Medical Device to Treat Migraines

A Single-Pulse Transcranial Magnetic Stimulator

Is There a New Way to Treat My Migraine?. Jamie Grill/Iconica/Getty Images

A migraine with aura is a debilitating, neurological condition that can negatively impact one's quality of life and daily functioning. Unfortunately, many migraineurs still suffer from these painful attacks, despite the plethora of therapies out there. If you are frustrated by your endlessly failing migraine treatments, you may find some solace in a recently approved migraine therapy that is quite unique.

A Novel Migraine Therapy

In December 2013, the U.S. Food and Drug Administration (FDA) approved the Cerena single-pulse Transcranial Magnetic Stimulator (sTMS) – a portable medical device used to alleviate pain caused by migraine with aura.

How does this device stop your migraine?

The primary cause of a migraine visual aura is thought to be a mechanism called cortical spreading depression or CSD. CSD is a wave of depressed nerve activity in the brain that sweeps across the cortex during a migraine. Preventive migraine medications like Topiramate (Topamax) have been found to suppress CSD in the brain. Similarly, this device is felt to disrupt CSD in the brain – thereby aborting one's migraine attack.

How do you use this device?

Within one hour after experiencing an aura, you hold the device against the back of your head and press a button. This releases a pulse of magnetic energy, stimulating the occipital lobe – which is located at the back of the brain.

The pulse of energy alters the way nerve cells in the brain fire or send signals, disrupting that wave of CSD.

The Study Behind the Device

The basis for the FDA's approval is a study in The Lancet Neurology. In this study, 201 individuals – who suffered from a migraine with aura – were randomized to undergo stimulation by sTMS versus a sham stimulation – a fake or nonfunctional device that was identical in appearance to the actual device.

These participants and study designers/testers were blinded to the randomization, meaning no one knew which device each migraineur was given. Participants were instructed to use the device for up to three attacks during a three-month period. Thirty-seven of the participants did not end up using the device and were excluded.

Results showed that two hours after treatment, the migraineurs using the sTMS (i.e the real device) had significantly more relief than those who used the sham device. Additionally, the participants were more likely to be pain-free 24 hours after use of the sTMS than those with the sham device. This also held true 48 hours after treatment.

In addition, the participants reported their head pain after their aura as mild, moderate or severe. The migraineurs who reported moderate or severe head pain and used the actual device had more relief of migraine symptoms – like nausea, photophobia, and phonophobia – than those who used the same device.

Summary of sTMS Device Facts based on FDA's approval

  • Portable, handheld and user-friendly
  • Available by prescription only
  • Approved only for individuals 18 years of age or older
  • Approved only for those who suffer from migraines with aura
  • Usage of the device should not exceed once in 24 hours
  • Device is contraindicated in individuals who have metals in the head, neck or upper body or if they have "an active implanted medical device such as a pacemaker or deep brain stimulator.'
  • FDA also warns that the device should not be used in individuals with a personal or family history of seizures.

Is This Device Available?

There is a post-market open-label study being done – until this is completed, the device will not be available in the United States.

Final Take Home Message

While this device is not for everyone and certainly not a guarantee, it may be worth a try when available and affordable. The nice thing about it is that it's noninvasive and not something you have to ingest. Regardless, more studies need to be done to better understand the mechanism behind the device, and whether it can be improved further. Speak with your doctor and get their opinion. As always, remain proactive in your headache and overall health.


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a migraine model. Nat Med 2002; 8: 136–42.

Dalkara T, Nozari A, Moskowitz MA. Migraine aura pathophysiology: the role of blood vessels and microembolization. Lancet Neurol. 2010 Mar;9(3):309-17

Holland PR, Schembri CT, Fredrick JP, Goadsby PJ. Transcranial magnetic stimulation for the treatment of migraine aura. Neurology
2009; 72 (suppl 3): A250 Accessed Jan 20, 2014.

Lipton RB, Dodick DW, Silberstein SD, Saper JR, Aurora SK, Pearlman SH et al. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomized, double-blind, parallel-group, sham-controlled trial. The Lancet Neurology. 2010 Apr;9(4):373-80.

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