Med Device Monday: ThermoNeuroModulation Device to Treat Migraines

It’s Medical Device Monday! As excited as we are here at AcKnowledge RS about Mondays, it is known by many as #MigraineMonday on social media. Well, today we have some exciting news for sufferers: a stimulator by Scion NeuroStim LLC called the ThermoNeuroModulation (TNM) Device. Although it is currently for prescription use only, it is still a step forward for those who experience migraines.

 IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

IMAGE FROM http://www.accessdata.fda.gov/fda.gov/cdrh_docs/reviews/DEN170023.pdf

Over 39 million Americans suffer from migraines; 2-3 million of those 38 million suffer from chronic migraines. During a migraine, a person may experience a variety of symptoms including vertigo, pain, sensitivity to light, or nausea. Some people suffer from vestibular migraines that cause repeated bouts of dizziness and may or may not include headache. Vestibular migraines can also lead to issues with balance, extreme motion sensitivity, vomiting, and feeling disoriented.  

Migraine treatments for traditional migraines are relatively limited; you can take pain-relieving medications or preventive medications, depending on the severity and frequency of your migraines. Pain-relieving medications can range from ibuprofen to opioids. Preventive medications include cardiovascular drugs, antidepressants, Botox, and even anti-seizure drugs. Both approaches clearly involve the use of pharmaceuticals, and unfortunately may not alleviate pain or prevent migraines from happening again.

The TNM Device is a non-drug solution for migraines that was granted through the de novo process in April 2017. Per the device description in the FDA de novo Classification Request:

“The TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.”

The device is a non-invasive, home-use, DC-powered device that uses an over-the-ear headset with metallic earpieces that protrude into the external ear canals. While the user reclines and relaxes during treatment, the earpieces change temperature from 16-42°C. The controlled thermal fluctuations interact with the user’s vestibular system, causing changes that are used to treat their migraine headaches. The control unit with touchscreen display allows the patient to manage the treatment.

The TNM Device was studied in a multi-center, triple-blind, placebo-controlled, randomized study. Half of the patients were treated with the device while the other half received a placebo device. After three months of treatment, patients experienced a 21% decrease in total headache pain scores and the duration of migraine days decreased from 7 to 4.

The de novo pathway provided a mechanism for devices such as the TNM Device to undergo FDA review even though there are no other devices like it on the market. We hope that this device can help those who suffer from migraines. After all, don’t we all want a migraine-free Monday/week/life?

Are you interested in the de novo pathway? Check out our original blog post and update about if the de novo pathway is right for your device!

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