Incorporating remote electrical neuromodulation into the standard of care may have a positive impact on migraine management by reducing the reliance on acute medications.
Morris Levin, MD
Results from a prospective, open-label extension study suggest that the use of remote electrical neuromodulation (REN) may reduce the overall reliance of acute migraine medications and thus may reduce the risk for medication overuse headache (MOH) if incorporated into standard of care.1,2
At 2 hours post-treatment, the rate of pain relief in ≥50% of the treatments was observed in 58.1% of patients (n = 68) in the run-in phase and 57.3% (n = 67) of patients in the open-label extension period (P = .999). Rates of pain freedom in ≥50% of the treatments at 2 hours post-treatment were 23.1% in the run-in phase compared with 30.8% in the open-label extension (P = .175). Meanwhile, the sham (n = 60) and double-blind treatment phase (n = 57) groups did not influence pain relief or pain-free outcomes (P = .735 for pain relief; P = .099 for pain-free).
During the open-label extension, 89.7% (105 of 117) of the participants treated their attacks only with REN and avoided medications compared to 15.4% (n = 18) in the run-in phase (P <.0001). Additionally, 73.5% (86 of 117) of the participants achieved >50% reduction in the number of attacks treated with medication and 42.7% (50 of 117) achieved 100% reduction in the number of attacks treated with medication when REN was available.
"This study signals a potentially significant shift in how we approach the acute treatment of migraine," lead author Michael Marmura, MD, headache specialist, Thomas Jefferson University Hospital, said in a statement. "Adding REN as an alternative to traditional migraine treatments opens the door to new long-term treatment strategies. What is most promising is the fact that so many patients in the study chose REN without being specifically prompted, and experienced treatment outcomes similar or slightly better than their usual care."
The parent study for this open-label extension was a randomized, double-blind, sham-controlled study (NCT03361423) conducted at 12 sites with 296 patients aged 18—75 years old who met the International Classification of Headache Disorders (ICHD; 3-beta) criteria for episodic migraine. The study was split into a run-in phase, which treated migraine attacks with usual care over a 2- to 4-week stretch, and an 8-week double-blind treatment phase.
Of the 296 participants, 160 continued to the open-label extension phase in which they incorporated a REN device into their usual care. Patients included in the study used Theranica Bioelectronics' Nerivio wearable device as the primary REN device. At baseline, researchers recorded pain scores of none, mild, moderate, or severe on pain relief and pain freedom at 2 hours post-treatment in ≥50% of the treated attacks, using the app. Medication use was also recorded in the app at 2 and 48 hours after treatment.
A total of 139 participants (86.9%) used the REN device at least once during the open-label extension. Of the 117 participants who treated at least 1 non-recurrent migraine headache with REN for whom pain intensity at 2 hours post-treatment was reported, 57 were in the active group during the double-blind treatment phase and 60 were in the sham group.
During the run-in phase (during which participants were not yet introduced to the REN device), migraine attacks were mostly moderate (52%; 210 of 404) or mild (35.4%; 143 of 404) in intensity when treated with usual care (which included pharmacological treatments or no pharmacological treatment). Severe attacks accounted for 51 (12.6%) of the 404 total non-recurrent migraine headaches treated with care.
Pain severity of the treated migraine attacks in the open-label extension was similar to that of the run-in phase, with pain severity either mostly mild (44.4%; 167 of 376) or moderate (42.3%; 159 of 376).
READ MORE: The Evolving Landscape of Migraine Treatment
Overall, 11 (7.9%) of the 139 participants who used the device at least once during the open-label extension phase reported at least 1 adverse event (AE) and 4 (2.9%) reported device-related AEs. Device-related AEs such as pain in arm/hand, shoulders and neck, and muscle spasm were all mild and resolved within 24 hours. There were no serious device-related AEs reported in the study.
"Traditionally we've had only a limited number of useful acute migraine treatments, many of which have side effects. REN is a welcome option, due to its apparent safety and almost nonexistent adverse effects. In addition, the risk of medication overuse, often a limiting factor with acute medications, should not be an issue when using a drug free therapy such as REN," Morris Levin, MD, chief, Headache Medicine division, and director, Headache Center, UCSF Medical Center, and chairman, independent Data and Safety Monitoring Committee of the study, said in a statement.
1. Frontiers in neurology publishes study evaluating remote electrical neuromodulation (REN) as viable alternative to drugs for acute migraine [news release]. Netanya, Israel: Theranica Bioelectronics; Published April 7, 2020. Accessed April 13, 2020. prnewswire.com/news-releases/frontiers-in-neurology-publishes-study-evaluating-remote-electrical-neuromodulation-ren-as-viable-alternative-to-drugs-for-acute-migraine-301036767.html
2. Marmura MJ, Lin T, Harris D, Ironi A, Rosen N. Incorporating remote electrical neuromodulation (REN) into usual care reduces acute migraine medication use: an open-label extension study. Front Neurol. Published online April 7, 2020. doi: 10.3389/fneur.2020.00226.