Noninvasive nerve stimulation device eases migraine

External trigeminal nerve stimulation (e-TNS) helps relieve pain and reduce other symptoms associated with migraine, according to a recent study. E-TNS presents a safe, effective, noninvasive, and nonpharmacological intervention for migraine.

“This was the first randomized, sham-controlled trial examining a 2-hour e-TNS treatment for acute treatment of a migraine attack in an at-home scenario using a protocol design and outcomes for medications according to the FDA and International Headache Society (IHS) guidance,” the researchers said.

“E-TNS may be a clinically impactful alternative or complementary therapy in the stratified approach to acute management of migraine,” they added.

A total of 538 adults who experience two to eight migraine headaches per month participated in the present study and were given 2 hours of active or sham stimulation, both delivered via identical devices. Patients were taught how to self-administer e-TNS and were allowed to take the devices home. They were also asked to keep a migraine diary over the 2-month trial period.

The primary outcomes were pain freedom at 2 hours and freedom from the most bothersome migraine-associated symptoms (MBS) at 2 hours.

In the intention-to-treat analysis, 259 patients received the active intervention, of whom 25.5 percent were free of pain 2 hours after receiving the e-TNS device. In comparison, 18.3 percent of the 279 patients who received the sham device achieved pain freedom over the same time. The resulting therapeutic gain of 7.2 percent was statistically significant (p<0.05). [Sci Rep 2022;12:5110]

Similarly, the percentage of patients who reported resolution of their MBS after 2 hours was statistically higher in the active vs sham neurostimulation groups (56.4 percent vs 42.3 percent; therapeutic gain, 14.1 percent; p<0.01).

E-TNS was also significantly superior to sham as regards the secondary efficacy endpoints. After 2 hours, pain relief (69.5 percent vs 55.2 percent; p<0.01) and absence of any migraine-associated symptoms (42.5 percent vs 34.1 percent; p<0.05) were both higher in the active vs sham intervention groups. The same was true for sustained pain freedom (22.8 percent vs 15.8 percent; p<0.05) and relief (45.9 percent vs 34.4 percent; p<0.01) at 24 hours.

Logistic regression analysis adjusted for confounders confirmed that e-TNS use was a significant predictor of all efficacy outcomes.

Though effective, the use of the e-TNS device led to a significantly higher occurrence rate of adverse events than sham (8.5 percent vs 2.9 percent; p<0.01). All side effects were minor in severity and fully reversible without or with minimal intervention.

The present trial “provides the first phase III evidence demonstrating efficacy and safety of patient-administered, 2-hour e-TNS treatment for acute treatment of migraine with and without aura in the out-of-hospital setting,” the researchers said.

“While an in-hospital setting may have improved accurate migraine attack identification, the current study was conducted outside of a hospital setting so that efficacy of e-TNS could be assessed in an environment where the device is commonly used,” they added.

“Migraine intervention timing may be a critical variable in symptom response, and further study is needed to elucidate this finding,” the researchers said.