Recently neuromodulation device gammaCore has received clearance from the US FDA for acute Migraine treatment in adults. The vagus nerve stimulation device was first approved by the FDA in April 2017 for the acute treatment of episodic cluster headaches and in January 2018 for Migraine.
gammaCore® (nVNS) is a non-invasive, hand-held medical device that treats the acute pain of a cluster headache attack or a Migraine attack by stimulating the vagus nerve. The device is held to the neck and mild electrical currents pass through the skin to stimulate the fibers of the vagus nerve, a large nerve system that connects the gut to the brain — a pathway that’s getting increased interest in the medical community, including those studying migraine. gammaCore passed the test in clinical studies as a new Migraine treatment, showing a significant reduction in acute Migraine or cluster headache pain after use of the device.
gammaCore is the third neuromodulation device approved by the FDA for acute Migraine treatment. Cefaly ACUTE was approved for acute use in September 2017. Meanwhile, eNeura’s TMS unit was approved for acute use in December 2013 While each device operates differently, they all offer patients the option of aborting a migraine attack without drugs, and minimal side effects.
The FDA cleared gammaCore for acute Migraine treatment based primarily on the results of a randomized, double-blind, sham-controlled trial called PRESTO (PRospectivE Study of nVNS for the Acute Treatment Of Migraine). The trial involved 243 patients with episodic Migraine. 120 participants received the device while 123 patients received a sham treatment as a control.
Results from PRESTO found that acute treatment with gammaCore was superior to sham for pain freedom at 30, 60, and 120 minutes after use. In the PRESTO study, as with previous studies, gammaCore was well-tolerated with a low incidence of adverse effects. The full results:
• 12.7% of patients who used gammaCore were pain-free after 30 minutes (compared to 4.2% control)
• 21% were pain-free after 60 minutes (compared to 10% in the control)
• 30% were pain-free after 120 minutes (compared to 19.7% control)*
• 41% had mild or no pain after 120 minutes (compared to 27.6% control)
*[Not statistically significant. The test was repeated to determine why the findings were not consistent at 120 minutes with the 30- and 60-minute findings. This second test confirmed that gammaCore was superior to the sham treatment after 120 minutes of use.]
Although gammaCore beat the sham treatment in the trial, only 41% of the 120 patients who received the device got complete relief or mostly complete relief after two hours. Like with most Migraine treatments, gammaCore cannot be expected to work for every person or with every attack. This new Migraine treatment does, however, provide an exciting option and new hope for those unsatisfied with their current acute treatment.
gammaCore is also available outside of the U.S., including in Canada and the European Economic Area. In the U.S., gammaCore is commercially available for the acute treatment of pain associated with episodic cluster headache in adults.
ElectroCore expects commercial availability of gammaCore for the acute treatment of pain associated with Migraine in adults in the second quarter of 2018
The Vagus nerve connects the brain to the gut, the uterus and more. Image: Nature
By A/PROF SANJAY RAGHAV
MBBS, MD, DM, FRACP
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