When to consider neuromodulation devices for migraine.
Cefaly vs. Nerivio, Nerivio vs. GammaCore, Cefaly vs. GammaCore, Nerivio vs. SAVI Dual (formerly Spring TMS and sTMS mini), Cefaly vs. SAVI Dual, GammaCore vs. SAVI Dual, Relivion vs. Cefaly, Relivion vs. Nerivio? These neuromodulation devices provide non-pill options for both the acute and preventive treatment of migraine.
It’s fantastic to have so many new non-medication neuromodulation options for migraine treatment, but how do you choose which one to use? Which neuromodulation device is best for YOU? These are common questions that patients and healthcare providers have about migraine neuromodulation devices.
Many patients do not respond to conventional migraine abortive (as needed) and preventive medications (taken daily to prevent migraines). Others may not tolerate them because of side effects, do not like taking medications, or cannot take them due to medical contraindications such as pregnancy or heart disease.
Standard migraine abortive options are discussed here, and include the triptans, the gepants (Nurtec ODT, Ubrelvy) and the ditans (Reyvow).
Preventive migraine treatments include a daily pill, a monthly/quarterly treatment such as CGRP monoclonal antibodies (Aimovig, Ajovy, Emgality, Vyepti), gepants, and Botox. Other conservative preventive treatment options include herbal and natural supplements and vitamins, yoga and meditation, and acupuncture and acupressure.
Luckily, there have been several effective migraine neuromodulation devices which have entered the market over the last few years. These non-invasive neuromodulation devices open up new migraine treatment options for those in difficult patient populations such as pregnancy or other medical issues who can not use many of the typical options, or just don’t tolerate those treatments.
But do they really work? Is one better than the other? Do they hurt? Are they used for abortive or preventive treatment? Are they expensive? Does insurance cover them? How do they compare, and is one best for you? This blog will address all of these questions.
What are the currently available neuromodulation devices for migraine and cluster headache?
These devices include Single-Pulse Transcranial Magnetic Stimulation (sTMS) (SAVI Dual, formerly SpringTMS and sTMS mini), external trigeminal nerve stimulation (eTNS) (Cefaly), noninvasive Vagus Nerve Stimulation (nVNS) (GammaCore), wireless remote electrical neuromodulation (REN) (Nerivio), and most recently, external combined occipital and trigeminal neurostimulation (eCOT-NS) (Relivion MG). We’ll discuss these devices in the order in which they became available and FDA cleared below.
The table at the bottom of this article is a summary of comparison data between devices gathered from published studies and directly from the companies as well (check back periodically as updates are in progress). It’s important to keep in mind that the data in this table are not from head to head studies between devices. Comparative analysis across efficacy studies with different devices had different patient populations, treatment and sham (placebo) protocols, with separate and variable study designs.
The results of those studies is what is reflected in the table and discussion below, but it is certainly NOT a direct comparison between devices. Pricing and intermittent promotional specials can be found on each device’s website and some of these are discussed below. Sometimes the long-term costs equal out or can even be less than the cumulative cost of many medications and treatments used abortively and preventively.
SINGLE-PULSE TRANSCRANIAL MAGNETIC STIMULATION (SAVI Dual, formerly Spring TMS and sTMS mini)
What is SAVI Dual (formerly Spring TMS and sTMS Mini)?
Transcranial magnetic stimulation (TMS) treatments are discussed in much greater detail here, and there are different types. The first device which was FDA cleared was the Single-Pulse Transcranial Magnetic Stimulation (sTMS), made by the company eNeura. It was initially FDA cleared for the acute treatment of episodic migraine with aura in adults in December 2013.
It then received FDA clearance for both acute and preventive treatment of migraine in adults in 2017. This clearance was then expanded to the acute and preventive treatment of migraine in children 12 years of age and older in February 2019.
Prior models included the Spring TMS and sTMS mini. The newest model available, SAVI Dual, is currently the only FDA cleared device for both the acute and preventive treatment of migraine in adults and children 12 years of age or older.
So what is SAVI Dual vs. Spring TMS vs. sTMS mini? Basically, SAVI Dual has all the benefits of sTMS treatments that prior models offered, with the benefit of automated treatment compliance and monitoring through wireless smart technology.
eNeura filed for Chapter 7 bankruptcy on 8/7/20, and the company was shut down from August 2020-February 2021. However, the company has luckily been revived and is now functioning again as of February 2021. The company has been focusing on insurance coverage for the SAVI Dual, and they have obtained one contract for coverage so far.
How does SAVI Dual work?
