Lucia Jimena Zavala, Andreina Gil Ramirez, Kjersti Grøtta Vetvik, Rigmor Højland Jensen, Anders Hougaard
Objective: To assess the prevalence, frequency, and characteristics of headache disorders in transgender individuals receiving gender-affirming hormone therapy (GAHT), and to explore the relationship between GAHT and headache pathophysiology. We hypothesized that estrogen-based GAHT would be associated with increased risk of headache, particularly migraine, whereas testosterone-based GAHT would be associated with reduced headache burden.
Background: Migraine is a highly disabling headache disorder that disproportionately affects cisgender women, with hormonal fluctuations playing a key role in its pathophysiology. Despite extensive research in cisgender populations, there is a gap in our understanding about the prevalence and characteristics of headache disorders, including migraine, in transgender and nonbinary individuals undergoing GAHT, and there is true urgency to fill this knowledge gap.
Methods: We conducted a cross-sectional, observational study using an anonymous online survey targeting transgender and nonbinary individuals in Argentina from October 2023 to February 2024. Eligible participants were aged ≥18 years and receiving GAHT. The validated Migraine Screen Questionnaire (MS-Q) was used to identify migraine-like headaches. Additional items assessed changes in headache characteristics associated with GAHT.
Results: Of 160 participants, 102 (63.7%; 95% confidence interval [CI] 56.1%-70.8%) reported experiencing headaches. Of these, 86.3% (number [n] = 88) were receiving testosterone, 11.8% (n = 12) estrogens, and 2.0% (n = 2) were receiving other GAHT. Only 24.5% (n = 24) reported a prior headache diagnosis, including 18 participants (17.6%; 95% CI 11.3%-26.2%) with migraine. Based on the MS-Q, 46.1% (n = 47) screened positive for migraine-like headaches. New headache or worsening of headache was more frequently reported by estrogen users (66.6%) compared to those using testosterone (27.2%). Improvement or resolution of headaches was reported by 26.1% of testosterone users compared to 8.3% of estrogen users.
Conclusion: Estrogen-based GAHT was associated with a higher proportion of individuals reporting new or worsening headaches, whereas testosterone-based GAHT was more often associated with headache improvement. These associations underscore the need for further research into how GAHT modulates headache patterns, as well as the high rate of underdiagnosed headache disorders in this population.
{"title":"Headache in individuals undergoing hormone therapy for gender transition: A cross-sectional, observational study.","authors":"Lucia Jimena Zavala, Andreina Gil Ramirez, Kjersti Grøtta Vetvik, Rigmor Højland Jensen, Anders Hougaard","doi":"10.1111/head.15076","DOIUrl":"https://doi.org/10.1111/head.15076","url":null,"abstract":"<p><strong>Objective: </strong>To assess the prevalence, frequency, and characteristics of headache disorders in transgender individuals receiving gender-affirming hormone therapy (GAHT), and to explore the relationship between GAHT and headache pathophysiology. We hypothesized that estrogen-based GAHT would be associated with increased risk of headache, particularly migraine, whereas testosterone-based GAHT would be associated with reduced headache burden.</p><p><strong>Background: </strong>Migraine is a highly disabling headache disorder that disproportionately affects cisgender women, with hormonal fluctuations playing a key role in its pathophysiology. Despite extensive research in cisgender populations, there is a gap in our understanding about the prevalence and characteristics of headache disorders, including migraine, in transgender and nonbinary individuals undergoing GAHT, and there is true urgency to fill this knowledge gap.</p><p><strong>Methods: </strong>We conducted a cross-sectional, observational study using an anonymous online survey targeting transgender and nonbinary individuals in Argentina from October 2023 to February 2024. Eligible participants were aged ≥18 years and receiving GAHT. The validated Migraine Screen Questionnaire (MS-Q) was used to identify migraine-like headaches. Additional items assessed changes in headache characteristics associated with GAHT.</p><p><strong>Results: </strong>Of 160 participants, 102 (63.7%; 95% confidence interval [CI] 56.1%-70.8%) reported experiencing headaches. Of these, 86.3% (number [n] = 88) were receiving testosterone, 11.8% (n = 12) estrogens, and 2.0% (n = 2) were receiving other GAHT. Only 24.5% (n = 24) reported a prior headache diagnosis, including 18 participants (17.6%; 95% CI 11.3%-26.2%) with migraine. Based on the MS-Q, 46.1% (n = 47) screened positive for migraine-like headaches. New headache or worsening of headache was more frequently reported by estrogen users (66.6%) compared to those using testosterone (27.2%). Improvement or resolution of headaches was reported by 26.1% of testosterone users compared to 8.3% of estrogen users.