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Postmarketing safety of migraine prophylactic monoclonal antibodies: An EudraVigilance database analysis of eptinezumab, fremanezumab, galcanezumab, and erenumab. 偏头痛预防性单克隆抗体的上市后安全性:eptinezumab, fremanezumab, galcanezumab和erenumab的EudraVigilance数据库分析
IF 5.4 2区 医学
Headache Pub Date : 2025-05-29 DOI: 10.1111/head.14962
Victoria Nikitina, Greta Santi Laurini, Nicola Montanaro, Domenico Motola
{"title":"Postmarketing safety of migraine prophylactic monoclonal antibodies: An EudraVigilance database analysis of eptinezumab, fremanezumab, galcanezumab, and erenumab.","authors":"Victoria Nikitina, Greta Santi Laurini, Nicola Montanaro, Domenico Motola","doi":"10.1111/head.14962","DOIUrl":"https://doi.org/10.1111/head.14962","url":null,"abstract":"<p><strong>Objectives/background: </strong>This study was undertaken to evaluate the postmarketing safety of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide pathway used for migraine prophylaxis through pharmacovigilance data analysis by examining suspected adverse events reported in Europe. Migraine is one of the most prevalent and debilitating neurological disorders globally. The introduction of mAbs targeting the calcitonin gene-related peptide pathway has transformed migraine prophylaxis. However, their safety profiles in real-world settings are not fully established, and ongoing safety monitoring is essential, as clinical trials may not capture all potential adverse drug reactions associated with new therapies.</p><p><strong>Methods: </strong>A disproportionality analysis was carried out by analyzing postmarketing pharmacovigilance data from the EudraVigilance database, focusing on four mAbs: eptinezumab, fremanezumab, galcanezumab, and erenumab. Descriptive and statistical analyses were performed on data retrieved from the date of marketing authorization of each medicine up to June 16, 2024. The reporting odds ratio (ROR), information component, and empirical Bayes geometric mean were calculated to detect signals of disproportionate reporting comparing their safety profiles to topiramate, a standard preventive migraine treatment.</p><p><strong>Results: </strong>A total of 14,285 reports had emerged; most of them were from females and concerned patients aged 18-64 years. The most frequently reported adverse drug reactions were primarily nonserious, aligning with literature and previously established safety profiles, such as fatigue and injection site reactions. The statistical analysis revealed 15 significant disproportionality signals: 11 for eptinezumab and four for galcanezumab. Eptinezumab highlighted potential new safety signals such as palpitations (ROR = 6.93, 95% confidence interval [CI] = 3.39-14.18), oropharyngeal pain (ROR = 7.19, 95% CI = 3.40-15.24), and erythema (ROR = 12.31, 95% CI = 4.58-33.12). These findings suggest a potential class effect, warranting further investigations and highlighting the importance of continued monitoring regarding the long-term safety of mAbs.</p><p><strong>Conclusion: </strong>Almost all of the most reported and statistically significant adverse events were nonserious and consistent with the existing literature. Given the chronic nature of migraine treatment, continuous pharmacovigilance monitoring is essential to ensure their constant safe use in clinical practice.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173325","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 medication-overuse headache in children and adolescents: A systematic review. 儿童和青少年药物过度使用头痛的治疗:一项系统综述。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-29 DOI: 10.1111/head.14973
Juliana H VanderPluym, Nan Cheng, Ye Zhu, Zhen Wang, Cynthia Morris, Andrew Jones, Amy A Gelfand, Jesssica Gautreaux
{"title":"Treatment of medication-overuse headache in children and adolescents: A systematic review.","authors":"Juliana H VanderPluym, Nan Cheng, Ye Zhu, Zhen Wang, Cynthia Morris, Andrew Jones, Amy A Gelfand, Jesssica Gautreaux","doi":"10.1111/head.14973","DOIUrl":"https://doi.org/10.1111/head.14973","url":null,"abstract":"<p><strong>Objective: </strong>To examine the effectiveness of treatment strategies for medication-overuse headache (MOH) in children and adolescents.</p><p><strong>Background: </strong>There are no guidelines for the treatment of adult or pediatric patients with MOH. However, research pertaining to MOH in adults is far outpacing research in children and adolescents.