Migraine Treatment Device Receives FDA Clearance
First medical device marketed in U.S. for pain caused by migraine with aura
The FDA has issued a 510(k) clearance for the SpringTMS migraine treatment device (eNeura, Inc.). SpringTMS is the first medical device available to patients in the U.S. for the acute treatment of pain associated with migraine headache with aura.
SpringTMS is a prescription-only device that uses single-pulse transcranial magnetic stimulation (sTMS) to induce mild electrical currents that can depolarize neurons in the brain. This process is thought to interrupt the abnormal neuronal hyperactivity associated with migraine. The noninvasive device is designed for patient use. To treat, the device is placed at the back of the head, where it generates a focused magnetic pulse with the aim of eliminating the pain of a migraine headache.
The SpringTMS device provides the same therapy as eNeura’s first-generation sTMS device, Cerena, but offers improved portability. The Cerena device received FDA clearance in December 2013.The FDA reviewed a double-blind, placebo-controlled, randomized clinical trial of 201 patients. The study showed that nearly 38% of subjects who used the Cerena device when they had a migraine headache were pain-free 2 hours after using the device compared with approximately 17% of patients in the control group. After 24 hours, approximately 34% of the Cerena users were pain-free compared with 10% of the control group. The treatment did not produce any device-related serious adverse events.
Clinical efficacy data for the SpringTMS device were published online in the March 2, 2010 issue of The Lancet Neurology. Investigators conducted a randomized, double-blind, parallel-group, two-phase, sham-controlled study in the U.S. A total of 267 adults aged 18 to 68 years were enrolled into phase 1. All of the subjects had to meet international criteria for migraine with aura, with visual aura preceding at least 30% of migraines followed by moderate or severe headache in more than 90% of those attacks. Sixty-six subjects dropped out during phase 1.
In phase 2, 201 subjects were randomly assigned to receive either sTMS with the SpringTMS device (n = 102) or sham stimulation (n = 99). The subjects were instructed to treat up to three attacks over 3 months while experiencing aura. The trial’s primary outcome was a pain-free response 2 hours after the first attack, and co-primary outcomes were non-inferiority at 2 hours for nausea, photophobia, and phonophobia.
Thirty-seven patients did not treat a migraine attack and were excluded from outcome analyses. A total of 164 patients treated at least one attack with sTMS (n = 82) or sham stimulation (n = 82).
Pain-free response rates after 2 hours were significantly higher in the sTMS group (39% [32/82]) than in the group receiving sham stimulation (22% [18/82]), for a therapeutic gain of 17% (P = 0.0179). Sustained pain-free response rates significantly favored sTMS at 24 hours and 48 hours post-treatment. Treatment with sTMS was noninferior to sham stimulation for nausea, photophobia, and phonophobia. No device-related serious adverse events were recorded, and the incidence and severity of adverse events were similar between the two treatment groups.
The SpringTMS device will be launched at a select number of U.S. specialist headache centers.