sTMS for Migraine Prevention: ESPOUSE Study Results

The results of the eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) were recently published showing the efficacy of sTMS for Migraine prevention. sTMS stands for single-pulse transcranial magnetic stimulation. The SpringTMS device from eNeura was approved by the FDA for the acute treatment of Migraine with Aura on May 23, 2014. On September 7, 2017, it received FDA approval for the preventive treatment of Migraine, making it the only device with FDA approval for both acute and preventive treatment.

The Study:

Study Objective:

“To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine.”

Study Background:

“sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention.”

Study Methods:

• The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study.
• From December 2014 to March 2016, patients with migraine (n¼263) were consented to complete a one-month baseline Migraine diary followed by three months of treatment.
• The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment.
• Patients reported daily Meadache status, medication use, and device use with a monthly Migraine diary.
• The primary endpoint, mean reduction of Migraine days compared to baseline, was measured over the 28-day period during weeks nine to 12.
• The primary endpoint was compared to a statistically derived placebo estimate (performance goal).
• Secondary endpoints included:
  • 50% responder rate,
  • acute Meadache medication consumption,
  • HIT-6,
  • and mean reduction in total Migraine days of any intensity days from baseline.

Study Results:

• 132 patients were involved in the study: 90 percent with episodic Migraine, and 10 percent with chronic Migraine
• Participants used the SpringTMS unit for three months for both acute and preventive treatment. Daily preventive treatment was four pulses twice a day. Acute treatment was three consecutive pulses repeated up to three times for each Migraine attack.
• At baseline, there were an average of 9.06 Migraine days. At the end of the three-month period, patients averaged three fewer Migraine days per month, regardless of Migraine type.
• 46 percent of study participants had a greater than 50% reduction in the number of Migraine days, as well as a significant reduction in disability and the number of days they used acute medications.
• There was a reduction of 2.93 days of acute medication use.
• Measured by HIT-6, there was a reduction of 3.16 days in the total number of days with Migraine of any intensity.
• The most common adverse events were:
  • lightheadedness (3.7%),
  • tingling (3.2%), and
  • tinnitus (3.2%).

• There were no serious adverse events.

Study Conclusion:

• “This open label study met its primary endpoint and prespecified, multiplicity-protected secondary endpoints,suggesting that sTMS may be an effective preventive treatment for migraine with or without aura. Overall, 46% of the subjects had a greater than 50% reduction in the number of headache days, and there was a significant reduction in disability and in the days of acute medication use. In addition, the treatment was safe and well tolerated. There were no serious adverse events and only 4% (9/217) withdrew due to adverse events.”

Comments and Implications for Patients:

This study showed sTMS for Migraine prevention to be a viable option in addition to it’s use for treating acute Migraine. For acute use, sTMS offers an abortive treatment option for patients who cannot take triptans or ergotamines due to heart issues. It also avoids the issue of potential Medication Overuse Headache. Additionally, sTMS for Migraine prevention offers an option with a much lower potential side effects profile than other treatments. For patients for whom sTMS works both acutely and preventively, it affords the convenience and simplicity of using a single treatment option for both acute and preventive needs.

Sources

1. 1. Starling AJ, Tepper SJ, Marmura MJ, et al. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). [published online March 4, 2018]. Cephalalgia Vol 38, Issue 6, pp. 1038 – 1048.