</p><p><strong>Conclusion: </strong>Estrogen-based GAHT was associated with a higher proportion of individuals reporting new or worsening headaches, whereas testosterone-based GAHT was more often associated with headache improvement. These associations underscore the need for further research into how GAHT modulates headache patterns, as well as the high rate of underdiagnosed headache disorders in this population.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307770","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}
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
{"title":"Three years of remote electrical neuromodulation (REN) acute treatment for migraine shows consistent effectiveness and no tachyphylaxis phenomenon.","authors":"Stephanie J Nahas, Marius Birlea, Alit Stark-Inbar, Sharon Shmuely, Eden Mama, Alon Ironi, William B Young, Alan M Rapoport","doi":"10.1111/head.15069","DOIUrl":"https://doi.org/10.1111/head.15069","url":null,"abstract":"<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","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307791","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}
{"title":"Serum magnesium levels in children and adolescents with migraine: A prospective observational study.","authors":"Sharoon Qaiser, Kristine Shady","doi":"10.1111/head.15081","DOIUrl":"https://doi.org/10.1111/head.15081","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145307787","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}
Karissa N Arca, Allyson B Bazarsky, Derek Y Yuan, Raissa Villanueva, Deborah I Friedman, Andrew Charles
Objectives/background: This study was undertaken to review the published literature and provide a position statement from the American Headache Society regarding the safety, efficacy, and impact on access to care of telemedicine for the clinical management of patients with headache disorders. Access to specialized care in headache medicine is severely limited in the United States and worldwide. Telemedicine has been used as an approach to care delivery in headache medicine for more than a decade, with accelerated adoption during the COVID-19 pandemic. There is now uncertainty regarding the extent to which telemedicine will be accepted by health systems and reimbursed by payers moving forward. The purpose of this position statement is to summarize evidence and clinical experience supporting the utility of telemedicine in headache medicine.
Methods: Evidence regarding the safety and efficacy of telemedicine, and patient and clinician satisfaction with the use of telemedicine for headache specialty care, was gathered from a variety of sources, including PubMed, Google Scholar, and ClinicalTrials.gov. The results and conclusions based upon these results were reviewed and discussed by the authors and the Board of Directors of the American Headache Society to confirm consistency with clinical experience and to achieve consensus.
Results: Several randomized clinical trials and observational studies have been performed to compare telemedicine with in-person visits in the management of patients with headache disorders. These studies showed consistently that telemedicine is noninferior to in-person care based upon multiple outcome measures, including disability measures, patient satisfaction, and clinician satisfaction. In addition, these studies found that telemedicine rarely leads to a missed diagnosis of secondary headache or mismanagement of primary headache. Telemedicine has substantial advantages for patients, including improved access to care and reduced costs associated with obtaining care. Studies evaluating health care utilization indicate no significant differences between patients evaluated and treated virtually versus in person. Obvious limitations of telemedicine include the inability to perform an in-person physical exam or to perform injections. For a substantial number of patients, however, these limitations are outweighed by its advantages. The experience with telemedicine reported in the literature is consistent with the experience of the Board of Directors of the American Headache Society, who endorse its use for patients when feasible and appropriate.
Conclusion: Telemedicine has significantly advanced the care of patients with headache disorders. Its further development and deployment should be supported and reimbursed.
