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The Essential Guide to Medical Devices for Migraine

March 24, 2021

When you’re seeking migraine relief, the first thing you try is often medication. There are dozens of options out there, from over-the-counter pain relievers to prescription pills and injections.

 

But migraine medication has its downsides, including medication overuse headache and potentially serious side effects. That’s when you begin to wonder about medical devices for migraine: How do they work? What do they feel like? Are they safe? Effective?

 

The appeal of these devices is that they can be used at home when needed, placing migraine control in your hands. Side effects are generally mild, although each device must be used exactly as instructed. Here’s a rundown of migraine medical devices — including CEFALY DUAL — to help you get a sense of what’s available. Most require a prescription; CEFALY is the first and only dual-purpose (rescue & preventative) device of its kind available over the counter, with no prescription required.

 

Please note that none of this information is intended as medical advice. If you’re searching for drug-free migraine relief, talk to your healthcare provider about the best options for you!

 

Migraine Device Acute or Preventative FDA-Cleared? Prescription Required? Accessories Required Where Is It Used?
CEFALY DUAL Both Yes No Gel Electrodes Forhead
gammaCore Sapphire Both Yes Yes - Rx refills required Conductive gel, prescription refill card Neck
Nerivio Acute Yes Yes - Rx refills required App; device must be replaced after 12 uses Upper arm
sTMS mini Both Yes Yes - Rx refills required Prescription SIM card Back of head

CEFALY® DUAL

 

CEFALY DUAL is an FDA-cleared medical device that uses mild electrical signals to stimulate and desensitize branches of the trigeminal nerve (the largest cranial nerve), treating the root cause of migraine pain. To use CEFALY, adhere a gel electrode to clean skin on the forehead, just above the eyebrows. The CEFALY DUAL attaches magnetically to the electrode.

 

The 60-minute ACUTE setting, used at the first sign of a migraine attack, is clinically proven to relieve migraine pain.[i] This setting uses high-frequency eTNS to block pain signals in the trigeminal nerve.

 

With compliant daily use, the 20-minute PREVENT setting is clinically proven to help reduce migraine severity and frequency.[ii] This setting uses low-frequency signals to gradually desensitize the trigeminal nerve.

  

CEFALY DUAL is the first and only FDA-cleared medical device of its kind for migraine treatment and prevention that’s available without a prescription. It’s designed to be: 

  • Easy to use, with simple set-up and a single treatment activation button
  • Safe — side effects have been demonstrated to be minor and fully reversible with cessation of device use
  • Durable, with a 3-year limited warranty

Acute or preventative? Both
Prescription required? No
FDA cleared? Yes

 

gammaCore SapphireTM

 

gammaCore Sapphire is a non-invasive vagus nerve stimulation (nVNS) device intended to treat migraine and cluster headaches. The gammaCore Sapphire is held against the neck and provides a mild electrical stimulation to the vagus nerve, which carries information to the central nervous system.

 

To prevent migraines, gammaCore Sapphire is used for three treatments every day (morning, mid-day and night), each consisting of two consecutive 2-minute stimulations. For acute migraine pain relief, two consecutive 2-minute stimulations are applied at the onset of pain or symptoms, with up to two additional treatments after that.[iii]

 

Conductive gel must be applied to the gammaCore device before a treatment. A “deep and strong vibration” is felt inside the neck during use, according to the manufacturer. [iv] The user can adjust the intensity. A special, prescription-only refill card, sent each month, is required to keep using your device.

 

Acute or preventative? Both

Prescription required for gammaCore? Yes, prescription must be obtained and refilled

FDA cleared? Yes

 

Nerivio®

 

Nerivio is a remote electrical neuromodulation (REN) device for acute migraine treatment. Controlled by a smartphone app, it’s placed on the upper arm at the onset of migraine symptoms and worn for 45 minutes. The accompanying app allows the user to start or stop a treatment, adjust the stimulation intensity, and monitor the treatment duration. Each Nerivio unit works for 12 treatments, and then the prescription is refilled with a new device.[v]

 

According to maker Theranica, the device activates the brain's native conditioned pain modulation mechanism to treat pain and associated migraine symptoms. The device “transmits transcutaneous electrical nerve stimulation by applying weak electrical pulses that invoke conditioned pain modulation (CPM) to inhibit migraine pain.”[vi]

 

Acute or preventative? Acute

Prescription required for Nerivio? Yes, prescription must be obtained and refilled

FDA cleared? Yes

 

sTMSTM mini Device

 

The sTMS mini device uses single-pulse transcranial magnetic stimulation (sTMS) technology. Used on the back of the head, it delivers a pulse of magnetic energy that creates a brief electrical current in the brain, intended to prevent or reduce the effects of migraine headaches.

 

For migraine prevention, the sTMS device is intended to be used twice per day — four pulses in a 15-minute session in the morning, and the same in the evening. Sessions of three sequential pulses, with 15-minute breaks in between, are used for acute migraine treatment.[vii] eNeura, the maker of the sTMS migraine device, filed for bankruptcy in 2020, and the long-term availability of the device is unclear.[viii]

 

Acute or preventative? Both

Prescription required? Yes, prescription must be obtained and refilled

FDA cleared? Yes

 

 

Are you curious about CEFALY DUAL? Learn more and try CEFALY risk-free for 60 days.

 

 

 

 

 

 

 


 

[i] Chou D. E. et al. Acute Migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial. Cephalalgia. 2018; Fig. 4, Page 10.

[ii] Jean Schoenen, Bart Vandersmissen, Sandrine Jeangette, Luc Herroelen, Michel Vandenheede, Pascale Gerard, Delphine Magis. PREMICE STUDY Migraine prevention with a supraorbital transcutaneous stimulator. A randomized controlled trial. Neurology Feb 2013, 80 (8) 697-704; DOI: 10.1212/WNL.0b013e3182825055

[iii] https://www.gammacore.com/wp-content/themes/gammacore-p2/pdf/gammacore-IFU.pdf

[iv] https://www.gammacore.com/about/using-gammacore/

[v] https://www.prnewswire.com/news-releases/fda-approves-theranicas-nerivio-for-acute-treatment-of-migraine-in-adolescents-301213967.html

[vi] https://theranica.com/wp-content/uploads/2020/10/LBL-NM-0014-1.9-Nerivio-User-Manual-1.9.pdf

[vii] http://webcache.googleusercontent.com/search?q=cache:Hd_yPWN6U0MJ:www.eneura.com/wp-content/uploads/2020/01/sTMS-mini-Physicians-Instructions-for-Use-LBL-0123-US-Rev-G.pdf+&cd=2&hl=en&ct=clnk&gl=us

[viii] https://migraine.com/eneura-stms/

 

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