Remote electrical neuromodulation for acute treatment of migraine in adolescents

Hershey, Andrew D.; Lin, Tamar; Gruper, Yaron; Harris, Dagan; Ironi, Alon; Berk, Thomas; Szperka, Christina L.; Berenson, Frank

doi:10.1111/head.14042

Cited by 41 publications

(53 citation statements)

References 27 publications

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“…Twelve participants (13.2%) reported mild short-term side effects, most of which were expected and have been observed in previous studies [17,23]. These results provide further support for the favorable tolerability and safety profile of REN found in clinical trials in episodic and chronic migraine in adults [16][17][18][19][20][21]23], and adolescents [24].…”

Section: Discussionsupporting

confidence: 84%

“…1). Efficacy studies have demonstrated that REN is safe and clinically beneficial for the acute treatment of migraine in adults with episodic migraine [16][17][18][19][20][21][22], adults with chronic migraine [23], and adolescents with migraine [24]. A comparison of the efficacy of REN to that of acute migraine medications indicated that REN has non-inferior efficacy compared to the tested acute migraine therapies [20].…”

Section: Introductionmentioning

confidence: 99%

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Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability

Nierenburg

Rabany²,

Lin³

et al. 2021

Pain Ther

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Introduction: Migraine is one of the most prevalent neurological disorders worldwide, and estimations are that 60% of women who suffer from migraines experience attacks that are associated with menstruation. Menstrual migraines are typically more debilitating and less responsive to pharmacological treatment. Remote electrical neuromodulation (REN) is a non-pharmacological abortive treatment of migraine headache. The current study evaluated the self-reported effectiveness and tolerability of REN for the acute treatment of menstrual migraine, via a retrospective structured survey that was sent to adult female REN users. Methods: Women aged 18-55 years who experience menstrually related or pure menstrual migraine and have completed at least four REN treatments, participated in this retrospective, observational survey study. Participants completed a short online survey assessing effectiveness, satisfaction, and safety outcomes.Results: Ninety-one participants qualified for the analysis, out of which 74.7% (68/91) reported that the treatment was at least moderately effective (moderately effective 37.4%, very effective 26.4%, extremely effective 11.0%). Additionally, 45.1% (41/91) reported satisfaction from REN (slightly satisfied 33%, extremely satisfied 12.1%), while 34.1% were neutral and 20.9% (19/91) were not satisfied. Lastly, 100% of the participants reported that the treatment is at least moderately tolerable (moderately tolerable 8.8%, very tolerable 20.9%, extremely tolerable 70.3%), and 13.2% (12/91) of respondents reported mild short-term side effects. Conclusions: Nearly 75% reported that the treatment was at least moderately effective, 45% reported satisfaction, and 100% of the participants reported that the treatment is at least moderately tolerable. Thirteen percent reported mild short-term side effects. REN was thus reported as effective for menstrual migraine by most participants and was very well tolerated. Therefore, REN may provide a safe, non-Supplementary Information The online version contains supplementary material available at

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Section: Discussionsupporting

confidence: 84%

Section: Introductionmentioning

confidence: 99%

Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability

Nierenburg

Rabany²,

Lin³

et al. 2021

Pain Ther

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“…The efficacy in adults has induced an open trial in children which was recently finished and suggested an efficacy also in children and adolescents [ 58 ].…”

Section: Neurostimulation Methodsmentioning

confidence: 99%

Non-Invasive Neurostimulation Methods for Acute and Preventive Migraine Treatment—A Narrative Review

Evers

2021

JCM

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Neurostimulation methods have now been studied for more than 20 years in migraine treatment. They can be divided into invasive and non-invasive methods. In this narrative review, the non-invasive methods are presented. The most commonly studied and used methods are vagal nerve stimulation, electric peripheral nerve stimulation, transcranial magnetic stimulation, and transcranial direct current stimulation. Other stimulation techniques, including mechanical stimulation, play only a minor role. Nearly all methods have been studied for acute attack treatment and for the prophylactic treatment of migraine. The evidence of efficacy is poor for most procedures, since no stimulation device is based on consistently positive, blinded, controlled trials with a sufficient number of patients. In addition, most studies on these devices enrolled patients who did not respond sufficiently to oral drug treatment, and so the role of neurostimulation in an average population of migraine patients is unknown. In the future, it is very important to conduct large, properly blinded and controlled trials performed by independent researchers. Otherwise, neurostimulation methods will only play a very minor role in the treatment of migraine.

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“…The REN device achieves therapeutic effects by delivering transcutaneous electrical stimulation to the upper arm, which induces conditioned pain modulation and activates a descending endogenous analgesia 73 . It was FDA‐cleared for the acute treatment of migraine in adults based on positive results in a randomized controlled clinical trial 45 ; it was cleared for the acute treatment of migraine and chronic migraine in patients aged 12 years and older based on data from an open‐label, single‐arm, multicenter study 74 . As with many nondrug therapeutic options, REN has shown good tolerability and safety in clinical trials; paresthesia in the area of the device was the most common side effect 45,46 …”

Section: Acute Treatmentmentioning

confidence: 99%

The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice

2021

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Objective To incorporate recent research findings, expert consensus, and patient perspectives into updated guidance on the use of new acute and preventive treatments for migraine in adults. Background The American Headache Society previously published a Consensus Statement on the use of newly introduced treatments for adults with migraine. This update, which is based on the expanded evidence base and emerging expert consensus concerning postapproval usage, provides practical recommendations in the absence of a formal guideline. Methods This update involved four steps: (1) review of data about the efficacy, safety, and clinical use of migraine treatments introduced since the previous Statement was published; (2) incorporation of these data into a proposed update; (3) review and commentary by the Board of Directors of the American Headache Society and patients and advocates associated with the American Migraine Foundation; (4) consideration of these collective insights and integration into an updated Consensus Statement. Results Since the last Consensus Statement, no evidence has emerged to alter the established principles of either acute or preventive treatment. Newly introduced acute treatments include two small‐molecule calcitonin gene‐related peptide (CGRP) receptor antagonists (ubrogepant, rimegepant); a serotonin (5‐HT1F) agonist (lasmiditan); a nonsteroidal anti‐inflammatory drug (celecoxib oral solution); and a neuromodulatory device (remote electrical neuromodulation). New preventive treatments include an intravenous anti‐CGRP ligand monoclonal antibody (eptinezumab). Several modalities, including neuromodulation (electrical trigeminal nerve stimulation, noninvasive vagus nerve stimulation, single‐pulse transcranial magnetic stimulation) and biobehavioral therapy (cognitive behavioral therapy, biofeedback, relaxation therapies, mindfulness‐based therapies, acceptance and commitment therapy) may be appropriate for either acute and/or preventive treatment; a neuromodulation device may be appropriate for acute migraine treatment only (remote electrical neuromodulation). Conclusions The integration of new treatments into clinical practice should be informed by the potential for benefit relative to established therapies, as well as by the characteristics and preferences of individual patients.

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Remote electrical neuromodulation for acute treatment of migraine in adolescents

Cited by 41 publications

References 27 publications

Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability

Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability

Non-Invasive Neurostimulation Methods for Acute and Preventive Migraine Treatment—A Narrative Review

The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice

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