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Exploring the alterations in microstate dynamics during the migraine cycle and detecting pre-ictal phases. 探索偏头痛周期中微观状态动力学的变化,并检测孕前阶段。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-07-31 DOI: 10.1111/head.15031
Siyuan Xie, Yunyun Huo, Xinyi Geng, Li Hu, Ran Ao, Hui Su, Desheng Li, Miaomiao Hu, Yusha Liu, Xiaomei Chen, Jinghuan Liu, Qianqian Li, Jiayin Lin, Shengyuan Yu, Zhao Dong

Background: Microstate analysis captures brief but critical fluctuations in brain activity, making it a powerful tool for exploring the cyclic nature of migraine. In this study, we aimed to investigate microstate features during different migraine phases and develop a classification model to identify the pre-ictal phase.

Methods: From May 2023 to June 2024, we conducted a cross-sectional study with consecutive recruitment, collecting resting-state electroencephalography data from 174 individuals with migraine without aura and 50 healthy controls, followed by classification of migraine phases. Microstate features, Lempel-Ziv complexity, and sample entropy were compared across five groups. A model was developed to identify the pre-ictal phase and validated on a test set.

Results: Microstate features, particularly for microstates A and B, exhibited dynamic changes across the migraine cycle. The duration of microstate A was significantly longer in the inter-ictal phase than in the pre-ictal phase, whereas microstate B showed prolonged duration in the pre-ictal phase compared to healthy controls and the post-ictal phase. Microstate A displayed reduced coverage in the pre-ictal phase, whereas microstate B had increased occurrence and coverage during the pre-ictal and ictal phases. Transition probabilities also varied significantly: the pre-ictal phase showed elevated transitions from microstates A, C, and D to B, and the post-ictal phase showed reduced transitions from C and D to A. A classification model based on these microstate features achieved an area under the receiver operating characteristic curve (AUROC) of 0.85 (0.73-0.95), an area under the precision-recall curve (AUPRC) of 0.83 (0.66-0.95), and an F1 score of 0.78 (0.62-0.90) in the training set; and an AUROC of 0.84 (0.69-0.97), an AUPRC of 0.86 (0.67-0.98), and an F1 score of 0.81 (0.65-0.93) in the test set, indicating robust performance in identifying the pre-ictal phase.

Conclusion: Through the observation of cyclic alterations in the microstates of patients with migraine, we identified a reduction in microstate A and an enhancement in microstate B during the pre-ictal phase. These changes may indicate a heightened sensitivity to auditory stimuli and increased activity in the visual cortex, providing new insights into migraine pathophysiology. Our model effectively identified the pre-ictal phase, offering a promising approach for early intervention in migraine attacks.

