gammaCore, electroCore, is actively funding research into learning about the ideal electrical pulsing and how it functions. gammaCore has been released by the FDA for the acute treatment of pain associated with episodic cluster headache and migraine in adult patients. gammaCore for use in cluster headache and migraine has been priced comparable to the current standard of care. gammaCore costs $575/month for patients without insurance coverage or reimbursement. electroCore also offers co-pay assistance up to $100 a month for eligible patients.