A recent open-label study, the eNeura S pringTMS P ost-Market O bservational U .S. S tudy of Migrain e (ESPOUSE), has indicated that single-pulse transcranial magnetic stimulation (sTMS) could be a viable option for migraine prevention. The study, involving 217 subjects, explored the efficacy and tolerability of sTMS for individuals experiencing migraine with or without aura.
The study's primary endpoint, the mean reduction of headache days compared to baseline, was measured over a 28-day period during weeks 9 to 12. Results showed a significant reduction of -2.75 days from a baseline of 9.06 days (p < 0.0001), compared to a performance goal of -0.63 days. This suggests a clinically meaningful benefit for patients using sTMS preventively.
Key Findings on Efficacy
Beyond the primary endpoint, the study also assessed several secondary endpoints. Notably, 46% of participants achieved a 50% or greater reduction in headache days (p < 0.0001). Furthermore, there was a reduction of -2.93 days in acute medication use and a significant improvement in the Headache Impact Test (HIT-6) score, with a reduction of -3.1 (p < 0.0001).
"These findings suggest that sTMS may offer a valuable non-pharmacological approach to migraine prevention," said Dr. Amaal J Starling, lead author of the study. "The observed reduction in headache days and acute medication use could significantly improve the quality of life for migraine sufferers."
Safety and Tolerability
The safety profile of sTMS was favorable, with no serious adverse events reported. The most common adverse events were mild and transient, including lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). This is an important consideration for patients who may be intolerant to traditional migraine medications.
Study Design and Methodology
The ESPOUSE study was a multicenter, prospective, open-label, observational study conducted across various headache subspecialty clinics in the United States. Participants aged 18 to 65 with a diagnosis of migraine (with or without aura) and experiencing 4 to 25 headache days per month were included. The treatment protocol involved preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment using a portable sTMS device.
Context and Comparison
Migraine is a prevalent neurological disorder affecting over 38 million people in the United States. Current treatments often have limitations in efficacy, tolerability, or adherence. sTMS offers a non-invasive, non-pharmacological alternative that may address some of these unmet needs.
Limitations and Future Directions
The study's open-label design and lack of a control group are limitations. However, the statistically significant results and favorable safety profile warrant further investigation in randomized, controlled trials. Future research should also explore the efficacy of sTMS in specific migraine subtypes and identify predictors of treatment response.
Implications for Clinical Practice
The results of the ESPOUSE study suggest that sTMS could be a valuable addition to the migraine treatment armamentarium. Its ease of use, favorable safety profile, and potential for both acute and preventive benefits make it an appealing option for patients seeking non-pharmacological alternatives.