背景:微观状态分析捕捉大脑活动短暂但关键的波动,使其成为探索偏头痛周期性的有力工具。在这项研究中,我们旨在研究偏头痛不同阶段的微观状态特征,并建立一个分类模型来识别孕前阶段。方法:从2023年5月至2024年6月,我们进行了一项连续招募的横断面研究,收集174名无先兆偏头痛患者和50名健康对照者的静息状态脑电图数据,并对偏头痛分期进行分类。微观状态特征、Lempel-Ziv复杂性和样本熵在五组之间进行了比较。开发了一个模型来识别临界前阶段,并在测试集上进行了验证。结果:微状态特征,特别是微状态A和微状态B,在整个偏头痛周期中表现出动态变化。微状态A在峰间期的持续时间明显长于峰前期,而微状态B在峰前期和峰后期的持续时间明显长于健康对照组。微状态A在孕前阶段的覆盖率降低,而微状态B在孕前和孕后阶段的发生率和覆盖率都有所增加。过渡概率也存在显著差异:在微状态A、C、D向B过渡的过程中,在微状态A、C、D向A过渡的过程中,在微状态A的过渡过程中,在微状态A的过渡过程中,在微状态A的过渡过程中,在微状态A的过渡过程中,在微状态A的过渡过程中,在微状态A的过渡过程中,基于微状态A的分类模型在接收者工作特征曲线下的面积(AUROC)为0.85(0.73-0.95),在精确召回曲线下的面积(AUPRC)为0.83 (0.66-0.95),F1得分为0.78 (0.62-0.90);AUROC为0.84 (0.69-0.97),AUPRC为0.86 (0.67-0.98),F1得分为0.81(0.65-0.93),表明该方法在识别临界前期具有较强的性能。结论:通过观察偏头痛患者微状态的周期性变化,我们发现在孕前阶段微状态a的减少和微状态B的增强。这些变化可能表明对听觉刺激的敏感性提高,视觉皮层活动增加,为偏头痛病理生理学提供了新的见解。我们的模型有效地识别了孕前阶段,为偏头痛发作的早期干预提供了一个有希望的方法。
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引用次数: 0
Three years of remote electrical neuromodulation (REN) acute treatment for migraine shows consistent effectiveness and no tachyphylaxis phenomenon. 三年的远程电神经调节(REN)急性治疗偏头痛显示一致的有效性和无快速反应现象。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-10-16 DOI: 10.1111/head.15069
Stephanie J Nahas, Marius Birlea, Alit Stark-Inbar, Sharon Shmuely, Eden Mama, Alon Ironi, William B Young, Alan M Rapoport
<p><strong>Objective: </strong>The current study aimed to evaluate the remote electrical neuromodulation (REN) wearable device over 3 years, assessing the potential for tachyphylaxis, consistent effectiveness, overall utilization patterns, and safety.</p><p><strong>Background: </strong>Migraine is a highly prevalent chronic neurological disease, especially during peak years of productivity, requiring ongoing management to prevent and reduce its disability. Traditional treatments often face challenges with long-term adherence due to waning efficacy, side effects, and medication interactions. REN offers a nonpharmacological approach for acute and preventive migraine treatment.</p><p><strong>Methods: </strong>This prospective real-world cohort study analyzed data from 224 patients with migraine in the United States who consistently treated their migraine attacks with the REN wearable device for 3 years between December 2019 and September 2024. The primary endpoint was defined as lack of tachyphylaxis, aka an increase of no more than 2.5 intensity units on a scale of 100 units between 2 consecutive years, representing a nonclinically meaningful change in treatment intensity over 3 years. Secondary endpoints were consistent effectiveness in at least 50% of treatments and consistent utilization, compared over 3 years. The safety outcome assessed the proportion of users with device-related adverse events (dAEs) and the severity and seriousness of the dAEs.</p><p><strong>Results: </strong>Over 3 years, there was no clinically meaningful change in treatment intensity, and the average (± standard deviation, SD) change between 2 consecutive years was no more than 2.5 intensity units (1.8 ± 5.5 between years 1 and 2, and 1.4 ± 5.3 between years 2 and 3; p = 0.120, McNemar test for two related dichotomous variables), indicating no tachyphylaxis. Effectiveness endpoints remained consistent over 3 years of treated attacks (generalized linear mixed model of repeated measures categorical data) with no significant differences over the 3 years: 72.1%-76.8% of users reporting pain relief (p = 0.846), 26.8%-28.7% pain freedom (p = 0.966), 65.3%-70.8% functional disability relief (p = 0.749), 31.4%-38.9% functional disability freedom (p = 0.680), 29.0%-37.0% freedom from photophobia (p = 0.590), 37.9%-49.4% freedom from phonophobia (p = 0.534), and 57.1%-66.7% freedom from nausea/vomiting (p = 0.753). Monthly utilization was consistent, ranging between 8.0 and 8.8 treatments per month, suggesting sustained adherence to therapy (p = 0.337, generalized linear model of repeated measures). Only two (0.9%) expected, nonserious dAEs were reported (mild or moderate localized skin reactions), neither leading to treatment discontinuation.</p><p><strong>Conclusion: </strong>This study demonstrates the long-term safety, consistent utilization, and acute treatment effectiveness, with no tachyphylaxis, in patients with migraine consistently treating with REN for 3 years. This sugg
目的:本研究旨在对远程电神经调节(REN)可穿戴设备进行为期3年的评估,评估其快速反应的潜力、一致的有效性、总体使用模式和安全性。背景:偏头痛是一种非常普遍的慢性神经系统疾病,特别是在生产力高峰期,需要持续的管理来预防和减少其残疾。由于疗效下降、副作用和药物相互作用,传统治疗经常面临长期坚持的挑战。REN为急性和预防性偏头痛治疗提供了一种非药物方法。方法:这项前瞻性现实世界队列研究分析了224名美国偏头痛患者的数据,这些患者在2019年12月至2024年9月期间持续使用REN可穿戴设备治疗偏头痛发作。主要终点被定义为缺乏快速反应,即连续2年间在100个单位的范围内增加不超过2.5个强度单位,代表3年内治疗强度的无临床意义的变化。次要终点是与3年相比,至少50%的治疗效果一致,使用率一致。安全性结果评估了发生器械相关不良事件(dAEs)的用户比例以及dAEs的严重程度和严重性。结果:3年内,治疗强度无临床意义变化,连续2年平均(±标准差,SD)变化不大于2.5强度单位(1 ~ 2年1.8±5.5,2 ~ 3年1.4±5.3;两相关二分类变量McNemar检验p = 0.120),无快速反应。疗效终点在治疗发作的3年内保持一致(重复测量分类数据的广义线性混合模型),3年内无显著差异:72.1% ~ 76.8%的使用者报告疼痛缓解(p = 0.846)、26.8% ~ 28.7%的疼痛缓解(p = 0.966)、65.3% ~ 70.8%的功能障碍缓解(p = 0.749)、31.4% ~ 38.9%的功能障碍缓解(p = 0.680)、29.0% ~ 37.0%的畏光缓解(p = 0.590)、37.9% ~ 49.4%的声音恐惧症缓解(p = 0.534)、57.1% ~ 66.7%的恶心/呕吐缓解(p = 0.753)。每月的使用率是一致的,在每月8.0到8.8次治疗之间,表明持续坚持治疗(p = 0.337,重复测量的广义线性模型)。只有两例(0.9%)预期的非严重dAEs报告(轻度或中度局部皮肤反应),均未导致停止治疗。结论:本研究证明了REN治疗偏头痛患者3年的长期安全性、一致性使用和急性治疗效果,无快速反应。这表明REN为偏头痛患者提供了一种有效、耐受性良好、安全和可持续的长期治疗选择。
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引用次数: 0
What's in the pipeline for pediatric headache treatment? 儿科头痛的治疗方案有哪些?
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-22 DOI: 10.1111/head.70037
Amy A Gelfand, Christina L Szperka
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引用次数: 0
No differences in subcortical volume between people with and without migraine: A REFORM study. 有和没有偏头痛的人的皮质下体积没有差异:一项改革研究。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-14 DOI: 10.1111/head.70001
Basit Ali Chaudhry, Rune Häckert Christensen, Håkan Ashina, Haidar Muhsen Al-Khazali, Tariq Mohammad Amin, Messoud Ashina, Faisal Mohammad Amin

