sTMS is now approved for both adults and children as young as 12

The US Food and Drug Administration (FDA) just approved a new device for migraine prevention in teens: eNeura’s sTMS. This approval expands the therapeutic options for both adults and children 12 years of age and older.


The neuromodulation device was first approved in 2014 by the FDA for acute treatment of Migraine, and received the CE mark in Europe for acute and preventive treatment in 2014 and 2016, respectively. In 2017, the FDA approval expanded to include preventive use in adults.

With this new 2019 FDA clearance, the sTMS is now the only migraine product in the United States indicated both for the acute and prophylactic treatment of migraine in adults and children (12 years of age and older).

The FDA approval gives hope to patients who desperately need an alternative to their current marginally-effective treatments — and a non-drug option.

More than four million adolescents, 12 years of age and older, live with migraine in the US.

“The clearance of our sTMS product for both acute treatment and prevention of migraine in children as young as 12 years old is a breakthrough for migraine headache patients in the U.S.,” commented Dr. David K. Rosen, President and CEO of eNeura ( ).

“Until now, children have had very few safe and effective options for the treatment and prevention of migraine. Typically, migraine patients, including children, have had to use combinations of pharmaceutical products, each with potentially unpleasant and often disabling side-effects, to prevent headache and treat acute headache attacks,” he continued.

“sTMS is now labeled to address the entire spectrum of migraine with an easy-to-use device, that in multiple clinical studies, has proven to be safe and effective,” he concluded.


We tested the eNeura sTMS device in June at the 2017 American Headache Society Annual Scientific Conference in Boston, Massachusetts. A patient at the company’s booth gave himself a 2-second stimulation using the device on a day when he said he was “on the edge” of a migraine attack.

In case you missed it, Carl Cincinnato discussed the device in great depth during the 2017 Summit interview on neuromodulation therapy with Brian Grosberg, MD, Director of the Hartford HealthCare Headache Center and a Clinical Associate Professor of Neurology and Albert Einstein College of Medicine.

What’s it feel like?

The barely audible “snap” heard when the single pulse was emitted may leave you asking “Is that it?” Truly, it’s hard to imagine that such an innocuous, painless form of therapy could knock back the life-altering pain of a migraine attack.

In her 2016 review of eNeura’s device for Migraine Again, Teresa Powell characterized an earlier version of the device, then called SpringTMS, as “a big breakthrough for me, so far.” She observed “I don’t feel the magnetic pulse. The device does make a small popping sound to let you know the magnetic pulse was delivered.”

How does it work?

As Dr. Grosberg explained during the Migraine World Summit, “Transcranial magnetic stimulation occurs when a magnetic charge essentially is created near the scalp that leads to development of a small electrical current with the brain. If the electrical current that’s created is of sufficient size, duration, location, then that can change the firing pattern and excitability of nerve cells in the brain and either stop or prevent the migraine headache.”

How effective is it?


In a study presented by Amaal Starling, MD, at the April 2017 American Academy of Neurology conference, 132 subjects were observed for four months – one month of baseline headache frequency and three months of treatment with the sTMS device. The treatment protocol consisted of both preventive treatment (4 pulses twice daily) and acute treatment (3 pulses at 15 minute intervals repeated up to 3-times for each attack) ( ).

The results: an average of a 9.1 day reduction in headache frequency for people with 5-25 headache days per month. And 46% of patients reported at least a 50% reduction in headache attacks.

No serious adverse events were reported in this study, but less than 5% of patients mentioned minor side effects such as lightheadedness, tingling, and tinnitus.

Another 2015 study in the UK targeted people with medication overuse headache and found that 86% used less acute medication and 75% reported reduced pain severity. Also reported: fewer migraine days and shorter attacks ).

A smaller study focusing on adolescents over the age of 12 was published in Headache in 2018. The study included 12 patients and concluded that sTMS appears to be a feasible and well-tolerated non-pharmacological treatment for adolescents with Migraine. ( ).

How much will it cost?


According to eNeura’s website, the latest version of their device – the sTMS mini – costs $750 USD for three months. As of February 2019, they offer a new patient discount of $300 off the first rental period ( ).

Because the device is new and innovative, insurance companies are unlikely to include it in their formularies. Meaning: you can’t count on insurance to help with the bill. In a battle with insurance companies for more costly migraine care, patients must often undergo step therapy to demonstrate that less expensive preventive therapies like topiramate have failed to reduce the frequency or intensity of their attacks. Even then, coverage is not guaranteed.

The company seemingly recognizes some of the hurdles patients face getting coverage for new therapies. They offer “Access Consultants” to assist patients in reviewing coverage, exploring discount programs and assessing “funding options, such as HSA, FSA, HRAs, and Care Credit.”

Who is most likely to use it?

sTMS is available by prescription to patients ages 12 and up with a diagnosis of Migraine. The cost is likely to make it a better choice for those people whose frequent attacks are not responsive to other acute therapies, such as triptans, and preventive therapies, such as topiramate and beta-blockers.

People who prefer non-drug therapies, like pregnant women and those with heart problems for whom triptans are contraindicated, might also find sTMS to be a good option. Those with intractable or medication overuse headache responded well in clinical trials, and may reduce the impact of migraine upon their lives.


Finally, those with frequent migraine (more than 5 days a month, but less than 14) who cannot get insurance coverage for Botox may also be attracted to sTMS therapy.

Many may see eNeura’s sTMS device for migraine as a viable alternative to more painful Botox injections, currently only approved for chronic migraine patients who experience attacks more than 14 days per month. Only the sTMS device for migraine is approved for those with episodic attacks.

sTMS is now approved in the U.S., Europe, Australia and Singapore for both the acute treatment of migraine and migraine prevention

To determine if it’s right for you, talk to your doctor. You don’t need to see a headache specialist to get the device, but a prescription is required in the US.

Image: Graphic Stock

Updated March 1, 2019

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