sTMS Proves Safe, Effective for Migraine With Medication Overuse

July 30, 2019

The use of single-pulse transcranial magnetic stimulation, while already FDA-approved for acute and preventive migraine treatment, has shown that it can be effective in reducing the need for acute headache medications in patients with migraine.

Peter J. Goadsby, MD, PhD, DSc

The use of single-pulse transcranial magnetic stimulation (sTMS) in the treatment of migraine with acute medication overuse is well-tolerated, safe, and effective, according to the findings of a study presented at the 2019 American Headache Society (AHS) Annual Meeting, July 11-14, 2019, in Philadelphia, Pennsylvania.1

The investigators, including Peter J. Goadsby, MD, PhD, DSc, professor of neurology, King’s College London and University of California San Francisco, evaluated the eNeura sTMS device in 39 patients over 6 months and ultimately found that 82% (n = 32) of them experienced a reduction in their use of acute medication doses per day.

Additionally, 74% (n = 29) of patients reported a reduction in migraine days. The response was deemed to be consistent over time as well as consistent across patient populations in tertiary headache care. “sTMS has previously shown efficacy in reducing migraine symptoms and acute medicines in the UK pilot program. Here we look at the treatment response of additional patients with medication overuse in open clinical practice,” Goadsby et al. wrote.

The daily pulse regimen was initiated at 1 pulse thrice daily, which could be escalated to a maximum of 8 pulses daily. The recommended dose escalation period was in weekly to bi-weekly increments as required. All patients in the assessment kept diary data to evaluate their medication use and migraine days.

“When the device is used preventatively, people apply a small device to the back of the head and push a button. It delivers a magnetic pulse that actually stimulates the brain, and that device also works both as an acute treatment and as a preventive treatment,” Richard B. Lipton, MD, explained in a NeurologyLive® Insights segment. The non-invasive device is believed to halt brain hyperactivity that is associated with migraine. Thus far, trials have shown that sTMS is as effective as migraine medications minus some risks and adverse effects.

A review article published earlier this year in Headache by Rashmi B. Halker Singh, MD; Jessica Ailani, MD; and Matthew S. Robbins, MD, noted that “sTMS is capable of inducing a current to the underlying cortex and changing the firing pattern and excitability of neurons. In migraine, it may disrupt cortical spreading depression, thus modulating the circuits in which pain is induced.”2

Previously, in the ESPOUSE study, which was conducted with 132 adult patients at 8 U.S. Headache Centers, a protocol of daily use resulted in 46% of patients reporting a ≥50% reduction in headache attacks, with a consistent safety profile, with the most common adverse events being lightheadedness, tingling, and tinnitus (all <4%). In the intent-to-treat analysis, patients used 4 pulses twice daily as prevention and an additional 3 pulses (up to 3 times per attack) for the acute treatment of migraine. At baseline, patients had 9.06 migraine days per month and used acute medications 5.24 days per month. At month 3, subjects had 2.75 fewer days of headache (P <.0001) and used 2.93 fewer days of acute headache medications (P <.0001).

In their review, Singh, Ailani, and Robbins concluded that “as stands, sTMS can be suggested to patients who request non-pharmacological options to treat migraine with the understanding of limited evidence.”

The device, manufactured by eNeura, is already approved for use by the FDA, and in February 2019, its indication was expanded to include the acute and preventive treatment of migraine in patients aged 12 years and older.3

For more coverage of AHS 2019, click here.

REFERENCES

1. Bhola R, Weatherby S, Ahmed F, et al. Use of Single Pulse Transcranial Magnetic Stimulation (sTMS) to Treat Migraine with Medication Overuse: Response Over Time. Presented at: 2019 American Headache Society Annual Meeting; July 11-14, 2019; Philadelphia, PA. P222LB

2. Singh RBH, Ailani J, Robbins MS. Neuromodulation for the Acute and Preventive Therapy

of Migraine and Cluster Headache. Headache. 2019;59:33-49. doi: 10.1111/head.13586.

3. eNeura, Inc. Receives FDA Clearance for Acute Treatment and Prevention of Migraine in Children 12 Years of Age and Older [press release]. Baltimore, MD: eNeura, Inc; Published February 27, 2019. eneura.com/press_releases/eneura-inc-receives-fda-clearance-for-acute-treatment-and-prevention-of-migraine-in-children-12-years-of-age-and-older. Accessed July 29, 2019.