</p><p><strong>Methods: </strong>A systematic review of evidence on treatment for MOH in children and adolescents was performed via PubMed, Embase, Web of Science, PsycINFO, and Cochrane from database inception to October 2024 for articles with the subject headings and keywords for MOH and pediatric, children, and/or adolescent. Inclusion criteria were: (i) randomized controlled trials and retrospective and prospective observational studies, (ii) children and adolescents aged <18 years with chronic headaches and with medication overuse (MO) or MOH, and (iii) interventions addressing MO or MOH, including pharmacologic and behavioral interventions. At least two independent reviewers screened citations and full-text articles independently.</p><p><strong>Results: </strong>A total of 16 studies (one randomized control trial, six prospective observational studies and nine retrospective observational studies) were identified as meeting final inclusion criteria, resulting in 7978 total participants with a subset of those having MO, MOH or probable MOH. Participants ranged in mean age from 10 to 14.7 years, with 7.1%-46.2% male participants. All the studies recruited patients from an outpatient setting. Interventions used in the studies included withdrawal of the overused acute medication, initiation of preventive medication, patient education, physiotherapy and psychological treatment, and motivational interviewing. Multimodal therapy was studied more than single therapeutic intervention. There was vast heterogeneity across the studies, including study design, diagnostic criteria, intervention type, and outcomes.</p><p><strong>Conclusion: </strong>From the data available, there does not seem to be a singular superior treatment approach. Accordingly, the most appropriate treatment modality will need to be tailored to the patient and their caregivers. Further research is required regarding management of MOH in children and adolescents.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173385","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
Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women. 健康哺乳期妇女单剂量增殖剂的乳和血浆药代动力学。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14960
Ramesh R Boinpally, Jonathan H Smith, Eric Cohen, Joel M Trugman
{"title":"Milk and plasma pharmacokinetics of single-dose ubrogepant in healthy lactating women.","authors":"Ramesh R Boinpally, Jonathan H Smith, Eric Cohen, Joel M Trugman","doi":"10.1111/head.14960","DOIUrl":"https://doi.org/10.1111/head.14960","url":null,"abstract":"<p><strong>Objective: </strong>The objectives of this study were to evaluate the safety, plasma and milk pharmacokinetics, excretion in breast milk, and the relative infant dose of ubrogepant following a single oral dose.</p><p><strong>Background: </strong>Ubrogepant is a calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. Preclinical findings in rats demonstrated comparable concentrations of ubrogepant in milk versus plasma; however, the quantification of ubrogepant excretion in human breast milk and breastfed infant exposure have not been previously evaluated.</p><p><strong>Methods: </strong>This open-label, phase 1 study (NCT05892757) enrolled healthy, lactating adult women from July 11, 2023, to February 22, 2024. Participants were 1-6 months postpartum and received a single dose of ubrogepant 100 mg (2 × 50 mg tablets) orally. Plasma and breast milk samples were collected for up to 24 h after dosing to evaluate pharmacokinetics and ubrogepant concentrations were determined using validated liquid chromatography tandem mass spectrometry assays. Standard pharmacokinetic parameters were calculated from the plasma concentration and breast milk data using non-compartmental analyses. The milk-to-plasma concentration ratio was calculated based on the ratio of the area under the plasma concentration-time curve from time 0 to infinity (AUC<sub>∞</sub>) of human milk to the AUC<sub>∞</sub> of plasma. The relative infant dose was calculated as 100 times the quotient of the body weight-normalized infant dose and the body weight-normalized maternal dose. Safety and tolerability were assessed via adverse events, vital signs, electrocardiograms, and clinical laboratory measurements.</p><p><strong>Results: </strong>A total of 12 women were enrolled who each received a single dose of oral ubrogepant 100 mg. The mean milk-to-plasma ratio was 0.23, the cumulative amount of ubrogepant excreted in breast milk was <0.02% and the calculated relative infant dose was 0.15%. The maximum observed breast milk concentration and AUC of ubrogepant in breast milk were significantly lower (75% and 78%, respectively) compared to plasma. Only two mild adverse events were reported.</p><p><strong>Conclusion: </strong>Less than 0.02 mg of a 100 mg dose of ubrogepant was excreted in breast milk over a 24-h period. The minimal transfer of ubrogepant into breast milk is not considered clinically relevant.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101765","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