Objectives/background: To determine whether the volume of specific subcortical structures differ between people with migraine and healthy controls, and whether these volumes vary across distinct migraine subtypes and phases. Subcortical structures, including regions involved in pain processing and sensory integration, play a key role in migraine pathophysiology, yet studies on volumetric differences have shown conflicting results. This study uses a large cohort and robust imaging methods to clarify whether subcortical volumes differ in migraine.

Methods: In this cross-sectional study at the Danish Headache Center in Denmark, conducted between January 2020 and December 2023, adult participants with migraine and age- and sex-matched healthy controls underwent a single magnetic resonance imaging session at 3T. T1-weigthed scans were acquired to measure the volumes of subcortical structures using automated segmentation techniques. The structures analyzed included the thalamus, putamen, caudate nucleus, pallidum, nucleus accumbens, amygdala, and hippocampus.

Results: Imaging data from 295 participants and 154 healthy controls were included in the final analyses. No significant differences were observed between participants with migraine and healthy controls in thalamic volume (migraine: 7243 ± 923 mm3 vs. healthy controls: 7350 ± 782 mm3; p = 0.774) or hippocampal volume (migraine: 4204 ± 398 mm3 vs. healthy controls: 4307 ± 446 mm3; p = 0.337). No differences were observed in any other subcortical structure. Likewise, different subgroup analyses revealed no volumetric differences in episodic versus chronic migraine, migraine with aura versus without aura, ictal versus headache free, or between each migraine subgroup and healthy controls (all p > 0.05 after multiple comparison correction).

Conclusion: In this large cross-sectional study, we found no evidence of subcortical volume differences between adults with migraine and healthy controls. Furthermore, no differences were found across migraine subtypes or phases. These findings indicate that subcortical volumetric measures are not suitable as imaging biomarkers of migraine. Future research should explore functional and metabolic alterations in subcortical structures to better understand the neurobiologic underpinnings of migraine.