{"title":"Telemedicine is effective and safe for clinical management of patients with headache disorders: An American Headache Society position statement.","authors":"Karissa N Arca, Allyson B Bazarsky, Derek Y Yuan, Raissa Villanueva, Deborah I Friedman, Andrew Charles","doi":"10.1111/head.15084","DOIUrl":"https://doi.org/10.1111/head.15084","url":null,"abstract":"<p><strong>Objectives/background: </strong>This study was undertaken to review the published literature and provide a position statement from the American Headache Society regarding the safety, efficacy, and impact on access to care of telemedicine for the clinical management of patients with headache disorders. Access to specialized care in headache medicine is severely limited in the United States and worldwide. Telemedicine has been used as an approach to care delivery in headache medicine for more than a decade, with accelerated adoption during the COVID-19 pandemic. There is now uncertainty regarding the extent to which telemedicine will be accepted by health systems and reimbursed by payers moving forward. The purpose of this position statement is to summarize evidence and clinical experience supporting the utility of telemedicine in headache medicine.</p><p><strong>Methods: </strong>Evidence regarding the safety and efficacy of telemedicine, and patient and clinician satisfaction with the use of telemedicine for headache specialty care, was gathered from a variety of sources, including PubMed, Google Scholar, and ClinicalTrials.gov. The results and conclusions based upon these results were reviewed and discussed by the authors and the Board of Directors of the American Headache Society to confirm consistency with clinical experience and to achieve consensus.</p><p><strong>Results: </strong>Several randomized clinical trials and observational studies have been performed to compare telemedicine with in-person visits in the management of patients with headache disorders. These studies showed consistently that telemedicine is noninferior to in-person care based upon multiple outcome measures, including disability measures, patient satisfaction, and clinician satisfaction. In addition, these studies found that telemedicine rarely leads to a missed diagnosis of secondary headache or mismanagement of primary headache. Telemedicine has substantial advantages for patients, including improved access to care and reduced costs associated with obtaining care. Studies evaluating health care utilization indicate no significant differences between patients evaluated and treated virtually versus in person. Obvious limitations of telemedicine include the inability to perform an in-person physical exam or to perform injections. For a substantial number of patients, however, these limitations are outweighed by its advantages. The experience with telemedicine reported in the literature is consistent with the experience of the Board of Directors of the American Headache Society, who endorse its use for patients when feasible and appropriate.</p><p><strong>Conclusion: </strong>Telemedicine has significantly advanced the care of patients with headache disorders. Its further development and deployment should be supported and reimbursed.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145299723","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}
Olga Grodzka, Michał Borończyk, Anna Zduńska, Julia Węgrzynek-Gallina, Izabela Domitrz, Anetta Lasek-Bal
Objective: This review was conducted to analyze the current knowledge on the topic of the relation between migraine and patent foramen ovale (PFO) and indicate the most crucial clinical implications.
Background: Migraine is a primary headache disorder that affects a significant part of the global population. Importantly, it has been considered a risk factor for ischemic stroke, especially in women with migraine with aura. The foramen ovale is a physiological opening in the atrial septum formed during fetal life, which closes in most people in the first year after birth. However, in some people, it can be present in adulthood and is called the patent foramen ovale. PFO is more likely to occur in patients with migraine compared to the population not experiencing migraine headaches.
Methods: Two review teams, comprising migraine experts and stroke experts, were engaged in the screening process, resulting in the inclusion of 204 relevant publications. To be considered for inclusion, an article had to directly cover the topic of PFO or migraine.
Results: In the following work, we have focused on several aspects regarding the direct and indirect relationship between migraine and PFO. Although analyzing migraine pathogenesis, apart from the straight link between PFO and migraine, others are also considered, such as a prominent Eustachian valve or Chiari valve, causing a high-risk PFO or a paradoxical embolism. Regarding the clinical practice, the prevalence of PFO and migraine, indications for exact therapies, and subsequently, neuroimaging in the view of PFO and migraine, have been scrutinized. Another crucial aspect of this review is the risk of stroke in patients with migraine, considering the PFO presence. It is suggested that patients with migraine have more vascular lesions on magnetic resonance imaging and more often experience strokes. Thus, the question arises whether PFO should be closed as stroke prophylaxis in every migraine patient.
Conclusions: Several aspects have been explored; however, more research is needed to draw clear conclusions with further indications for clinical practice. Nevertheless, it seems that not in all patients with migraine with PFO should the closure procedure be performed, but when the PFO is of a high-risk form or there are other indications, it should at least be considered.