The effect of different exercise types on migraine frequency in individuals with migraine: A pilot study. 不同运动类型对偏头痛患者偏头痛频率的影响:一项初步研究。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14951
Yunus Emre Meydanal, Seçkin Şenışık, Hadiye Şirin
{"title":"The effect of different exercise types on migraine frequency in individuals with migraine: A pilot study.","authors":"Yunus Emre Meydanal, Seçkin Şenışık, Hadiye Şirin","doi":"10.1111/head.14951","DOIUrl":"https://doi.org/10.1111/head.14951","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to evaluate the effects of different types and combinations of exercise on migraine attacks and accompanying comorbidities.</p><p><strong>Background: </strong>Combining aerobic and resistance exercises may yield more significant improvements in patients with migraine.</p><p><strong>Methods: </strong>This parallel-group randomized controlled study included 24 participants, who were then divided equally into three groups: an aerobic exercise group, a combined exercise group (aerobic and resistance exercises), and a control group. It was conducted at Ege University Hospital between September 2022 and March 2024. Following a 1-month baseline headache diary period, both intervention groups participated in the same aerobic exercises 3 days a week for 12 weeks. The combined exercise group performed five resistance exercises targeting the neck, upper back, and shoulder muscles alongside the aerobic exercises 3 days a week for 12 weeks. Measurements were taken at baseline, after the 3-month intervention period, and after a 2-month follow-up period. The primary outcome was the number of migraine headache days per month. Secondary outcomes included anxiety and depression levels, aerobic capacity, physical activity status, and migraine-related quality of life.</p><p><strong>Results: </strong>The number of migraine days per month significantly decreased in both the aerobic and combined exercise groups during the post-intervention period, while no significant change was observed in the control group (p < 0.001 for aerobic and combined exercise groups, p = 0.166 for control group). Migraine headache frequency showed a statistically significant decrease in the combined exercise group compared to the aerobic exercise group (p = 0.027). Additionally, both exercise groups showed significant improvements in aerobic capacity (p < 0.001 for both) and physical activity levels (p < 0.001 and p = 0.001, respectively) post-intervention, which were not observed in the control group (p = 0.747 for aerobic capacity, p = 0.05 for physical activity levels). Although no significant effect on depression scores was observed in either exercise group, anxiety scores significantly decreased in the combined exercise group from pre- to post-intervention (p = 0.037). Significant improvements in migraine-related quality of life were observed in both intervention groups (p = 0.018 and p = 0.001, respectively), with no significant difference (p = 0.934). Neither significant change was observed in depression and anxiety scores nor migraine-related quality of life in the control group (p = 0.593, p = 0.438 and 0.081 respectively).</p><p><strong>Conclusions: </strong>Aerobic and combined exercise groups showed a reduction in monthly migraine headache frequency without any side effects, with the reduction being statistically more significant in the combined exercise group.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101769","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
Mild cognitive impairment in spontaneous intracranial hypotension and its rapid reversal by repair of a spinal cerebrospinal fluid leak. 自发性颅内低血压的轻度认知障碍及其通过脊髓脑脊液泄漏修复的快速逆转。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14966
Katharina Wolf, Florian Volz, Amir El Rahal, M Overstijns, Niklas Lützen, Charlotte Zander, Mukesch J Shah, Horst Urbach, Jürgen Beck
{"title":"Mild cognitive impairment in spontaneous intracranial hypotension and its rapid reversal by repair of a spinal cerebrospinal fluid leak.","authors":"Katharina Wolf, Florian Volz, Amir El Rahal, M Overstijns, Niklas Lützen, Charlotte Zander, Mukesch J Shah, Horst Urbach, Jürgen Beck","doi":"10.1111/head.14966","DOIUrl":"https://doi.org/10.1111/head.14966","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109796","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
Validation of a Portuguese version of the four-item Migraine Interictal Burden Scale. 葡萄牙语版偏头痛四项间期负担量表的验证。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14958
