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Clinical Edge Journal Scan Commentary: Migraine May 2022


Cefaly is a generally used nonprescription machine that makes use of exterior trigeminal nerve stimulation (e-TNS) to both abort or forestall migraine assaults. The pivotal Cefaly research was printed about 10 years in the past, and Cefaly was the primary US Meals and Drug Administration–cleared neurostimulation machine for headache. The preliminary acute information have been gathered primarily within the hospital setting, and the investigators within the research by Kuruvilla and colleagues supposed to duplicate a extra real-world situation for the acute use of Cefaly.

This was a potential, multicenter, sham-controlled research. Sufferers have been enrolled in the event that they developed migraine previous to age 50 years and skilled two to eight assaults per 30 days of reasonable to extreme depth. Sufferers have been randomized to both Cefaly or a sham machine. The Cefaly machine itself has two setting: acute and preventive. For this research, the acute setting was used for two hours at a time throughout an acute assault (inside the first 4 hours). The supraorbital and supratrochlear branches of trigeminal nerves bilaterally are stimulated with a steady stimulation through a self-adhesive electrode. This has beforehand been proven to be secure and efficient with the commonest facet impact famous to be pores and skin irritation on the electrode website.

Sufferers collected information about their complications in an e-diary and continued to deal with for two months. The co-primary outcomes have been headache freedom and determination of most bothersome syndrome at 2 hours. Secondary outcomes have been ache aid at 2 hours, decision of any migraine-associated symptom at 2 hours after starting e-TNS remedy, sustained ache freedom (outlined as ache freedom at 2 hours and ache freedom at 24 hours with out the usage of antimigraine medicine throughout these 24 hours), and use of a rescue medicine between 2 and 24 hours after starting an e-TNS session.

A complete of 538 sufferers have been enrolled. The share of sufferers with each freedom from ache and determination of probably the most bothersome signs have been statistically totally different within the intervention and sham teams. The secondary outcomes have been additionally statistically improved within the machine group, except for use of rescue medicines between 2 and 24 hours. The commonest adversarial occasions have been brow discomfort and paresthesia.

This research does present the effectiveness of Cefaly, particularly when used for longer durations of time than had been beforehand beneficial. The outcomes have been all met except for rescue medicine use, and there’s no contraindication to utilizing any rescue medicine whereas utilizing the Cefaly machine. Cefaly may be a superb add-on for acute remedy, particularly in sufferers that will want to make use of a couple of intervention acutely for his or her migraine assaults.

Suppliers usually focus on when to begin medicines however don’t as usually focus on when to cease medicines. That is very true for preventive medicines for migraine. The very best-case situation is {that a} preventive medicine is so efficient that it’s not essential; however in different circumstances, preventive medicines should be stopped, as an example, throughout being pregnant planning. One concern particularly when beginning and stopping a monoclonal antibody (mAb) medicine is the event of neutralizing antibodies to negate the impact of restarting the medicine. This research was designed to find out whether or not restarting calcitonin gene-related peptide (CGRP)–mAb medicines was nonetheless efficient after having been beforehand stopped.

Raffaelli and colleagues managed a small (39 sufferers) open-label potential research. Sufferers both had a analysis of episodic or continual migraine and have been initially given CGRP-mAbs for a minimum of 8 months. They then stopped the remedy for a minimum of 3 months and have been restarted on the identical mAb that they’d initially used. They tracked their headache signs for 3 months after restarting remedy. If one other remedy had been began in between, these sufferers have been excluded.

The first consequence was change in imply month-to-month migraine days between the final 4 weeks of remedy discontinuation and weeks 9-12 after restarting remedy. Secondary endpoints have been the modifications in imply month-to-month headache days throughout the opposite statement factors and Headache Affect Check-6 (HIT-6) sum scores. Of the 39 sufferers enrolled, 16 got erenumab, 15 galcanezumab, and eight fremanezumab.

Imply migraine days and imply headache days have been proven to have a statistically vital lower after resumption of remedy. Restarting CGRP medicines was not related to different adversarial occasions related to these medicines. This offers us proof in favor of restarting the identical CGRP medicine when a affected person’s signs begin to worsen after they’ve discontinued due to enchancment or after being pregnant and breastfeeding.

The usage of implanted units for migraine remedy is taken into account considerably controversial. Surgical interventions and implantations for migraine haven’t been effectively studied; nevertheless small case sequence have been printed, and non-neurologists report anecdotally that these interventions may be useful for refractory headache issues. The research by Evans and colleagues reviewed through meta-analysis a lot of the prior information for nerve stimulation in migraine.

Research included on this meta-analysis have been English-language, peer-reviewed articles of potential research with sufferers over age 18 years for migraine identified in line with Worldwide Classification of Headache Problems (ICHD) standards. The units have been transcutaneous nerve stimulator units in a single area of the top ( occipital, supraorbital/supratrochlear areas) and enrolled a minimal of 10 sufferers within the remedy teams. A complete of 14 research have been recognized; 13 of the research did report vital adversarial occasions associated to remedy.

Relating to migraine frequency, solely 4 of the research have been thought-about comparable, investigating episodic migraine with 2-3 months of transcutaneous stimulation, and two have been comparable in investigating continual migraine. The episodic migraine research had a pooled discount by 2.8 days of migraine per 30 days; continual migraine was famous to be 2.97 days fewer per 30 days. Three comparable research for episodic migraine confirmed a pooled discount in severity by 2.23 factors after 3 months.

Occipital and different trigeminal department stimulation implants are invasive and related to threat, most prominently resulting in migration and worsening headache and neck ache. This meta-analysis did reveal essential pooled information, however it turns into much less spectacular when contemplating the printed information for normal oral or injection therapies. The truth that there may be long-term worsening and adversarial occasions with surgical implantation makes this alternative a better threat. Of word, there are actually neurostimulation units, comparable to Cefaly, that permit comparable transcutaneous stimulation with out the danger of surgical procedure.



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