While there is no cure for migraine, a Mayo Clinic study shows single-pulse trans-cranial magnetic stimulation is a safe, easy to use and non-invasive way to prevent migraine attacks.
Researchers at Mayo Clinic and other major academic headache centres across the US recently conducted the study that examined the effectiveness of using a single-pulse trans-cranial magnetic stimulation device to prevent migraine attacks. The eNeura SpringTMS Post-Market Observational US Study of Migraine study, also known as ESPOUSE, instructed participants to self-administer four pulses with the device in the morning and four pulses at night over three months to prevent and treat migraine attacks as needed. Spring TMS stands for Spring transcranial magnetic stimulation or sTMS.
"The migraine brain is hyper-excitable, and basic science studies have demonstrated modulation of neuronal excitability with this treatment modality," says Dr Amaal Starling, a Mayo Clinic neurologist, who is first author of the study. "Our study demonstrated that the four pulses emitted from this device twice daily reduce the frequency of headache days by about three days per month, and 46% of patients had at least 50% or less migraine attacks per month on the treatment protocol. This data is clinically significant. Based on the current study and prior studies in acute migraine attack treatment, sTMS not only helps to stop a migraine attack, but it also helps prevent them."
"For certain patients, treatment options for migraines, such as oral medications, are not effective, well-tolerated or preferred," Starling adds. "The sTMS may be a great option for these patients and allow doctors to better meet their unique needs."
The US Food and Drug Administration already had approved the sTMS device for the acute treatment of migraine with aura. The FDA now has approved it to prevent migraine, as well.
Objective: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine.
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.
Methods: The eNeura SpringTMS Post-Market Observational US Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 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 headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity.
Results: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher (p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events.
Conclusions: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention.
Amaal J Starling, Stewart J Tepper, Michael J Marmura, Ejaz A Shamim, Matthew S Robbins, Nada Hindiyeh, Andrew C Charles, Peter J Goadsby, Richard B Lipton, Stephen D Silberstein, Amy A Gelfand, Richard P Chiacchierini, David W Dodick
[link url="https://www.sciencedaily.com/releases/2018/03/180329095429.htm"]Mayo Clinic material[/link]
[link url="http://journals.sagepub.com/doi/10.1177/0333102418762525"]Cephalagia abstract[/link]