Sofia Ferrão Malheiro, Filipa Dourado Sotero, Manuel Bragança Pereira, Beatriz Nunes Vicente, Roberto Luís Mendes Franco, Sofia Duardte Rodrigues Casanosa, Jorge Miguel Ramos Ferreira, Raquel Santos Gil Gouveia, Carlos Andrade, Isabel Pavão Martins
{"title":"Validation of a Portuguese version of the four-item Migraine Interictal Burden Scale.","authors":"Sofia Ferrão Malheiro, Filipa Dourado Sotero, Manuel Bragança Pereira, Beatriz Nunes Vicente, Roberto Luís Mendes Franco, Sofia Duardte Rodrigues Casanosa, Jorge Miguel Ramos Ferreira, Raquel Santos Gil Gouveia, Carlos Andrade, Isabel Pavão Martins","doi":"10.1111/head.14958","DOIUrl":"https://doi.org/10.1111/head.14958","url":null,"abstract":"<p><strong>Background: </strong>Migraine is the most common neurological disorder and the second leading cause of disability. While the impact of migraine on daily life is often assessed by the frequency and intensity of attacks, the impairment between episodes is frequently overlooked. The four-item Migraine Interictal Burden Scale (MIBS-4) is a tool that can provide information and help in the evaluation of interictal disability.</p><p><strong>Objective: </strong>To adapt and validate a translated version of the MIBS-4 for the Portuguese population.</p><p><strong>Methods: </strong>A prospective, multicentric observational study was conducted between July 2023 and February 2024 in six tertiary headache centers across Portugal. The MIBS-4 was translated and back-translated to obtain a consensus version. The scale was administered to 459 patients with migraine, and its psychometric properties were assessed through correlations with established measures, including the Migraine Disability Assessment Scale (MIDAS), 12-item Short Form Survey (SF-12), and Hospital Anxiety and Depression Scale (HADS).</p><p><strong>Results: </strong>A total of 459 patients were evaluated, including 430 women (93.7%), with an average age of 45.06 years. The MIBS-4 demonstrated good internal consistency with a Cronbach's alpha of 0.84 (95% confidence interval 0.81-0.86) and significant correlations with the MIDAS (r = 0.304, p < 0.001), SF-12 (r = 0.483, p < 0.001), and HADS (r = 0.211, p < 0.001), confirming its reliability and construct validity.</p><p><strong>Conclusion: </strong>This analysis showed that the Portuguese version of the MIBS-4 showed identical psychometric properties to the original scale and can effectively assess interictal disability in patients with migraine in Portuguese speaking populations. Its validation provides a valuable tool for clinical practice and research, enabling improved assessment of migraine burden and contributing to better patient care in lusophone countries.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101770","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
Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study. zavegepant 10mg鼻喷雾剂与抗降钙素基因相关肽单克隆抗体或其他选择性偏头痛预防药物的长期安全性和耐受性:来自一项2/3期开放标签研究的结果
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14954
Gary Berman, Kathleen Mullin, Timothy Smith, Linda Mosher, Samantha Sweeney, Robert J Fountaine
{"title":"Long-term safety and tolerability of zavegepant 10-mg nasal spray with concomitant use of anti-calcitonin gene-related peptide monoclonal antibodies or other select preventive migraine medications: Results from a phase 2/3 open-label study.","authors":"Gary Berman, Kathleen Mullin, Timothy Smith, Linda Mosher, Samantha Sweeney, Robert J Fountaine","doi":"10.1111/head.14954","DOIUrl":"https://doi.org/10.1111/head.14954","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate the safety and tolerability of zavegepant (ZAV) when used as needed for acute treatment of migraine in patients taking concomitant preventive migraine medications (anti-calcitonin gene-related peptide monoclonal antibodies [CGRP mAbs] or other select preventive migraine medications [OSPs]).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;People with migraine often use preventive and acute treatments concomitantly for breakthrough attacks. ZAV 10-mg nasal spray is the first intranasal, small-molecule CGRP receptor antagonist approved for the acute treatment of migraine with or without aura in adults.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This was a subgroup analysis of data from a multicenter, single-arm, open-label, phase 2/3 clinical trial that assessed the safety and tolerability of ZAV for the acute treatment of migraine. Participants self-administered 1 ZAV dose/day as needed up to 8 times/month for up to 52 weeks to treat migraine attacks of any severity. Participants were categorized into five cohorts based on their current or concomitant use of preventive treatments: ZAV + CGRP mAbs, ZAV + OSPs, ZAV + CGRP mAbs or OSPs, ZAV monotherapy (ZAVmono), and the overall study population. Adverse events (AEs), clinical laboratory results, and vital signs data were evaluated and summarized descriptively.