Key takeaways:
- The Nerivio system supplied constant security, efficacy and tolerability with out vital dose enhance.
- Subsequent analysis will deal with preventive therapy with the system over 3 years.
MINNEAPOLIS — Remedy of migraine with distant electrical neuromodulation was secure and efficacious, and it didn’t require a major dose enhance with constant use over a interval of three years, in line with a poster.
“Conventional long-term remedies could have restricted adherence as a result of antagonistic occasions, drug-drug interactions, and lowering efficacy,” Alit Stark-Inbar, PhD, company vp of medical data at Theranica, instructed Healio concerning the analysis offered on the American Headache Society Annual Scientific Assembly.
Information have been derived from Nahas SJ, et al. Distant electrical neuromodulation exhibits constant efficacy with out tachyphylaxis over three years of therapy. Offered at: American Headache Society Annual Scientific Assembly; June 18-22, 2025; Minneapolis.
The REN wearable, a non-pharmacologic, wearable system for each acute and preventive migraine therapy of migraine, has been cleared by the FDA to be used in sufferers aged 8 years or older. The therapy has beforehand demonstrated security, efficacy and tolerability in addition to constant affected person use over a 1-year interval.
Stark-Inbar and colleagues sought to look at 3-year security, efficacy and tolerability and continued utilization of the Nerivio (Theranica) REN therapy in a real-world setting with out tachyphylaxis, the necessity for growing dosage.
Their potential cohort examine included 244 members (common age, 43.8 years; 85.7% girls) with migraine who have been prescribed the REN wearable and used it for 36 consecutive months. A smartphone app, which controls and screens the system, captured knowledge together with patient-reported person data.
The examine’s main endpoint was the dearth of a rise in annual common depth over the 3-year interval for the therapy, measured on a scale of 0 to 100.
Secondary endpoints included metrics of constant efficacy measured by ache reduction, ache freedom, mild and sound sensitivity, nausea freedom and general higher performance at 2 hours post-treatment for at the very least 50% of recorded utilization per yr for 3 years.
Extra security and tolerability endpoints examined frequency and stage of device-related antagonistic occasions reported through the app of help workers.
“On condition that migraine is a persistent illness, there’s a necessity for a secure, persistent therapy that can be utilized successfully for lengthy durations with out the necessity to regularly enhance dose ranges,” Stark-Inbar mentioned.
For 64,717 assaults handled by REN, the annual imply therapy intensities have been 35 for the primary yr, 36.8 within the second and 38.2 within the third. Common utilization per 30 days was 8 remedies within the first yr, 8.5 within the second and eight.8 within the third.Relating to efficacy, the typical proportion of responders was largely constant for all metrics throughout 3 years: ache reduction (74%, 77%, 72%); ache freedom (29%, 28%, 27%); practical incapacity enchancment (71%, 65%, 69%); photophobia (29%, 31%, 37%) and phonophobia freedom (49%, 38%, 49%) and freedom from nausea (62%, 67%, 57%).
Stark-Inbar moreover reported solely two of 224 members logged non-serious device-related antagonistic occasions (redness/rash on the pores and skin of the arm) however each elected to proceed therapy thereafter.
“This examine has direct medical implications, that well being care suppliers and sufferers can depend on the REN wearable therapy over lengthy phrases (years) of efficient, tolerable and secure drug-free therapy, with out the necessity to enhance therapy dosage,” Stark-Inbar instructed Healio. “Subsequent steps are to gather knowledge on the efficacy of preventive therapy over 3 years, which isn’t obtainable but.”
For extra data:
Alit Stark-Inbar, PhD, could be reached at data@theranica.com.
