Posts Tagged "cefaly"

Last updated on October 6th, 2021 at 05:55 pm

CEFALY vs. NERIVIO vs. GAMMACORE vs. SPRING TMS. NEUROMODULATORY DEVICES FOR MIGRAINE AND CLUSTER HEADACHE: WHAT ARE THE DIFFERENCES AND WHICH IS BEST?

@Neuralgroover

BACKGROUND

Cefaly vs. Nerivio, Nerivio vs. GammaCore, Cefaly vs. GammaCore, Nerivio vs. SpringTMS, Cefaly vs. SpringTMS, GammaCore vs. SpringTMS?  These are common questions that patients have about migraine neuromodulation devices. Many patients do not respond to conventional migraine abortive (as needed) and preventive medications (taken daily to prevent migraines), they do not tolerate them, do not like taking medications, or they cannot take them due to medical contraindications. 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) , and Botox.

Luckily, there have been several neuromodulatory devices for the treatment of migraine which have entered the market over the last few years. These non-invasive neuromodulation devices open up new migraine treatment options for those in these sensitive and difficult patient populations such as pregnancy or other medical issues who can not use many of the options noted above. These devices also avoid the complications of medication overuse headache (rebound headache) that is often an issue with using too much abortive migraine medication, as discussed in greater detail here. The neuromodulation devices provide new non-pill options for both the acute and preventive treatment of migraine.

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.

These devices include Single-Pulse Transcranial Magnetic Stimulation (sTMS) (SAVI, SpringTMS, sTMS mini), external trigeminal nerve stimulation (eTNS) (Cefaly), noninvasive Vagus Nerve Stimulation (nVNS) (GammaCore), and the most recent, wireless remote electrical neuromodulation (REN) (Nerivio). We’ll discuss these devices in the order in which they became available and FDA cleared. The table further down is a summary of comparison data between devices gathered from published studies and directly from the companies as well. It’s important to keep in mind that the data in this table are not from head to head studies between devices. Each of these devices had separate study designs (which were quite varied), and the results of those studies is what is reflected here, certainly not a direct comparison between devices. All devices require a prescription from your doctor. 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 (sTMS)

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, SAVI, 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. Since the device is used acutely and preventively, the FDA approved it for a maximum of 17 pulses per day.

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 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.

The most common side effects 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. 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. It is also 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.

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.

Unfortunately, eNeura filed for Chapter 7 bankruptcy on 8/7/20, so it is unclear what exactly the future holds for these sTMS devices.

CEFALY

Cefaly was the next neuromodulation migraine treatment device that became available, and is an external trigeminal nerve stimulation (eTNS) device (similar to a TENS unit mechanism). It is made by Cefaly Technology. It works by neurostimulation of the trigeminal nerve branches in the forehead. 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. 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.

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.

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.

VAGUS NERVE STIMULATOR (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. It was initially FDA cleared for the acute treatment of episodic cluster headache in adults in April 2017, 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 therapy which is FDA-cleared for the prevention of cluster headache This device is placed over the vagus nerve on the side of the neck, 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), and blocking and modulating the thalamocortical, trigeminovascular and trigeminocervical pain pathways that are normally activated during a 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.

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.

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).

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.

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 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).

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.

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.

In October 2020, Nerivio became the first neuromodulation device to receive a pharmacy/medical benefit.  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. 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.