The user holds the device against the back of the head, and presses a button to release a very short magnetic pulse at the onset of aura or a migraine attack with or without aura. The magnetic pulse delivers a fluctuating magnetic field which induces a mild electric current through the skull and onto the surface of the occipital cortex (visual cortex) of the back part of the brain.
This magnetic pulse modifies the electrical excitability and hyperactivity of the cortical neurons to block or prevent the onset of a migraine from evolving to a full-blown migraine. The device stops cortical spreading depression, which is suspected to be the basis of migraine aura in the occipital cortex. It is also suspected to interfere with thalamocortical pain pathways that are normally activated during a migraine.
The company offers a 90-day money back guarantee, and it is typically rented in 3-month increments.
How is SAVI Dual used?
Acute migraine treatment consists of 3 sequential pulses (early) at the onset of a migraine (aura or pain). Then wait 15 minutes. If needed, treat with an additional 3 pulses. Then wait another 15 minutes. If needed, treat with an additional 3 pulses. Studies reported that 39% of patients were pain free at 2 hours.
Prevention treatment consists of 4 pulses twice daily. This is performed by giving 2 consecutive pulses, waiting 15 minutes, and then repeating 2 consecutive pulses. Studies reported that 46% of patients had a greater than 50% reduction in monthly headache days and averaged approximately 3 less migraine days per month.
The FDA claim does not state a maximum pulse usage, and the company encourages patients to use as many pulses as needed to in order to achieve maximum relief. That’s another benefit of SAVI Dual; use it as much and as often as needed.
What are the side effects of SAVI Dual?
The most common side effects reported in trials were mild and brief light-headedness/dizziness, tingling over the back of the head where treatment is performed, brief tinnitus (ringing in ears), nausea, and muscle spasm. Sometimes a tapping sensation on the scalp is described.
Caution should be used with any kind of metal implants, similar to an MRI. If you have MRI safe implants of any kind in the head or neck, sTMS is felt to be safe to use. It is suggested that patients with implants affected by a magnetic field should not use this device. Examples of such implants include aneurysm clips or coils, cochlear implants, cerebral spinal fluid shunts, bullets or pellets lodged in the head or upper body, metal plates, screws, staples or sutures in skull, neck, shoulders, arms or hands, and facial tattoos with metallic ink. Dental implants, fillings or other dental appliances are okay to use the device.
Patients with seizures aren’t an absolute contraindication for sTMS treatment, but caution is advised. The FDA listed seizure history as a “warning” in the FDA clearance label.
You should not use this device if you have a cardiac pacemaker, vagus stimulator (VNS) or other implanted neurostimulator, implanted cardioverter defibrillator (ICD) or any implanted medical device that stimulates the body or uses any signal from the body.
How do I get the SAVI Dual device?
The only thing needed to start the process is the company’s prescription form for the patient (found on their website at www.eneura.com). The SAVI can be prescribed by any type of provider, not just neurologists or headache specialists. All enrollment information (including payment options) is sent directly to the patient via email once the prescription is received. There is no obligation to the patient to enroll/fill the prescription. The complete prescription form just gives the company the opportunity to outreach to the patient and provide them with any information they need, including clinical advice. The patient’s full email address and phone number must be included on the form. Contact information for the prescriber’s office is desirable as well, as indicated on the prescription form.
-$350/month (with initial 3 month commitment) and a one time $50 shipping fee (the initial 3 months can be paid in monthly installments).
-If paid in monthly installments with a credit card on file, the 12th month is free!
The company continues to work with payers on coverage. They are an out of network product for many payers. Therefore, the patient pays up front for the device. They can then submit for any potential reimbursement with their insurance company. They have had some recent coverage success in the private sector, so hopefully we will see coverages continue to expand.
What is Cefaly?
Cefaly was the next neuromodulation migraine treatment device that became available. It is made by Cefaly Technology. It was FDA cleared for the prophylactic (preventive) treatment of migraine in adults in March 2014, and acute treatment of episodic migraines in adults in November 2017. The Cefaly Dual device is the most recent model, and has settings for both acute and preventive migraine treatment. The company offers a 60-day money-back guarantee.
How does Cefaly work?
Cefaly works by external trigeminal nerve stimulation (eTNS), similar to a TENS unit mechanism. It works by neurostimulation of the trigeminal nerve branches in the forehead to disrupt the electrical circuitry involved in a migraine attack.
How is Cefaly used?
Acute migraine treatment consists of a 1-hour session. It may be repeated for a second 60-minute session if the migraine pain is not relieved within two hours, or if another migraine attack occurs. Studies reported that at 1 hour, 32% were pain free and 79% had significant pain relief. At 2 hours, 17% were pain free and 65% significant pain relief.
