A study undertaken to evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine has led to an FDA extended indication.
Study Design. To investigate whether the FDA label could be extended to include migraine prevention, Starling and colleagues conducted the eNeura Spring TMS Post-Market Observational US Study of Migraine (ESPOUSE). The study used a multicenter, prospective, open-label, observational design and took place from December 2014 to March 2016. It included 217 adults with migraine (90% with episodic migraine, 10% with chronic migraine, 33% with aura, and 67% without aura).
sTMS Device. The researchers theorized that single pulse transcranial magnetic stimulation (sTMS), originally developed for the acute treatment of migraine, might also help prevent migraine. The study was published on January 1, 2018 in Cephalalgia.
Background. Based on results from this study, a previous randomized controlled trial, and post-marketing data in the UK, the FDA extended the indication for eNeura’s sTMS device, SpringTMS® (the only product available to patients in the US for both acute migraine treatment and migraine prevention).[2,3] “Prior open label patient experience suggested a preventive benefit [for the treatment of migraine with sTMS], and this current open label study provides additional evidence for the preventive benefit in patients with migraine when used daily. All studies support the safety and tolerability of this treatment method.”
sTMS. SpringTMS® is a portable device that weighs about 1.5 kg. By placing it against the occiput and pushing a button, patients can use the device to deliver a pulse of electrical current across the skull to modulate neurons. Each pulse lasts about one minute.
Methods. Participants used a diary to record baseline migraine symptoms for one month before starting treatment. They then started 3 months of sTMS. Preventive treatment consisted of 4 pulses 2 times daily, for a total treatment time of about 2 minutes. Acute treatment consisted of 3 pulses, repeated up to 3 times for each episode. The primary endpoint was mean reduction from baseline in headache days, compared with a statistically derived placebo value.
Key Results. Compared with placebo there were 2.75 fewer headache days with sTMS (P < .0001); 46% of the sTMS group and 20% of the placebo group had at least 50% improvement in symptoms (P < .0001); there was significantly less acute medication use, less headache impact, and less headache intensity with sTMS compared with placebo (P < .0001 for all). The most common adverse effects included lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%).
Limitations. The study was limited by the inability to create a true sham control device, which would have allowed for a randomized controlled design. Because the study comprised mostly white women, results may not be applicable to a more diverse population.
Take Home Points. Findings from ESPOUSE show that compared with placebo the use of an sTMS device results in almost 3 fewer migraine days per month. Significantly more patients in the active treatment group experienced at least 50% improvement in symptoms; they had less need for acute medication as well a improvement in headache impact and intensity. Based on these results and 2 earlier studies, the FDA expanded the indication for the portable sTMS device SpringTMS® to include migraine prevention.