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 603 participants self-administered ≥1 dose of ZAV and 341 participants (56.6%) completed the study. Among the 603 ZAV-treated participants, 39 (6.5%) received ZAV + CGRP mAbs, 72 (11.9%) received ZAV + OSPs, 103 (17.1%) received ZAV + CGRP mAbs or OSPs (eight participants received both CGRP mAbs and OSPs), and 500 (82.9%) received ZAVmono. Baseline characteristics were similar across cohorts. The mean number of ZAV doses self-administered per month was similar across cohorts (3.1-3.3). The proportion of participants experiencing an AE was similar across cohorts (range: 73.6-76.9%). The most frequent AEs were dysgeusia (range across cohorts: 28.2-41.7%), nasal discomfort (9.7-15.4%), COVID-19 (7.2-8.7%), nausea (4.2-10.3%), back pain (4.4-15.4%), throat irritation (4.4-12.8%), and nasal congestion (5.2-7.7%). Most AEs had mild-to-moderate severity and resolved without treatment. The proportion of participants who discontinued due to an AE was similar across cohorts (range: 4.2-7.7%). No serious AEs related to ZAV treatment occurred. The proportion of participants who experienced a local-irritation AE was similar across cohorts (range: 49.4-51.4%), as was the proportion who experienced a hepatic-related AE (3.8-7.7%). No AEs related to medication-overuse headache, suicidality, or cardiovascular events occurred. No clinically meaningful trends in laboratory test results or vital signs were observed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Self-administration of ZAV 10-mg nasal spray for the acute treatment of migraine up to 8 times/month for up to 52 weeks appeared well-tolerated irrespectiv","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101737","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
Cognition during ictal and interictal migraine phases: A pilot study using ecological momentary assessment. 偏头痛发作期和发作间期的认知:一项使用生态瞬时评估的试点研究。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14964
Laura Sebrow, Richard B Lipton, Christopher L Metts, Paul J Mattis, Jonathan M Feldman, Megan Lacritz, Elizabeth K Seng
{"title":"Cognition during ictal and interictal migraine phases: A pilot study using ecological momentary assessment.","authors":"Laura Sebrow, Richard B Lipton, Christopher L Metts, Paul J Mattis, Jonathan M Feldman, Megan Lacritz, Elizabeth K Seng","doi":"10.1111/head.14964","DOIUrl":"https://doi.org/10.1111/head.14964","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The present study aimed to evaluate cognitive functioning during ictal and interictal phases of the migraine attack using smart-phone based ambulatory cognitive tests.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Cognitive problems have been increasingly recognized as an important part of the burden of migraine. People with migraine report subjective cognitive problems more often during the ictal phase than during the interictal phase of the migraine attack. However, objective evidence of cognitive impairment during attacks is limited. To address this gap, we used smart-phones and an ecological momentary assessment (EMA) design to repeatedly assess migraine symptoms and cognitive performance as people went about their daily lives.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this longitudinal study, 19 adults with migraine completed an EMA protocol. Using a downloadable iPhone app, participants were asked five times daily to complete a headache questionnaire and to take an ultra-brief cognitive battery over 2-4 weeks. The cognitive battery (i.e., Trail Making Test [TMT], Stroop Test, Spatial Memory Test) assessed the domains of working memory, processing speed, and aspects of executive functioning (set-shifting, cognitive inhibition). The ictal phases were defined by the presence of current head pain. The interictal phases were defined by the absence of head pain. Separate mixed-effects models were run for each cognitive outcome to examine cognitive performance during the ictal phase relative to the interictal phase.