Migraine prevention consists of a nightly 20-minute session. Studies reported a 29.7% decrease in migraine attacks, and 38.1% of patients received at least 50% decrease in migraine attacks.
How much is Cefaly?
As of 10/13/20, the Cefaly Dual neuromodulation device became the first FDA-approved trigeminal nerve stimulator for migraine treatment available without a prescription and can now be purchased over-the-counter.
The Cefaly Dual kit includes the Cefaly device, 1 electrode (good for 20 uses), power adapter, charging cable, and storage case. It normally retails for $499. Three packs of electrodes are $25, or by a cost-saving subscription service. However, the best way to get cost information is to check the Cefaly website as these prices sometimes change and promotions may vary.
What are the side effects of Cefaly?
Cefaly treatment is often described as a mild buzzing and pressure sensation. It should be avoided in patients with implanted metallic or electronic devices in the head, or who have a cardiac pacemaker or implanted or wearable defibrillator.
VAGUS NERVE STIMULATOR (GAMMACORE)
What is GammaCore?
Noninvasive Vagal Nerve Stimulation (nVNS) is made possible by a hand-held device called GammaCore, from the company ElectroCore. The most recent model is called GammaCore Sapphire.
GammaCore was initially FDA cleared for the acute treatment of episodic cluster headache in adults in April 2017. This was followed by the acute treatment of migraine in January 2018, cluster headache prevention in November 2018, and migraine prevention in March 2020. It was the first and remains the only device which is FDA-cleared for the prevention of cluster headache.
How does GammaCore work?
Gammacore is placed over the vagus nerve on the side of the neck of the headache, just below the angle of the jaw where the pulse of the carotid is felt in the neck. It is suspected that the device works by suppressing cortical spreading depression (a central process in migraine and aura formation). It also blocks and modulates the thalamocortical, trigeminovascular and trigeminocervical pain pathways that are normally activated during a migraine.
How is GammaCore used for migraine and how effective is GammaCore for migraine?
Acute migraine treatment consists of 2 two-minute stimulations. If the pain remains 20 minutes after the start of the initial treatment, 2 more two-minute stimulations are given. Two more two-minute stimulations may be applied if the pain remains 2 hours after the start of the initial treatment.
Studies showed significant pain relief in as soon as 30 minutes, and reported that at 1 hour, 21% were pain free and 35.8% had significant pain relief. At 2 hours, 30.4% were pain free and 40.8% significant pain relief. GammaCore reduced pain intensity over 3x greater than sham (fake device) at 60 minutes and over 6x greater at 120 minutes, and reduced the need for other rescue medications.
Preventive migraine treatment is done by giving 3 treatments daily (morning, mid-day, and night) consisting of two consecutive 2-minute stimulations. Studies showed a 29% reduction in migraine days per month when used preventively, although this number was even higher in those with aura at a 35.8% decrease. Overall, 33.6% of patients received at least a 50% decrease in migraine frequency.
How is GammaCore used for cluster headache and how effective is GammaCore for cluster headache?
Acute cluster headache treatment is done by giving 3 two-minute stimulations. After completing the 3rd stimulation, the user waits 3 minutes. If pain remains, 3 more two-minute stimulations can be applied. You may treat up to 4 attacks (8 treatments) for a total of 24 stimulations per day.
Significantly more episodic cluster attacks treated with GammaCore were pain-free at 15 minutes vs those treated with sham (47.5% vs 6.2%). Combined study data showed that significantly more (over 2-4x greater response) episodic cluster headache patients responded (no pain or mild pain) to GammaCore at 15 minutes for 50% or more of all treated attacks vs those receiving sham (34.2-64.3% vs 14.9-15.4%). At 15 minutes, there were also significant reductions in pain duration and intensity with GammaCore compared to sham.
Preventative cluster treatment is done by giving 2 treatments (morning and night) consisting of 3 two-minute stimulations. Weekly attack frequency decreased by 40% from baseline when GammaCore was added to standard of care therapy. There was a 57% decrease in the frequency of acute medication use when GammaCore was added.
What are the side effects of GammaCore?
GammaCore treatment is often described as a deep vibration. GammaCore should not be used with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device. It should be avoided in patients who have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck, are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).
What is Nerivio?
