Real-world Experience with Remote Electrical Neuromodulation in the Acute Treatment of Migraine

Tepper et al., Pain Medicine, 2020

Objective: Remote electrical neuromodulation (REN) is a nonpharmacological acute migraine treatment that stimulates upper-arm peripheral nerves. The aim of this investigation was to evaluate the effectiveness and safety of REN for acute treatment of migraine in a real-world setting.

Methods: Real-world data were collected from patients who were using REN (Nerivio®, Theranica Bio-Electronics Ltd., Israel) between October 1, 2019, and March 31, 2020. Patients recorded their symptoms at baseline, two hours, and 24 hours post-treatment. Patients were stratified based on the type of visit and provider; in-person visits with headache specialists (HS group) or virtual visits with nonheadache specialists (NHS group). Efficacy outcome focused on intra-individual consistency of response across multiple attacks.

Results: We found that 58.9% (662/1,123) of the patients in the HS group and 74.2% (23/31) of the patients in the NHS group experienced pain relief at two hours in at least 50% of their treated attacks and 20.0% (268/1,339) of the patients in the HS group and 35.6% (16/45) of the patients in the NHS group experienced pain freedom at two hours in at least 50% of their treated attacks. The effects of REN on associated symptoms and improvement in function were also consistent in both groups. The incidence of device-related adverse events was very low (0.5%).

Efficacy outcomes in the two migraine cohorts
HS Group, % (n/N) NHS Group, % (n/N) P Value
Consistency of pain-relief response at 2 h 58.9 (662/1,123) 74.2 (23/31) 0.09
Consistency of pain-free response at 2 h 20.0 (268/1,339) 35.6 (16/45) 0.01
Consistency of disappearance of at least 1 associated symptom at 2 h 55.5 (614/1,107) 65.8 (25/38) 0.21
Consistency of improvement in function at 2 h 52.9 (644/1,218) 66.7 (26/39) 0.09
Consistency of return to normal function at 2 h 25.8 (314/1,218) 51.3 (20/39) 0.0001
Consistency of sustained pain relief response at 24 h 46.6 (142/305) N/A N/A
Consistency of sustained pain-free response at 24 h 46.9 (69/147) N/A N/A

Table 1 - Efficacy outcomes in the two migraine cohorts

*HS = headache specialists

Conclusions: Real-world data confirm that REN results in meaningful clinical benefits with minimal side effects. REN may provide an effective drug-free treatment option for achieving consistent relief from migraine symptoms and may reduce the use of acute medications.