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Participants were 68% female and 84% White; the median (interquartile range) age was 34.0 (27.0-39.0) years. The majority had a tertiary education with 47% holding an undergraduate degree and 47% a graduate degree. The Stroop Test and the Spatial Memory test revealed cognitive decrements in performance in the ictal phase relative to the interictal phase. Specifically, during the ictal phases, there were fewer Spatial Memory successes/sequences (B = -0.20, 95% confidence interval [CI] -0.38 to -0.01; p = 0.038) and Spatial Memory largest successes/sequences (B = -0.22, 95% CI -0.43 to -0.01; p = 0.038). Additionally, there were fewer Stroop non-congruent items correct (B = -0.37, 95% CI -0.70 to -0.03, p = 0.006; odds ratio 3.03, 95% CI 1.26-7.26, p = 0.013), and greater Stroop non-congruent item errors (B = 0.23, 95% CI 0.02-0.44; p = 0.031). The TMT parts A and B did not significantly differ based on migraine phase.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;We found decrements in objective cognitive performance in the domains of working memory and cognitive inhibition in the ictal vs. the interictal phases of migraine using EMA, replicating and extending prior work on cognitive performance. These methods further characterize the cognitive burden of migraine and could be extended to assess cognition in the prodrome and postdrome, as well as assess the cognitive benefits of acute and preventive trea","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109786","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
A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache. 一项多中心、前瞻性、单臂研究:60天外周神经刺激枕神经治疗头痛。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14948
Genaro G Gutierrez, Zachary L McCormick, Mitchell P Engle, Christopher A Gilmore, Matthew J Pingree, Jason E Pope, David J DiBenedetto, Narayan R Kissoon, Puneet K Sayal, Claire A Zurn, Nathan D Crosby, Joseph W Boggs
{"title":"A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache.","authors":"Genaro G Gutierrez, Zachary L McCormick, Mitchell P Engle, Christopher A Gilmore, Matthew J Pingree, Jason E Pope, David J DiBenedetto, Narayan R Kissoon, Puneet K Sayal, Claire A Zurn, Nathan D Crosby, Joseph W Boggs","doi":"10.1111/head.14948","DOIUrl":"https://doi.org/10.1111/head.14948","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study was to evaluate the efficacy and safety of a 60-day peripheral nerve stimulation (PNS) treatment targeting the occipital nerves for reducing pain and improving function in individuals diagnosed with cervicogenic headache or occipital neuralgia.</p><p><strong>Background: </strong>Headache conditions are prevalent and commonly disabling, and conventional therapeutic strategies are often insufficient. Development of a percutaneous 60-day PNS treatment has created new opportunities to evaluate PNS of the occipital nerves.</p><p><strong>Methods: </strong>This study was an institutional review board-approved, multicenter, prospective, single-arm study that enrolled participants from October 2022 to March 2024. Participants with cervicogenic headache or occipital neuralgia received a 60-day PNS treatment targeting the occipital nerves. The primary endpoint was the proportion reporting clinically significant (≥30%) reductions in average pain and/or pain interference at end of treatment (EOT). Additional analysis included the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference and additional outcomes including Patient Global Impression of Change, six-item Headache Impact Test, and Neck Disability Index.</p><p><strong>Results: </strong>At EOT, 90% of participants (18/20) met the primary endpoint. Further, 85% (17/20) and 83% (15/18) reported ≥50% reductions in pain and/or pain interference at EOT and 3 months, respectively. Clinically meaningful improvements were observed in functional and headache-related disability and quality-of-life measures. All study-related adverse events were non-serious.</p><p><strong>Conclusion: </strong>Most participants reported significant reductions in pain and/or pain interference following 60-day PNS targeting the occipital nerves. Outcomes through 3 months demonstrate how 60-day PNS offers an effective approach for the treatment of headache.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101735","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
Memantine as a migraine prophylactic agent in adolescents: A retrospective analysis. 美金刚作为预防青少年偏头痛的药物:回顾性分析。
IF 5.4 2区 医学
Headache Pub Date : 2025-05-20 DOI: 10.1111/head.14979
M Ismail K Yousaf, Francis D Hussey, Sara Pavitt, Samantha Irwin
{"title":"Memantine as a migraine prophylactic agent in adolescents: A retrospective analysis.","authors":"M Ismail K Yousaf, Francis D Hussey, Sara Pavitt, Samantha Irwin","doi":"10.1111/head.14979","DOIUrl":"https://doi.org/10.1111/head.14979","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109793","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
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