目的/背景:确定特定皮质下结构的体积在偏头痛患者和健康对照者之间是否存在差异,以及这些体积在不同的偏头痛亚型和阶段是否存在差异。皮层下结构,包括涉及疼痛处理和感觉整合的区域,在偏头痛病理生理中起着关键作用,然而关于体积差异的研究显示了相互矛盾的结果。本研究采用大队列和强大的成像方法来澄清偏头痛的皮质下体积是否不同。方法:在2020年1月至2023年12月期间在丹麦丹麦头痛中心进行的这项横断面研究中,患有偏头痛的成年参与者和年龄和性别匹配的健康对照者在3T时接受了单次磁共振成像。使用自动分割技术获得t1加权扫描以测量皮质下结构的体积。分析的结构包括丘脑、壳核、尾状核、苍白球、伏隔核、杏仁核和海马。结果:295名参与者和154名健康对照者的影像学数据被纳入最终分析。偏头痛患者和健康对照者在丘脑体积(偏头痛:7243±923 mm3 vs健康对照:7350±782 mm3; p = 0.774)或海马体积(偏头痛:4204±398 mm3 vs健康对照:4307±446 mm3; p = 0.337)上没有观察到显著差异。在任何其他皮质下结构中未观察到差异。同样,不同的亚组分析显示,发作性偏头痛与慢性偏头痛、先兆偏头痛与无先兆偏头痛、发作性偏头痛与无头痛、每个偏头痛亚组与健康对照组之间的体积没有差异(经多次比较校正后,所有p < 0.05)。结论:在这项大型横断面研究中,我们没有发现成人偏头痛患者和健康对照者皮质下体积差异的证据。此外,没有发现偏头痛亚型或阶段之间的差异。这些发现表明皮质下体积测量不适合作为偏头痛的成像生物标志物。未来的研究应该探索皮质下结构的功能和代谢变化,以更好地了解偏头痛的神经生物学基础。
{"title":"No differences in subcortical volume between people with and without migraine: A REFORM study.","authors":"Basit Ali Chaudhry, Rune Häckert Christensen, Håkan Ashina, Haidar Muhsen Al-Khazali, Tariq Mohammad Amin, Messoud Ashina, Faisal Mohammad Amin","doi":"10.1111/head.70001","DOIUrl":"10.1111/head.70001","url":null,"abstract":"<p><strong>Objectives/background: </strong>To determine whether the volume of specific subcortical structures differ between people with migraine and healthy controls, and whether these volumes vary across distinct migraine subtypes and phases. Subcortical structures, including regions involved in pain processing and sensory integration, play a key role in migraine pathophysiology, yet studies on volumetric differences have shown conflicting results. This study uses a large cohort and robust imaging methods to clarify whether subcortical volumes differ in migraine.</p><p><strong>Methods: </strong>In this cross-sectional study at the Danish Headache Center in Denmark, conducted between January 2020 and December 2023, adult participants with migraine and age- and sex-matched healthy controls underwent a single magnetic resonance imaging session at 3T. T1-weigthed scans were acquired to measure the volumes of subcortical structures using automated segmentation techniques. The structures analyzed included the thalamus, putamen, caudate nucleus, pallidum, nucleus accumbens, amygdala, and hippocampus.</p><p><strong>Results: </strong>Imaging data from 295 participants and 154 healthy controls were included in the final analyses. No significant differences were observed between participants with migraine and healthy controls in thalamic volume (migraine: 7243 ± 923 mm<sup>3</sup> vs. healthy controls: 7350 ± 782 mm<sup>3</sup>; p = 0.774) or hippocampal volume (migraine: 4204 ± 398 mm<sup>3</sup> vs. healthy controls: 4307 ± 446 mm<sup>3</sup>; p = 0.337). No differences were observed in any other subcortical structure. Likewise, different subgroup analyses revealed no volumetric differences in episodic versus chronic migraine, migraine with aura versus without aura, ictal versus headache free, or between each migraine subgroup and healthy controls (all p > 0.05 after multiple comparison correction).</p><p><strong>Conclusion: </strong>In this large cross-sectional study, we found no evidence of subcortical volume differences between adults with migraine and healthy controls. Furthermore, no differences were found across migraine subtypes or phases. These findings indicate that subcortical volumetric measures are not suitable as imaging biomarkers of migraine. Future research should explore functional and metabolic alterations in subcortical structures to better understand the neurobiologic underpinnings of migraine.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"494-501"},"PeriodicalIF":4.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145512729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment of abdominal migraine in an 8-year-old child with calcitonin gene-related peptide receptor antagonist: A case report. 降钙素基因相关肽受体拮抗剂治疗8岁儿童腹部偏头痛1例。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-10 DOI: 10.1111/head.70017
Yunzhu Tang, Chunyan Lu, Yao Zhou, Shuxia Qian
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引用次数: 0
Routine migraine screening as a standard of care for Women's health: A position statement from the American Headache Society. 例行偏头痛筛查作为妇女健康护理的标准:美国头痛协会的立场声明。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-10 DOI: 10.1111/head.70023
Todd J Schwedt, Amaal J Starling, Jessica Ailani, Andrew D Hershey, Hope L O'Brien, Elizabeth Seng, Adam S Sprouse-Blum, Scott B Turner, Richard B Lipton

Objectives: The aim of this work was to develop an American Headache Society position statement addressing diagnostic screening for migraine among girls and women.

Background: Despite its high prevalence and substantial negative impacts, migraine is underdiagnosed and undertreated. Diagnostic screening for migraine enables more patients to receive timely, appropriate, and effective management.

Methods: Development of this position statement followed the rules established by the American Headache Society Guidelines Committee. The published literature was reviewed to determine if migraine meets criteria for when disease screening is justified, to guide recommendations for screening tools, and to determine subpopulation(s) for which migraine screening is indicated. After author consensus was reached, the position statement was reviewed and approved by the American Headache Society Board of Directors.

