The innovative remote electrical neuromodulation (REN) treatment, Nerivio, has demonstrated early effectiveness in preventing migraine attacks within just two weeks, according to recent research. This is a significant breakthrough for those who suffer from migraines and are seeking faster, more effective treatments.
The Power of REN Treatment
Dr. Rashmi B. Halker Singh, an associate professor of neurology at Mayo Clinic, emphasized the importance of speed alongside efficacy when it comes to treating migraines. She revealed that the U.S. Food and Drug Administration (FDA) recently cleared the Nerivio device for migraine prevention, following its earlier approval for on-demand migraine treatment in adolescents and adults.
The clearance was based on studies showing its effectiveness after three months of treatment. However, the latest analysis aimed to identify how soon the benefits could be observed.
Unveiling the Findings
The FDA’s endorsement of REN for acute or preventive treatment for migraines, whether accompanied by an aura or not, was founded on data from a rigorous randomized controlled trial. This trial was led by Dr. Stewart J. Tepper, a Professor of Neurology at the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire.
The results of this study were significant: patients who used the Nerivio device saw an average reduction of 4 migraine days per month from their initial baseline. In contrast, those using a placebo only experienced a reduction of 1.3 days. This resulted in a net therapeutic gain of 2.7 days for those using Nerivio.
Dr. Rashmi B. Halker Singh, an associate professor of neurology at Mayo Clinic, highlighted the importance of neuromodulation as a treatment option. She pointed out that it broadens the scope of available treatments, which is crucial given that some people may either resist taking medication or find it insufficient for their needs. “It’s just nice to have more options,” she said, emphasizing the benefits of this new approach.
Studying Temporal Patterns of Response to REN Treatment
To examine the timing of the response to remote electrical neuromodulation (REN) treatment, Dr. Halker Singh and her team conducted a study over two months where the treatment was administered every second day as a preventative measure against migraines.
The study involved randomly assigning patients to either receive a REN device (95 participants) or a placebo device (84 participants). Those who were assigned the placebo device received stimulation from a sham gadget.
Participants were instructed to use their respective devices bi-daily for eight weeks. They were also asked to log their migraine episodes daily using a smartphone application.
Every two weeks, the team calculated the average number of monthly migraine days for each group. Remarkably, within the first two weeks, a statistically significant difference was observed between the active treatment and placebo groups. Users of the REN device reported an average decrease of 1.2 migraine days, compared to a meager reduction of 0.31 days in the placebo group.
This gap continued to widen and remained consistent throughout the duration of the eight-week trial.
Dr. Halker Singh also noted that the response time varied based on the type of migraine. Individuals with episodic migraines typically responded to REN treatment within two weeks, while those with chronic migraines generally took up to six weeks to respond.
Promising News for Migraine Sufferers
Dr. Larry Charleston IV, director of Headache and Facial Pain and professor of neurology and ophthalmology at Michigan State University, stressed the importance of targeted treatments for migraine pathophysiology. He explained that unlike most transcutaneous electrical nerve stimulation devices, which modulate A-beta pain fibers, the REN device neuromodulates the A-delta fibers and C-fibers known to be involved in migraines.
Dr. Charleston believes this is certainly good news for those with migraines, as the new treatment options target their specific disease and may offer preventive benefits as early as two weeks. He also noted that neuromodulation might continue to provide more benefits over time for patients with migraines. He concluded that many providers, including himself, are eager to see newer, safe, and effective migraine-specific treatments become accessible to their patients.