{"title":"Migraine and patent foramen ovale: correlation, coexistence, dependence. A narrative review.","authors":"Olga Grodzka, Michał Borończyk, Anna Zduńska, Julia Węgrzynek-Gallina, Izabela Domitrz, Anetta Lasek-Bal","doi":"10.1111/head.15067","DOIUrl":"https://doi.org/10.1111/head.15067","url":null,"abstract":"<p><strong>Objective: </strong>This review was conducted to analyze the current knowledge on the topic of the relation between migraine and patent foramen ovale (PFO) and indicate the most crucial clinical implications.</p><p><strong>Background: </strong>Migraine is a primary headache disorder that affects a significant part of the global population. Importantly, it has been considered a risk factor for ischemic stroke, especially in women with migraine with aura. The foramen ovale is a physiological opening in the atrial septum formed during fetal life, which closes in most people in the first year after birth. However, in some people, it can be present in adulthood and is called the patent foramen ovale. PFO is more likely to occur in patients with migraine compared to the population not experiencing migraine headaches.</p><p><strong>Methods: </strong>Two review teams, comprising migraine experts and stroke experts, were engaged in the screening process, resulting in the inclusion of 204 relevant publications. To be considered for inclusion, an article had to directly cover the topic of PFO or migraine.</p><p><strong>Results: </strong>In the following work, we have focused on several aspects regarding the direct and indirect relationship between migraine and PFO. Although analyzing migraine pathogenesis, apart from the straight link between PFO and migraine, others are also considered, such as a prominent Eustachian valve or Chiari valve, causing a high-risk PFO or a paradoxical embolism. Regarding the clinical practice, the prevalence of PFO and migraine, indications for exact therapies, and subsequently, neuroimaging in the view of PFO and migraine, have been scrutinized. Another crucial aspect of this review is the risk of stroke in patients with migraine, considering the PFO presence. It is suggested that patients with migraine have more vascular lesions on magnetic resonance imaging and more often experience strokes. Thus, the question arises whether PFO should be closed as stroke prophylaxis in every migraine patient.</p><p><strong>Conclusions: </strong>Several aspects have been explored; however, more research is needed to draw clear conclusions with further indications for clinical practice. Nevertheless, it seems that not in all patients with migraine with PFO should the closure procedure be performed, but when the PFO is of a high-risk form or there are other indications, it should at least be considered.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291952","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}
Simy K Parikh, Constance R Deline, Morgan McCreary, Farnaz Amoozegar, Tim J Amrhein, Ian R Carroll, Jeremy K Cutsforth-Gregory, Linda G Leithe, Peter G Kranz, Charles Louy, Marcel M Maya, Abhay Moghekar, Jill Rau, Stephen Silberstein, Wouter I Schievink, Deborah I Friedman
Objective: The objective of this study was to summarize the available evidence regarding the clinical value and trend over time of lumbar cerebrospinal fluid (CSF) opening pressure utilization to diagnose spontaneous intracranial hypotension (SIH).
Background: CSF opening pressure obtained via lumbar puncture is one of the diagnostic criteria for SIH based on the International Criteria for Headache Disorders, 3rd Edition (ICHD-3), but it has questionable utility as an initial investigation for diagnosing SIH.
Methods: The authors performed a systematic literature review and meta-analysis. PubMed/MEDLINE, Scopus, and Cochrane Library were searched from inception to October 2022. Original studies and case series in English reporting three or more patients with suspected or known SIH and CSF pressure measurement were included. Meta-analyses and meta-regression were used to calculate pooled estimates and examine the impact of age, sex, and publication year on outcomes, including CSF pressure < 60 mm CSF, orthostatic headache, and positive findings on brain magnetic resonance imaging (MRI), spinal imaging, and radionuclide studies.
