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In an at-home setting, the use of 2-hours external trigeminal nerve stimulation is an efficacious and safe, non-pharmacological, non-invasive substitute to treat migraine attacks.
In a randomized, prospective, phase 3 trial (TEAM study), treatment with two hours external trigeminal nerve stimulation (e-TNS) therapy in acute migraine resulted in considerably improved rates of migraine pain freedom, and resolution of migraine-associated bothersome symptoms (MBS) when compared to the sham group.
Investigators aimed to determine safety and effectiveness of self-administered, 2-h (two consecutive 1-h) e-TNS therapies for migraine attacks, with and without aura, in an at-home scenario. In this study, 538 subjects fulfilling International Classification of Headache Disorders 3rd edition (ICHD-3) criteria for two-eight migraine headache days per month were enrolled.
Adult subjects were randomly segregated to two-hour active or sham stimulation. With the aid of a paper diary, recording of the migraine pain levels and MBS was done at baseline, 2 hours, and 24 hours. Freedom from MBS at 2 hours and pain freedom at 2 hours were the major outcomes of this multicenter, sham-controlled, double-blind study. Pain alleviation at two hours, resolution of any migraine-associated symptom at two hours, acute medication usage within 24 hours after treatment, sustained pain freedom, and sustained pain mitigation at 24 hours were the secondary outcomes ascertained.
Collection of adverse event data was done and compared between the study groups. In total, 538 people were randomly allocated to either verum (n = 259) or sham (n = 279) group and were incorporated in the intention-to-treat analysis. The percentage of people with pain freedom at 2 hours was 7.2% greater in verum in comparison with sham. The resolution of MBS was 14.1% more in verum group compared to sham group.
Regarding secondary endpoints, the verum group exhibited 14.3% more pain mitigation at 2 hours, 8.4% higher absence of all migraine-associated symptoms at 2 hours, 7.0% more sustained pain freedom, and 11.5% higher sustained pain relief at 24 hours when compared to the sham group, as shown in Table 1:
There were no severe side effects noted. Thus, the two hour e-TNS is beneficial for acute therapy of migraine attacks.
Scientific Reports
Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM)
Deena E. Kuruvilla et al.
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