Results: Migraine fulfills established criteria for conditions in which screening is appropriate since it is highly prevalent, results in significant morbidity, and exerts substantial economic and social costs. Migraine incidence and prevalence are exceptionally high among girls and women during adolescence and through menopause. Furthermore, there are valid and reliable diagnostic screening methods (e.g., ID Migraine) and effective treatments that reduce migraine symptoms and disease impact.

Conclusion: Yearly diagnostic screening for migraine should be included as part of women's preventive healthcare services, particularly from adolescence to menopause.

目的:这项工作的目的是制定美国头痛协会的立场声明,解决女孩和妇女偏头痛的诊断筛查。背景:尽管偏头痛的高患病率和巨大的负面影响,但它的诊断和治疗不足。偏头痛的诊断筛查使更多的患者得到及时、适当和有效的治疗。方法:根据美国头痛协会指南委员会制定的规则制定本立场声明。回顾已发表的文献,以确定偏头痛是否符合疾病筛查的标准,指导筛查工具的推荐,并确定偏头痛筛查的亚人群。在作者达成共识后,立场声明由美国头痛协会董事会审查并批准。结果:偏头痛符合既定条件,筛查是适当的,因为它是高度普遍的,导致显著的发病率,并产生巨大的经济和社会成本。在青春期和绝经期的女孩和妇女中,偏头痛的发病率和流行率特别高。此外,有有效和可靠的诊断筛选方法(例如,ID偏头痛)和有效的治疗方法可以减少偏头痛症状和疾病影响。结论:偏头痛的年度诊断筛查应作为妇女预防性保健服务的一部分,特别是从青春期到更年期。
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引用次数: 0
Revisiting the mechanism of intranasal lidocaine: Evidence beyond sphenopalatine ganglion block. 重新审视鼻内利多卡因的作用机制:超越蝶腭神经节阻滞的证据。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2026-01-15 DOI: 10.1111/head.70029
Hsiangkuo Yuan, Samer Narouze
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引用次数: 0
Navigating the patient journey in migraine prevention: An American Migraine Foundation position paper. 在偏头痛预防的病人旅程中导航:美国偏头痛基金会的立场文件。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-10-03 DOI: 10.1111/head.15062
Lawrence C Newman, Christine Lay, Richard B Lipton, Jessica Ailani, Kathleen B Digre, Arthur Caplan, Nim Singh, Heather Phillips, Rachel Koh, Royce Warrick, David W Dodick
<p><strong>Objective: </strong>This study aimed to understand the factors limiting access to medications for the preventive treatment of migraine and to improve access to evidence-based preventive care.</p><p><strong>Background: </strong>For decades, the effective use of medication for the preventive treatment of migraine was limited by slow onset, slow and complex dose titration schedules, modest benefits, drug interactions, frequent side effects, and very low long-term adherence. The calcitonin gene-related peptide (CGRP) targeted preventive medications mitigate some of these limitations and demonstrated substantial therapeutic benefits in a significant proportion of adults with migraine. The American Headache Society considers these medications among the first-line options for migraine prevention, although access to them remains limited. The American Migraine Foundation hosted a single-day, multidisciplinary expert panel discussion to identify barriers to optimal preventive care and developed recommendations to address them.</p><p><strong>Methods: </strong>Participants identified and prioritized barriers and used a modified nominal group technique to achieve consensus on them. A series of moderated discussions in plenary and breakout sessions was used to create possible solutions. Modified nominal group technique was also employed to achieve consensus on the priorities among these barriers and to achieve whole-group consensus on the recommendations. Ethical issues that inform access were discussed.</p><p><strong>Results: </strong>Participants included eight neurologists and board-certified headache specialists, six representatives of reimbursement decision-makers, six employees of life sciences companies, four patient advocates with lived experience with migraine, and a medical ethicist. Among those who have consulted healthcare professionals and received a diagnosis of migraine, we identified four main barriers to accessing preventive treatment: restrictive prior authorization requirements, the perceived lack of real-world evidence and treatment guidelines, the need for clinician education, and the need for patient education. Consensus recommendations for eliminating barriers centered on using new evidence to evaluate policies that restrict the selection of first-line therapies, initiating/improving collaboration among stakeholders, sharing of data and best practices, and increased training. Participants agreed to explore novel definitions of the value of preventive treatment and to establish the Migraine Prevention Network to facilitate ongoing cooperation and collective action. However, due to financial limitations, staffing changes, and time constraints, post-meeting discussions led to a shift from establishing a broad Migraine Prevention Network to forming smaller task forces focused on the top-priority barriers (real-world evidence and The Patient Playbook) identified through collaborative voting among American Headache Society, American
目的:本研究旨在了解限制偏头痛预防治疗药物可及性的因素,并改善循证预防保健的可及性。背景:几十年来,偏头痛预防性治疗药物的有效使用受到发病缓慢、缓慢和复杂的剂量滴定方案、适度的益处、药物相互作用、频繁的副作用和非常低的长期依从性的限制。降钙素基因相关肽(CGRP)靶向预防药物减轻了这些局限性,并在相当大比例的成人偏头痛患者中显示出实质性的治疗效果。美国头痛协会认为这些药物是预防偏头痛的一线选择,尽管获得这些药物的途径仍然有限。美国偏头痛基金会举办了为期一天的多学科专家小组讨论,以确定最佳预防保健的障碍,并提出解决这些障碍的建议。方法:参与者识别和优先考虑障碍,并使用改进的名义群体技术来达成共识。在全体会议和分组会议上进行了一系列主持的讨论,以制定可能的解决方案。还采用了改良的名义小组技术,以便就这些障碍的优先事项达成协商一致意见,并就建议达成全体协商一致意见。讨论了信息获取的伦理问题。结果:参与者包括8名神经科医生和委员会认证的头痛专家,6名报销决策者代表,6名生命科学公司员工,4名有偏头痛生活经验的患者倡导者和1名医学伦理学家。在那些咨询过医疗保健专业人员并被诊断为偏头痛的患者中,我们确定了获得预防性治疗的四个主要障碍:限制性事先授权要求,感知到缺乏真实证据和治疗指南,临床医生教育的需要,以及患者教育的需要。消除障碍的共识建议集中在使用新的证据来评估限制一线疗法选择的政策,启动/改善利益相关者之间的合作,共享数据和最佳实践,以及增加培训。与会者同意探讨预防性治疗价值的新定义,并建立偏头痛预防网络,以促进正在进行的合作和集体行动。然而,由于财政限制、人员变动和时间限制,会议后的讨论导致从建立一个广泛的偏头痛预防网络转变为通过美国头痛协会、美国偏头痛基金会和行业利益相关者之间的协作投票确定的更小的工作组,重点关注最优先的障碍(现实世界的证据和患者手册)。结论:成人偏头痛患者在获得新的偏头痛特异性、cgrp靶向预防治疗方面面临多重障碍。提供医疗服务的利益相关者,包括临床医生、报销决策者、生命科学公司以及患者和临床医生的倡导者,可能能够克服许多这些障碍,并通过与患者合作并代表患者改善可及性。
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引用次数: 0
Partial rebreathing is not effective for early treatment of migraine with aura attacks: Results of a double-blind, randomized, controlled trial (PAREMA1). 部分再呼吸对先兆发作偏头痛的早期治疗无效:一项双盲、随机、对照试验(PAREMA1)的结果。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-11-21 DOI: 10.1111/head.15090
Charly Gaul, Sónia Ferreira, Troels Johansen

