Noninvasive Neuromodulation in Migraine.

PURPOSE OF REVIEW: The past two decades has seen an influx of noninvasive neuromodulation devices aimed at treatment of various primary headache disorders, including cluster headache and migraine. This narrative review is to summarize the current options in noninvasive neuromodulation in migraine. RECENT FINDINGS: A variety of noninvasive neuromodulation devices have been FDA cleared and marketed for use in migraine, including single-pulse transcranial magnetic stimulation (sTMS), noninvasive vagal nerve stimulators (nVNS), and external trigeminal nerve stimulators (eTNS). Newer devices include peripheral electrical stimulation devices (PES), caloric stimulation, and others. Each has varying levels of evidence supporting its use in migraine, tolerability profiles, and access issues. Noninvasive neuromodulation devices can be beneficial when used in patients with migraine, with minimal side effects. As more devices are developed, approved, and marketed in the future, rigorous research on efficacy and safety remain a top priority

OnabotulinumtoxinA in the treatment of patients with chronic migraine: clinical evidence and experience

Chronic migraine is a debilitating neurobiological disorder that affects approximately 1.4–2.2% of the population worldwide. Patients with chronic migraine have 15 or more headache days per month, with at least 8 days per month that meet the criteria for migraine. Injection of onabotulinumtoxinA, using a standardized injection protocol, was approved by the US Food and Drug Administration in 2010 for the treatment of chronic migraine. The approval was made based on results from two large, randomized, double-blind placebo-controlled trials: the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials. Since then, numerous studies have been performed investigating the short-term and long-term benefits, risks and complications of the use of onabotulinumtoxinA injections for the treatment of chronic migraine. The purpose of this narrative review is to describe the currently available clinical evidence for the use of onabotulinumtoxinA injections for treating patients with chronic migraine

Variability of the modified Balance Error Scoring System at baseline using objective and subjective balance measures

Aim: To investigate preseason modified Balance Error Scoring System (mBESS) performance in a collegiate football cohort; to compare scores to an objective mobile balance measurement tool. Materials & methods: Eighty-two athletes completed simultaneous balance testing using mBESS and the King–Devick Balance Test, an objective balance measurement tool. Errors on mBESS and objective measurements in the double-leg, single-leg (SS) and tandem stances were compared. Results: Mean mBESS error score was 7.23 ± 4.65. The SS accounted for 74% of errors and 21% of athletes demonstrated the maximum error score. There was no significant correlation between mBESS score and objective balance score. Conclusion: The high variability and large number of errors in the SS raises concerns over the utility of the SS in identifying suspected concussion

Is Noninvasive Vagus Nerve Stimulation a Safe and Effective Alternative to Medication for Acute Migraine Control?

BACKGROUND: Noninvasive neuromodulation devices have been used for a variety of headache disorders, including cluster and migraine, since recently being cleared by the Federal Drug Administration. Although these devices have been touted as low-risk options for improved headache control, the data behind actual efficacy endpoints remain unclear. OBJECTIVE: To critically assess current evidence regarding the efficacy of the noninvasive vagus nerve stimulator (nVNS) device for acute migraine management. METHODS: The objective was addressed through the development of a structured critically appraised topic. This included a clinical scenario with a clinical question, literature search strategy, critical appraisal, results, evidence summary, commentary, and bottom line conclusions.Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of headache. RESULTS: A randomized, double-blind, sham-controlled clinical trial was selected for critical appraisal. In this trial, the primary endpoint (pain freedom at 120 min after use of nVNS for first acute migraine attack) was not met when compared with sham device (30.4% for nVNS vs. 19.7% for sham; P=0.067). However, there were statistically significant differences found for various secondary endpoints favoring nVNS, such as pain freedom rates at 30 and 60 minutes, pain relief at 120 minutes, and mean percentage pain score reduction rates at 60 and 120 minutes. CONCLUSIONS: When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis. nVNS is likely a safe alternative to medications

Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial

Abstract Background Eptinezumab demonstrated efficacy in adults with migraine and prior preventive treatment failures in the placebo-controlled phase of the DELIVER clinical trial; its long-term effectiveness in this population has not yet been reported. The objective of this study was to evaluate the long-term effectiveness of eptinezumab in a migraine patient population during the 48-week extension phase of DELIVER. Methods DELIVER was conducted June 1, 2020 to September 15, 2022. 865 adults with migraine, with documented evidence of 2–4 prior preventive migraine treatment failures and with completion of the 24-week placebo-controlled period of DELIVER received eptinezumab (100 or 300 mg) during the dose-blinded extension, either continuing their randomized dose or, if originally receiving placebo, were randomized 1:1 to an eptinezumab dose (100 or 300 mg). A mixed model for repeated measures was used to evaluate changes from baseline in the number of monthly migraine days (MMDs). Results Of 865 patients entering the extension (eptinezumab 100 mg, n = 433; 300 mg, n = 432), 782 (90.4%) completed and 11 (1.3%) discontinued due to an adverse event. Eptinezumab was associated with early and sustained reductions in migraine frequency. Mean MMDs at baseline were approximately 14 days across groups. Mean (standard error) change from baseline in MMDs over the final dosing interval (weeks 61–72) was −6.4 (0.50) with placebo/eptinezumab 100 mg, –7.3 (0.49) with placebo/eptinezumab 300 mg, –7.1 (0.39) with eptinezumab 100 mg, and −7.0 (0.39) with eptinezumab 300 mg. During weeks 61–72, 63–70% of patients demonstrated ≥ 50% reduction in MMDs, and 36–45% demonstrated ≥ 75% reduction. Headache severity and acute medication use reductions, and patient-reported improvements in most bothersome symptom, disease status, quality of life, and work productivity, were observed. Adverse events were generally mild, transient, and similar in frequency/type to previous eptinezumab trials. Conclusions The long-term effectiveness and safety/tolerability of eptinezumab in patients with migraine and 2–4 prior preventive treatment failures was demonstrated by high completion rates and migraine-preventive benefits sustained for up to 18 months, implying that eptinezumab is a viable long-term treatment option for patients still seeking successful migraine treatments. Trial registration ClinicalTrials.gov (Identifier: NCT04418765; URL: https://www.clinicaltrials.gov/ct2/show/NCT04418765 ); EudraCT (Identifier: 2019-004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25 ). Graphical Abstrac

Supplementary Table 2 -Supplemental material for A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

<p>Supplemental material, Supplementary Table 2 for A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study) by Amaal J Starling, Stewart J Tepper, Michael J Marmura, Ejaz A Shamim, Matthew S Robbins, Nada Hindiyeh, Andrew C Charles, Peter J Goadsby, Richard B Lipton, Stephen D Silberstein, Amy A Gelfand, Richard P Chiacchierini and David W Dodick in Cephalalgia</p

Supplementary Table 1 -Supplemental material for A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

<p>Supplemental material, Supplementary Table 1 for A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study) by Amaal J Starling, Stewart J Tepper, Michael J Marmura, Ejaz A Shamim, Matthew S Robbins, Nada Hindiyeh, Andrew C Charles, Peter J Goadsby, Richard B Lipton, Stephen D Silberstein, Amy A Gelfand, Richard P Chiacchierini and David W Dodick in Cephalalgia</p