Results: For every 1-year increase in the year of publication, the odds of reporting low CSF pressure decreased by 6.20% (adjusted odds ratio [aOR] = 0.94, aOR 95% confidence interval [CI] = [0.90, 0.97], p = 0.001), the odds of reporting a positive brain MRI increased by 4.67% (aOR = 1.05, aOR 95% CI = [1.01, 1.09], p = 0.026), and the odds of reporting orthostatic headache increased by 9.13% (aOR = 1.09, aOR 95% CI = [1.03, 1.15], p = 0.002). Each 1% increase in the percentage of patients with orthostatic headache was associated with a 3.13% increase in the odds of low CSF pressure (aOR = 1.03, aOR 95% CI = [1.01, 1.05], p = 0.003). Similarly, as the percentage of patients with low CSF pressure increased by 1%, there was a 2.53% increase in the odds of orthostatic headache (aOR = 1.03, aOR 95% CI = [1.01, 1.04], p = 0.005). It was estimated that 31.9% of patients with SIH had normal opening pressure (95% CI = [24.0%, 40.8%], prediction interval = [5.0%, 80.5%]). Every 1% increase in the percentage of patients with positive brain MRI was associated with a 5.25% increase in the odds of positive spinal imaging (aOR = 1.05, aOR 95% CI = [1.00, 1.11], p = 0.047). Age and positive radionuclide study did not significantly impact the outcomes measured. The corresponding I2 for each outcome was reduced by controlling for study-wide covariates believed to impact the prevalence of each outcome. Sensitivity analyses did not reveal discrepancies in results when studies requiring outcomes of interest were removed.
Conclusion: Our analysis found that recent studies indicate a reduced reliance on opening pressure for diagnosing SIH. Rather, results suggest an increasing reliance on contrast-enhanced brain MRI, spine
目的:本研究的目的是总结有关腰椎脑脊液(CSF)开口压力利用诊断自发性颅内低血压(SIH)的临床价值和趋势的现有证据。背景:根据国际头痛疾病标准第三版(ICHD-3),经腰椎穿刺获得的脑脊液开口压力是SIH的诊断标准之一,但它作为诊断SIH的初步调查的实用性值得怀疑。方法:作者进行了系统的文献综述和荟萃分析。PubMed/MEDLINE、Scopus和Cochrane图书馆从成立到2022年10月进行了检索。纳入了3例或更多疑似或已知SIH患者和CSF压力测量的英文原始研究和病例系列。meta分析和meta回归用于计算汇总估计值,并检查年龄、性别和出版年份对结果的影响,包括脑脊液压力。出版的今年每增加1年,报告脑脊液压力低的几率下降了6.20%(调整优势比(aOR) = 0.94, aOR 95%可信区间[CI] = [0.90, 0.97], p = 0.001),报告一个积极的大脑核磁共振的几率增加了4.67%(优势比= 1.05,aOR 95% CI = [1.01, 1.09], p = 0.026),和报告直立性头痛的几率增加了9.13%(优势比= 1.09,aOR 95% CI = [1.03, 1.15], p = 0.002)。直立性头痛患者比例每增加1%,脑脊液低压的几率增加3.13% (aOR = 1.03, aOR 95% CI = [1.01, 1.05], p = 0.003)。同样,脑脊液低压患者的比例每增加1%,直立性头痛的几率增加2.53% (aOR = 1.03, aOR 95% CI = [1.01, 1.04], p = 0.005)。估计31.9%的SIH患者有正常的开孔压力(95% CI =[24.0%, 40.8%],预测区间=[5.0%,80.5%])。脑MRI阳性患者比例每增加1%,脊柱成像阳性的几率增加5.25% (aOR = 1.05, aOR 95% CI = [1.00, 1.11], p = 0.047)。年龄和放射性核素阳性研究对测量结果没有显著影响。通过控制研究范围内被认为影响每种结果患病率的协变量,降低了每种结果的相应I2。敏感性分析并没有显示出需要相关结果的研究在结果上的差异。结论:我们的分析发现,最近的研究表明,在诊断SIH时对开口压力的依赖程度有所降低。相反,结果表明越来越依赖于增强脑MRI,脊柱成像和SIH诊断的临床特征。
{"title":"The contribution of lumbar puncture opening pressure in the diagnosis of spontaneous intracranial hypotension: A systematic literature review and meta-analysis.","authors":"Simy K Parikh, Constance R Deline, Morgan McCreary, Farnaz Amoozegar, Tim J Amrhein, Ian R Carroll, Jeremy K Cutsforth-Gregory, Linda G Leithe, Peter G Kranz, Charles Louy, Marcel M Maya, Abhay Moghekar, Jill Rau, Stephen Silberstein, Wouter I Schievink, Deborah I Friedman","doi":"10.1111/head.15060","DOIUrl":"https://doi.org/10.1111/head.15060","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to summarize the available evidence regarding the clinical value and trend over time of lumbar cerebrospinal fluid (CSF) opening pressure utilization to diagnose spontaneous intracranial hypotension (SIH).