The Spring single pulse transcranial magnetic stimulation (sTMS) device is approved by the FDA for the acute treatment of Migraine with aura. In Europe, it’s also approved for Migraine preventive treatment. From December 2014 to March 2016, a study was conducted in the United States to evaluate the effectiveness and safety of sTMS for the preventive treatment of Migraine with or without aura.
- The ESPOUSE Study was a multicenter, prospective, single-arm, open label, observational study to evaluate sTMS for the preventive treatment of Migraine with or without aura.
- From December 2014 to March 2016, 263 patients with Migraine completed a one-month baseline Migraine diary.
- The one-month diary period was followed by three months of treatment with sTMS.
- The treatment protocol included:
- preventive treatment of four pulses twice a day
- acute treatment of three pulses at 15-minute intervals up to three times during a Migraine attack
- The average number of Migraine days at the beginning of the three-month treatment period was 9.1 days (baseline).
- There was an average reduction of 2.8 Migraine days (30.7 percent) from baseline.
- In the absence of a placebo control group, the primary effectiveness endpoint was compared to the performance goal, which is a statistically-derived, estimated placebo effect size, based on historical controls, of 0.6-day reduction of Migraine days from baseline. Thus, we would compare a reduction of 2.8 Migraine days in the study group with a placebo rate of 0.6 days.
- The top three adverse events were:
- lightheadedness (4.5%)
- tingling (3.9%)
- tinnitus (3.9%)
- There were no serious adverse events.
- Nine patients withdrew from the study because of adverse events.
“This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention.”
Summary and implications for patients:
The sTMS device works for acute treatment of Migraine by disrupting the cortical spreading depression that drives Migraine attacks. Preventively, it works by keeping cortical spreading depression from starting. As with other Migraine treatments, sTMS doesn’t work for everyone, but unlike medications, it shouldn’t stop working for those for whom it’s effective.
Migraine patients who tend to experience side effects from Migraine preventive medications may find sTMS a good alternative.
Starling A, Tepper S, Marmura M, et. al. A Multicenter Prospective, Single Arm, Open Label, Post-Market, Observational Study to Evaluate the Use of sTMS in Reduction of Migraine Headache (ESPOUSE Study). Research paper presentation. American Headache Society Scientific Meeting. June, 2017.
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