Remote Electrical Neuromodulation Device Effective for Migraine Prevention in Pivotal Trial - Patient Care Online

In adults with some episodic and chronic migraine headache, the distant physics neuromodulation (REN) instrumentality Nerivio (Theranica) demonstrated superiority implicit a placebo instrumentality successful reducing monthly migraine days erstwhile utilized for preventive treatment.

According to Theranica, the pivotal treble blind, randomized placebo-controlled objective proceedings met its superior endpoint, showing that successful migraine patients with astatine slightest a 6-month past of headaches, attraction with Nerivio resulted successful a simplification of 4.0 migraine days per period from baseline, compared with a simplification of 1.3 days successful the placebo radical (net therapeutic gain, 2.7 days; P<.001).

When investigators evaluated the interaction of Nerivio connected monthly migraine days separately for patients with chronic and episodic migraine, the erstwhile reported a simplification of 4.7 days, compared with 1.6 days for placebo (P =.001) and the second a simplification of 3.2 days, compared with 1.0 days for placebo (P = .003).

"These information show Nerivio's imaginable to supply a caller nonpharmacological preventive attraction enactment for radical with migraine,” said superior researcher Brian Grosberg, MD, director, Hartford Healthcare Headache Program successful Connecticut, said successful a statement. "The precocious efficacy of Nerivio compared to placebo, with favorable information and tolerability, suggests that REN could beryllium a beneficial nonpharmacological therapy enactment for some preventive and acute attraction of migraine, taxable to FDA approval."

The study’s 248 participants were aged 18 to 75 years, had a past of 6 to 24 headache days per 28-day play for each of the 3 months preceding the study. They were permitted to proceed uring 1 medicine with imaginable migraine-prophylactic effects. Excluded were immoderate patients with an progressive implanted electrical and/or neurostimulator device, uncontrolled epilepsy, a past of opioid oregon barbiturate use, oregon who mightiness person been large oregon been breastfeeding.

A screening sojourn was followed by a 4-week baseline phase, an 8-week double-blind preventive attraction phase, and a 4-week open-label phase.

According to the study, 40% of the 248 survey participants continued usage of preventive medications, chiefly prescribed oral medications, calcitonin gene-related peptide monoclonal antibody injections, and onabotulinumtoxinA injections. Among patients successful this subgroup the findings were akin to the wide cohort, with Nerivio attraction yielding a simplification of 3.5 monthly migraine days compared with 1.5 days for the placebo instrumentality (P = .03).

Analysis of respective further endpoints besides recovered attraction with Nerivio superior to that with placebo, including:

• Mean simplification of monthly all headache days from baseline: 4.5 days vs placebo 1.8 days p (P<.001)
• Reduction successful monthly moderate/severe headache days: 3.8 days vs 2.2 days; P =.005
• Mean reduction of acute-medication days: 3.5 days vs 1.4 days; P = .001
• Percentage of patients experiencing a simplification successful headache and moderate/severe headache days

Evidence continues to accumulate some from randomized trials and real-world studies for attraction of chronic symptom diseases, similar migraine, with nonpharmacologic therapies oregon on with medications, observed Alon Ironi, Theranica main enforcement officer.

"It is well-known that individuals with migraine person varied responses to therapies, and sometimes respond champion to a operation of antithetic modalities.” He adds that findings from the existent survey augment enactment for processing migraine therapies beyond pharmaceuticals.

The institution plans to taxable details of the survey to peer-reviewed publications and to contiguous the information astatine aboriginal technological conferences.

Reference: Grosberg B, Rabany L, Vizel M, et al. Effectiveness examination of distant electrical neuromodulation and standard-care medications for acute attraction of chronic migraine: a post-hoc analysis. Pain Manag. 2022;12:837-844. doi:10.2217/pmt-2022-0053.