</p><p><strong>Background: </strong>CSF opening pressure obtained via lumbar puncture is one of the diagnostic criteria for SIH based on the International Criteria for Headache Disorders, 3rd Edition (ICHD-3), but it has questionable utility as an initial investigation for diagnosing SIH.</p><p><strong>Methods: </strong>The authors performed a systematic literature review and meta-analysis. PubMed/MEDLINE, Scopus, and Cochrane Library were searched from inception to October 2022. Original studies and case series in English reporting three or more patients with suspected or known SIH and CSF pressure measurement were included. Meta-analyses and meta-regression were used to calculate pooled estimates and examine the impact of age, sex, and publication year on outcomes, including CSF pressure < 60 mm CSF, orthostatic headache, and positive findings on brain magnetic resonance imaging (MRI), spinal imaging, and radionuclide studies.</p><p><strong>Results: </strong>For every 1-year increase in the year of publication, the odds of reporting low CSF pressure decreased by 6.20% (adjusted odds ratio [aOR] = 0.94, aOR 95% confidence interval [CI] = [0.90, 0.97], p = 0.001), the odds of reporting a positive brain MRI increased by 4.67% (aOR = 1.05, aOR 95% CI = [1.01, 1.09], p = 0.026), and the odds of reporting orthostatic headache increased by 9.13% (aOR = 1.09, aOR 95% CI = [1.03, 1.15], p = 0.002). Each 1% increase in the percentage of patients with orthostatic headache was associated with a 3.13% increase in the odds of low CSF pressure (aOR = 1.03, aOR 95% CI = [1.01, 1.05], p = 0.003). Similarly, as the percentage of patients with low CSF pressure increased by 1%, there was a 2.53% increase in the odds of orthostatic headache (aOR = 1.03, aOR 95% CI = [1.01, 1.04], p = 0.005). It was estimated that 31.9% of patients with SIH had normal opening pressure (95% CI = [24.0%, 40.8%], prediction interval = [5.0%, 80.5%]). Every 1% increase in the percentage of patients with positive brain MRI was associated with a 5.25% increase in the odds of positive spinal imaging (aOR = 1.05, aOR 95% CI = [1.00, 1.11], p = 0.047). Age and positive radionuclide study did not significantly impact the outcomes measured. The corresponding I<sup>2</sup> for each outcome was reduced by controlling for study-wide covariates believed to impact the prevalence of each outcome. Sensitivity analyses did not reveal discrepancies in results when studies requiring outcomes of interest were removed.</p><p><strong>Conclusion: </strong>Our analysis found that recent studies indicate a reduced reliance on opening pressure for diagnosing SIH. Rather, results suggest an increasing reliance on contrast-enhanced brain MRI, spine ","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145291920","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}
Daniel C Ogrezeanu, Rodrigo Núñez-Cortés, Joaquín Salazar-Méndez, Iván Cuyul-Vásquez, Rubén López-Bueno, Francisco José Ferrer-Sargues, Lars Louis Andersen, Joaquín Calatayud, Luis Suso-Martí
Background: Evidence suggests that exercise has clinically relevant benefits for migraine, but an optimal prescription standard remains undefined. We aimed to assess the effectiveness of aerobic exercise on migraine intensity and frequency through a dose-response meta-analysis.
Methods: A data search was performed in PubMed, PEDro, Google Scholar, and EBSCO from inception to September 1, 2024. Randomized controlled trials and quasi-experimental studies of aerobic exercise in patients with a clinical diagnosis of migraine were included. The outcome measures were pain intensity and migraine frequency. The dose-response relationship was evaluated using a dose-response meta-analysis.