The Nerivio device is made by the company Theranica. It is a wireless remote electrical neuromodulation (REN) device wearable for the acute treatment of migraine applied to the upper-arm. It was FDA-cleared for the acute treatment of episodic migraine in adults in May 2019. In October 2020, FDA clearance was extended to acute treatment of migraine in chronic migraine patients as well. In January 2021, Nerivio received FDA clearance for acute migraine treatment for episodic or chronic migraine in patients 12 years and older. There are ongoing studies for migraine prevention as well, so stay tuned.
How does Nerivio work?
Each device provides 12 treatments. When the device is used up, it is recycled and a new refill device is sent. It is the most economical option on the market. Costs can often be similar to monthly triptan prescription costs.
The device works through an app downloaded on your smartphone which controls the strength and treatments. The device itself is an arm band that easily straps around the upper arm, and was recognized in TIME Magazine’s annual list of the 100 Best Inventions in 2019.
It delivers electronic pulses into the skin to generate a proprietary “Conditioned Pain Modulation” response which helps to abort the effects of a migraine in patients with or without aura. Nerivio stimulates specific sensory nerves of the upper arm which normally sense pain. The stimulation from the device is not strong enough to actually trigger pain for the user, but the signal still travels to the brainstem, as it normally would. From here, it interferes and blocks the ongoing activated electrical circuitry of the migraine, and helps to abort it.
Many think this is basically a TENS unit, but it is certainly not. It has a proprietary stimulation signal which targets specific pain transmitting nerve fibers that disrupts the electrical activity of a migraine centrally from a remote location peripherally (on the arm).
How well does Nerivio work?
The device is applied within 60 minutes (preferably at onset) of a migraine headache or migraine aura and stimulation is performed for 45 minutes. It is described as a vibrating sensation. Studies showed that 66.7% of patients had significant pain relief at 2 hours, and 37.4% of patients achieved complete pain relief at 2 hours. Furthermore, 89.7% of patients studied avoided having to take other abortive medications when treating with Nerivio.
In the study leading to Nerivio treatment extension to adolescents 12 years and older in January 2021, 71% of patients had pain relief by 2 hours after Nerivio treatment, while 35% received complete pain relief. Pain relief and pain freedom were sustained for 24 hours in 90% of cases.
What are the side effects of Nerivio?
Side effects may include a temporary sensation of warmth, local tingling, numbness in the arm, pain in the arm, or redness of the skin, although 96.4% of patients studied did not report any device related adverse events.
It is recommended to avoid in congestive heart failure, severe cardiac or cerebrovascular disease and uncontrolled epilepsy. It should not be used with certain medical devices such as a pacemaker or hearing aid implant. Using Nerivio with other implantable medical devices could potentially cause electric shock, electrical interference, or other injury. So it should not be used near any metallic implants.
How much does Nerivio cost?
In October 2020, Nerivio became the first neuromodulation device to receive a pharmacy/medical benefit. It is available for $10 on the initial prescription for anyone with any form of medical or pharmaceutical insurance, including government insured patients such as Medicare and Medicaid! Commercially insured patients may have their Co-pay reduced to $0 on future refills, while government insured patients will pay $99 for refills. No patient ever pays more than $99 for a refill, and most will hopefully pay $0 on refills. The company has started to obtain limited commercial insurance coverages, which is a first for the neuromodulation devices.
Theranica launched a reimbursement hub called Nerivio Express in October 2020. By working with insurance companies, Nerivio Express is able to provide Nerivio for a co-pay as little as $10, dependent on the patient’s insurance. Each Nerivio device provides 12 treatments of 45 minutes duration.
What is Relivion?
In March 2021, the company Neurolief received FDA clearance for its Relivion MG external combined occipital and trigeminal neurostimulation system (eCOT-NS) neuromodulation device for acute migraine treatment. Notably, it has also received recognition as an FDA breakthrough device for the treatment of major depression.
The Relivion MG device transmits treatment information to a patient app, where the smart technology can learn about your migraine. The Relivion MG system connects information about your migraine, treatments, lifestyle and environment to your doctor via a secure cloud database to analyze data and share insights with your doctor to help optimize care.
How does Relivion work?
This is a non-invasive, self-administered neuromodulation device used for the acute treatment of migraine attacks. The device is worn as a headset and simultaneously stimulates 6 peripheral nerve branches of the occipital (2 electrodes in the back of the head, 1 on each side over the greater occipital nerves) and trigeminal nerves (4 electrodes in the forehead, 2 on each side over the supraorbital and supratrochlear nerves).
Relivion MG is the first and only noninvasive neuromodulation device that stimulates the 2 main peripheral nerve pathways which are felt to influence migraine (trigeminal nerve pathway and occipital nerve pathway). This spread out stimulation allows for more stimulation to be delivered comfortably.
