Migraine: Remote Electrical Neuromodulation For Pain Relief in Adolescents

PainRelief.com Interview with:
Andrew D. Hershey, MD, PhD, FAAN, FAHS
Endowed Chair and Director of Neurology
Professor of Pediatrics and Neurology
Director, Headache Center
Cincinnati Children’s Hospital Medical Center
Cincinnati, OH 45229
University of Cincinnati, College of Medicine

PainRelief.com:  What is the background for this study?

Response:  Migraine is a common and debilitating disease, affecting 1 in 10 children and adolescents worldwide. Refractory migraine in adolescents may be associated with poorer academic performance, reduced school attendance, and a negative effect on social interactions. Current acute treatments for adolescents with migraine are mostly pharmacological. These treatments may cause side effects, and their frequent use may potentially lead to medication overuse headache. Additionally, their efficacy may be variable or inadequate. Thus, there is a great unmet need for new safe and effective acute treatments for adolescents with migraine headaches.

Remote Electrical Neuromodulation (REN) is a non-pharmacological, non-invasive neuromodulatory treatment that has been approved by the US FDA for acute treatment of the headache attacks of migraine in patients 12 years of age or older. The REN device (Nerivio®) is a small stimulator controlled by the user via a smartphone application and activates one of the body’s own pain suppression system by inducing weak electrical currents. These currents stimulate nerve fibers in the upper arm to activate an endogenous descending pain inhibition mechanism termed Conditioned Pain Modulation (CPM). Clinical trials of REN have shown efficacy and safety of the treatment in adolescents 12 and older, as well as in adults.

The current study is the first to compare REN and standard-care treatments (over the counter medications and triptans) in adolescents.

PainRelief.com: What are the main findings?

Response:   The main findings indicate that following the treatment, 71% of the participants experienced pain relief when using REN, whereas when using medications only 57% experienced pain relief. Pain freedom was experienced by 37% of the participants when using REN, while only 9% of the participants when using medications, a statistically significant difference. Consistency of pain relief and freedom was achieved in significantly more patients following REN treatments then following medication treatments. 

PainRelief.com: What should readers take away from your report?

Response:   Our results provide preliminary indication that REN may be as effective, if not more effective, than certain standard-care medications in adolescents with migraine. Combined with its low rate of side effects, REN may thus offer a safe and helpful additional alternative for current pharmacological treatments and should thus be considered by physicians and patients as treatment for teenagers with migraine.

PainRelief.com:  What recommendations do you have for future research as a result of this study?

Response:  Future research is needed to further establish these results in a larger, prospective study, in which each type of medication (i.e. triptans, over-the-counter medications) will be compared to REN separately and directly. However, while corroboration is needed in a larger prospective sample, significant differences were found even within the current sample, suggesting a true difference.

PainRelief.com: Is there anything else you would like to add?

Response: The field of neuromodulatory treatments for migraine is new and exciting. More and more evidence indicates that neuromodulation treatments for migraine are safe and effective. Recently, the American Headache Society also included neuromodulation treatments as part of the official recommendations for migraine treatment under various clinical circumstances. The current study adds to that growing body of evidence by demonstrating that neuromodulation, and REN specifically, can be not only as effective as some pharmacological treatments, but potentially even more effective in some cases.  

It should be disclosed that the study was funded and performed by Theranica Bio-Electronics LTD.

Citation:

Hershey AD, Irwin S, Rabany L, Gruper Y, Ironi A, Harris D, Sharon R, McVige J. Comparison of remote electrical neuromodulation (REN) and standard-care medications for acute treatment of migraine in adolescents: a post-hoc analysis. Pain Med. 2021 Jun 29:pnab197. doi: 10.1093/pm/pnab197. Epub ahead of print. PMID: 34185084.

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