Objective: Evaluate the efficacy and safety of a novel partial rebreathing device for early treatment of acute attacks of migraine with aura.

Background: Earlier clinical studies have indicated a potential for CO2-enriched gas to be effective for acute treatment of migraine with aura, especially when applied during the early part of the aura stage. We developed a partial rebreathing device inducing moderate, steady-state hypercapnia with normoxia in order to provide a carbon dioxide delivery system combining efficacy, usability, safety, and affordability.

Methods: This randomized, double-blind, sham-controlled, parallel-group, group-sequential study was conducted at 15 study sites, nine located in the United States and six in Germany, between March 2023 and February 2025. The study enrolled patients aged 18-65 years with migraine with aura. The study had a sequential two-stage study design. At the beginning of stage 1, participants were randomized to active or sham and treated up to four attacks. Participants were instructed to treat from the onset of aura and until 5 min after aura cessation. After having reported four attacks in stage 1, participants had the option to continue into stage 2, an open-label extension in which they could treat up to five attacks with the active device. During stage 1, participants recorded symptom scores in a study diary app at the onset of aura and after 1, 2, 24, and 48 h.

Results: The study was terminated at the interim analysis point due to the lack of effect, at which point 142 participants had been enrolled (mean age 39.2 years, 81% women [115/142]). Sixty-seven participants had reported at least one study attack by the time of the study termination. None of the primary or secondary endpoints reached statistical significance. The primary endpoint Absence of Moderate or Severe Pain at 2 hours was 69.7% (46/66) [95.2% confidence interval (CI), 48.5, 90.9] in the sham group and 60.0% (42/70) [95.2% CI, 37.6, 82.4] in the active group (p = 0.379), whereas Pain Freedom at 2 hours was 18.2% (12/66) [95.2% CI, 1.3, 35.1] in the sham group and 21.4% (15/70) [95.2% CI, 3.6, 39.2] in the active group (p = 0.717).

Conclusion: Partial rebreathing inducing moderate hypercapnia with normoxia was not effective for aura-stage treatment of migraine-with-aura attacks. The study was preregistered at ClinicalTrials.gov (registration number NCT05546385).