How well does Relivion work?
This FDA clearance was based on the results of a multicenter, prospective, randomized, double-blind, placebo-controlled clinical study (“RIME” study) involving 131 adult patients who treated migraine with or without aura with an hour-long acute treatment. The RIME US Pivotal Study met all its endpoints with statistical significance. The pivotal trial has been submitted along with another RCT, but neither is officially published yet. In the trial, the significant data points were:
-Complete pain freedom at 2 hours: 46% of patients in Relivion group vs. 11.8% of patients in the sham (placebo) group. 78% of patients who became pain free at 2 hours had sustained pain freedom at 24 hours. So it appears to provide a highly effective treatment for delivering pain freedom at two hours and sustained pain freedom at 24 hours.
-Freedom from most bothersome symptom (MBS) (nausea, photophobia, or phonophobia) at 2 hours: 75% of patients in Relivion group vs. 47% of patients in the sham group. Relivion MG is the first noninvasive neuromodulation technology to be statistically positive for both pain freedom and most bothersome symptom (MBS) freedom at 2 hours.
-76% of patients achieved headache relief at 2 hours.
What are the side effects of Relivion?
In the RIME Study, a total of 12 adverse events were reported. All events were mild to moderate (ie scalp numbness, itching, skin irritation and redness) and were anticipated and self-resolved.
|1-hour migraine pain free||N/A||32% (13% sham)||21% (sham 10%)||N/A|
|1-hour migraine pain relief||N/A||79% (39% sham)||35.8% (sham 24.4%)||N/A|
|2-hour migraine pain free||39% (sham 22%)||17% (sham 7%)||30.4% (sham 19.7%)||37.4% (18.4% sham)|
|2-hour migraine pain relief||N/A||65% (sham 52%)||40.8% (sham 27.6%)||66.7% (38.8% sham)|
|Migraine preventive relief||46% had > 50% decrease in monthly HA days (20% “statistically derived” placebo) and averaged 3 less migraine days/month|
29.7% decrease (sham 4.9%)
38.1% received at least 50% decrease in migraines (sham 12.12%)
29% decrease (sham 18%)
35.8% decrease in patients with aura
33.6% received at least 50% decrease in migraines (sham 23.4%)
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Neuromodulation is a type of therapy that involves electrical stimulation for the treatment of migraine. Neuromodulation acts directly on the nervous system within the targeted area. For migraines and cluster headaches, there are a few types of neuromodulatory devices available, including Nerivio, Cefaly, Relivion, Gammacore, and Spring TMS.
These devices have all been thoroughly and rigorously tested. Generally speaking, most patients will be able to safely use a neuromodulatory device for their cluster headaches or migraines. There are some people who should avoid using this type of technology, including people who have: metallic implants, pacemaker devices, aneurysm clips or coils, wearable defibrillators, and other medical devices. Your doctor will avoid prescribing neuromodulatory devices if they are not a good fit for this reason.
Neuromodulatory devices are a good fit for patients who are unable to tolerate some of the standard medications for migraines, or may not be able to take them because of medical contraindications. For example, people with heart and blood pressure issues might not be a good fit for triptans. In this case, they might be a good fit for a neuromodulatory device. On other occasions, the standard headache and migraine medications might not work effectively for patients. Neuromodulatory devices are prescribed when traditional prescription medications are not a good fit for the patient or simply won’t work.
Each different type of neuromodulatory device will have a “best fit” scenario based upon your headaches or migraines and the therapy that your doctor feels that you need. All of the different types of devices are approved and good for acute migraines. Some of them are also approved for migraine prevention. GammaCore is the best for acute cluster headaches, and the only device approved for cluster headaches. It is also used for migraine. If you are looking for a device that is affordable and highly effective, take a look at Nerivio if you have insurance or Medicaid/Medicare. This was the first device to receive an insurance benefit and will cost an initial copay of $10.
In terms of the length of treatment for using a neuromodulatory device, there isn’t a set length of time. Generally speaking, the patient will use the device for as long as treatment is effective or needed. However, each device works for different lengths of time:
- Nerivio: Each device is good for 12 different treatments.
- Cefaly: With Cefaly, the electrodes you will use will be good for about 20 sessions.
- Relivion: Each pack of six electrodes can be used for one treatment.
- Gammacore: This device uses an RFID treatment card which will let you use the device for 31 days.
- eNeura: The SpringTMS and sTMS mini are generally used by patients over an increment of 90 days. As with the Gammacore device, you will have a prescription, but in this instance, the prescription card is a SIM card.