目的:评价一种新型部分再呼吸装置早期治疗先兆偏头痛急性发作的疗效和安全性。背景:早期的临床研究表明,富含二氧化碳的气体可能对先兆偏头痛的急性治疗有效,特别是在先兆期的早期应用。我们开发了一种局部再呼吸装置,诱导中度、稳态高碳酸血症伴常氧,以提供一种有效、可用、安全和可负担的二氧化碳输送系统。方法:这项随机、双盲、假对照、平行组、组序研究于2023年3月至2025年2月在15个研究地点进行,其中9个位于美国,6个位于德国。该研究招募了18-65岁的先兆偏头痛患者。该研究采用连续两阶段的研究设计。在第一阶段开始时,参与者被随机分为积极组和假组,最多接受四次攻击。参与者被指示从先兆开始到先兆停止后5分钟进行治疗。在第一阶段报告了四次攻击后,参与者可以选择继续进入第二阶段,这是一个开放标签扩展,他们可以使用活动设备治疗多达五次攻击。在第一阶段,参与者在先兆发作时以及1、2、24和48小时后在研究日记应用程序中记录症状评分。结果:由于缺乏效果,研究在中期分析点终止,此时已有142名参与者入组(平均年龄39.2岁,81%为女性[115/142])。在研究结束时,67名参与者报告了至少一次研究发作。主要和次要终点均无统计学意义。主要终点假手术组2小时中重度疼痛消失率为69.7%(46/66)[95.2%可信区间(CI), 48.5, 90.9],活动组为60.0% (42/70)[95.2% CI, 37.6, 82.4] (p = 0.379),而假手术组2小时疼痛解除率为18.2% (12/66)[95.2% CI, 1.3, 35.1],活动组为21.4% (15/70)[95.2% CI, 3.6, 39.2] (p = 0.717)。结论:部分再呼吸诱导中度高碳酸血症伴缺氧对先兆期偏头痛发作无疗效。该研究已在ClinicalTrials.gov预注册(注册号NCT05546385)。
{"title":"Partial rebreathing is not effective for early treatment of migraine with aura attacks: Results of a double-blind, randomized, controlled trial (PAREMA1).","authors":"Charly Gaul, Sónia Ferreira, Troels Johansen","doi":"10.1111/head.15090","DOIUrl":"10.1111/head.15090","url":null,"abstract":"<p><strong>Objective: </strong>Evaluate the efficacy and safety of a novel partial rebreathing device for early treatment of acute attacks of migraine with aura.</p><p><strong>Background: </strong>Earlier clinical studies have indicated a potential for CO<sub>2</sub>-enriched gas to be effective for acute treatment of migraine with aura, especially when applied during the early part of the aura stage. We developed a partial rebreathing device inducing moderate, steady-state hypercapnia with normoxia in order to provide a carbon dioxide delivery system combining efficacy, usability, safety, and affordability.</p><p><strong>Methods: </strong>This randomized, double-blind, sham-controlled, parallel-group, group-sequential study was conducted at 15 study sites, nine located in the United States and six in Germany, between March 2023 and February 2025. The study enrolled patients aged 18-65 years with migraine with aura. The study had a sequential two-stage study design. At the beginning of stage 1, participants were randomized to active or sham and treated up to four attacks. Participants were instructed to treat from the onset of aura and until 5 min after aura cessation. After having reported four attacks in stage 1, participants had the option to continue into stage 2, an open-label extension in which they could treat up to five attacks with the active device. During stage 1, participants recorded symptom scores in a study diary app at the onset of aura and after 1, 2, 24, and 48 h.</p><p><strong>Results: </strong>The study was terminated at the interim analysis point due to the lack of effect, at which point 142 participants had been enrolled (mean age 39.2 years, 81% women [115/142]). Sixty-seven participants had reported at least one study attack by the time of the study termination. None of the primary or secondary endpoints reached statistical significance. The primary endpoint Absence of Moderate or Severe Pain at 2 hours was 69.7% (46/66) [95.2% confidence interval (CI), 48.5, 90.9] in the sham group and 60.0% (42/70) [95.2% CI, 37.6, 82.4] in the active group (p = 0.379), whereas Pain Freedom at 2 hours was 18.2% (12/66) [95.2% CI, 1.3, 35.1] in the sham group and 21.4% (15/70) [95.2% CI, 3.6, 39.2] in the active group (p = 0.717).</p><p><strong>Conclusion: </strong>Partial rebreathing inducing moderate hypercapnia with normoxia was not effective for aura-stage treatment of migraine-with-aura attacks. The study was preregistered at ClinicalTrials.gov (registration number NCT05546385).</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"417-427"},"PeriodicalIF":4.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573405","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Remote electrical neuromodulation for reducing procedural pain in patients with chronic migraine receiving onabotulinumtoxinA injections: A randomized sham-controlled study. 远程电神经调节减少慢性偏头痛患者接受肉毒杆菌毒素注射的程序性疼痛:一项随机假对照研究。
IF 4 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-31 DOI: 10.1111/head.70032
Nan Cheng, Christopher C Anderson, Nan Zhang, Juliana H VanderPluym, Amaal J Starling

Background: OnabotulinumtoxinA (BoNT-A) is an established preventive treatment for chronic migraine but involves 31 to 40 injections per session, often causing discomfort and post-procedural headaches. Remote electrical neuromodulation (REN) is a noninvasive therapy with efficacy in migraine treatment via conditioned pain modulation but has not been evaluated for procedural pain. This study evaluated REN's effectiveness in reducing acute procedural pain and postprocedural headache associated with BoNT-A injections.

Methods: This was an investigator-initiated single-center, randomized, single-blind, sham-controlled crossover study enrolled 80 adults (aged 22 to 74 years) with chronic migraine undergoing routine BoNT-A treatment. Each participant received one injection session without a device, followed by sessions using active REN and sham in randomized order. REN was applied to the upper arm 10 min prior to injections and removed after injection completion. Pain intensity was measured using a visual analog scale (0 to 100) at pre-procedure, intra-procedure, and post-procedure time points. The primary outcome was procedural pain intensity, and secondary outcomes included post-procedural headache incidence and adverse events. Due to clear benefit, the study was terminated early based on predefined stopping criteria.

Results: Final analysis of 60 participants (mean age 48.0 years; 49/60, 82% female) demonstrated that pre-procedural pain levels were not significantly different between baseline and the active REN or sham (p > 0.999 and p = 0.485, respectively). However, during and after BoNT-A administration, the active REN group reported significantly lower pain scores compared to both the sham and baseline conditions. At intra-procedure, the REN group experienced a mean pain reduction of 15.0 points (p < 0.001), and at post-procedure experienced a 19.1-point reduction (p < 0.001). Sham treatment did not result in significant pain reduction compared to baseline (p > 0.999 for both intra-procedure and post-procedure). Additionally, REN lowered the incidence of headache as an adverse event, with only 15% (8/52) of participants experiencing post-procedural headache compared to 55% (29/53) in the sham group and 39% (23/59) at baseline (odds ratio = 0.28, 95% confidence interval: 0.10 to 0.69, p = 0.008). No additional adverse events were reported.

Conclusions: REN significantly reduces procedural pain and post-procedural headache associated with BoNT-A injections for chronic migraine and may serve as a noninvasive, easily implemented pain management strategy for acute procedural pain. REN represents a promising approach to improving patient comfort during routine migraine treatment as well as reducing post-procedural headache.

背景:OnabotulinumtoxinA (BoNT-A)是慢性偏头痛的预防性治疗方法,但每次需要注射31至40次,通常会引起不适和术后头痛。远程电神经调节(REN)是一种非侵入性治疗方法,通过条件疼痛调节治疗偏头痛有效,但尚未对程序性疼痛进行评估。本研究评估了REN在减少BoNT-A注射相关的急性手术疼痛和术后头痛方面的有效性。方法:这是一项研究者发起的单中心、随机、单盲、假对照交叉研究,纳入了80名接受常规BoNT-A治疗的慢性偏头痛患者(年龄22至74岁)。每个参与者接受一次不带器械的注射,随后按随机顺序使用主动REN和假药。REN在注射前10分钟应用于上臂,注射完成后取出。在手术前、手术中和手术后时间点,采用视觉模拟量表(0 - 100)测量疼痛强度。主要结局是手术疼痛强度,次要结局包括手术后头痛发生率和不良事件。由于获益明显,研究根据预先设定的停止标准提前终止。结果:60名参与者(平均年龄48.0岁;49/60,82%为女性)的最终分析表明,术前疼痛水平在基线和活动REN或假手术之间无显著差异(p > 0.999和p = 0.485)。然而,在BoNT-A给药期间和之后,与假手术和基线条件相比,活跃REN组报告的疼痛评分显着降低。在术中,REN组平均疼痛减轻15.0点(术中和术后p均为0.999)。此外,REN降低了头痛作为不良事件的发生率,只有15%(8/52)的参与者经历手术后头痛,而假手术组为55%(29/53),基线为39%(23/59)(优势比= 0.28,95%可信区间:0.10至0.69,p = 0.008)。没有其他不良事件的报道。结论:REN可显著减少慢性偏头痛患者注射BoNT-A相关的手术疼痛和术后头痛,可作为急性手术疼痛的一种无创、易于实施的疼痛管理策略。REN代表了一种有希望的方法,可以改善患者在常规偏头痛治疗期间的舒适度,并减少手术后头痛。
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引用次数: 0
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Headache
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