Results: Fifteen studies (253 participants) were included. Meta-analysis showed a statistically significant decrease in pain intensity between pre and post intervention (standardized mean differences [SMD], -1.1; 95% confidence interval [CI], -1.72 to -0.47). The spline model showed a U-shape statistically significant association (χ2 = 112.03, df = 2, p < 0.001) between total minutes of aerobic exercise and reduction in pain intensity. A minimum dose of 200 min was required for moderate effects, with a maximum effect at 900 min (SMD, -2.4; 95% CI, -2.85 to -1.95). Meta-analysis showed a statistically significant decrease in migraine frequency between pre and post intervention (SMD, -0.79; 95% CI, -1.1 to -0.47). The spline model showed a U-shape statistically significant association (χ2 = 86.41, dl = 2, p < 0.001) between total minutes of aerobic exercise and reduction in migraine frequency. A minimum dose of 300 total minutes of aerobic exercise program duration was required to obtain a moderate effect in reducing migraine frequency, with a maximum effect at 950 min (SMD, -1.55; 95% CI, -1.87 to -1.22).
Conclusions: This meta-analysis suggests that aerobic exercise may be effective in reducing both pain intensity and migraine frequency in people with migraine. The greatest observed effect on both variables was observed at a cumulative dose of approximately 900-950 total minutes of aerobic exercise during the program, and higher doses may not present additional benefits. These findings support a preliminary recommendation of 3 weekly 30-min sessions over 10-11 weeks, to be confirmed in future high-quality trials.
{"title":"How much aerobic exercise is needed to reduce migraine? A dose-response meta-analysis of pain intensity and frequency.","authors":"Daniel C Ogrezeanu, Rodrigo Núñez-Cortés, Joaquín Salazar-Méndez, Iván Cuyul-Vásquez, Rubén López-Bueno, Francisco José Ferrer-Sargues, Lars Louis Andersen, Joaquín Calatayud, Luis Suso-Martí","doi":"10.1111/head.15070","DOIUrl":"https://doi.org/10.1111/head.15070","url":null,"abstract":"<p><strong>Background: </strong>Evidence suggests that exercise has clinically relevant benefits for migraine, but an optimal prescription standard remains undefined. We aimed to assess the effectiveness of aerobic exercise on migraine intensity and frequency through a dose-response meta-analysis.</p><p><strong>Methods: </strong>A data search was performed in PubMed, PEDro, Google Scholar, and EBSCO from inception to September 1, 2024. Randomized controlled trials and quasi-experimental studies of aerobic exercise in patients with a clinical diagnosis of migraine were included. The outcome measures were pain intensity and migraine frequency. The dose-response relationship was evaluated using a dose-response meta-analysis.</p><p><strong>Results: </strong>Fifteen studies (253 participants) were included. Meta-analysis showed a statistically significant decrease in pain intensity between pre and post intervention (standardized mean differences [SMD], -1.1; 95% confidence interval [CI], -1.72 to -0.47). The spline model showed a U-shape statistically significant association (χ<sup>2</sup> = 112.03, df = 2, p < 0.001) between total minutes of aerobic exercise and reduction in pain intensity. A minimum dose of 200 min was required for moderate effects, with a maximum effect at 900 min (SMD, -2.4; 95% CI, -2.85 to -1.95). Meta-analysis showed a statistically significant decrease in migraine frequency between pre and post intervention (SMD, -0.79; 95% CI, -1.1 to -0.47). The spline model showed a U-shape statistically significant association (χ<sup>2</sup> = 86.41, dl = 2, p < 0.001) between total minutes of aerobic exercise and reduction in migraine frequency. A minimum dose of 300 total minutes of aerobic exercise program duration was required to obtain a moderate effect in reducing migraine frequency, with a maximum effect at 950 min (SMD, -1.55; 95% CI, -1.87 to -1.22).</p><p><strong>Conclusions: </strong>This meta-analysis suggests that aerobic exercise may be effective in reducing both pain intensity and migraine frequency in people with migraine. The greatest observed effect on both variables was observed at a cumulative dose of approximately 900-950 total minutes of aerobic exercise during the program, and higher doses may not present additional benefits. These findings support a preliminary recommendation of 3 weekly 30-min sessions over 10-11 weeks, to be confirmed in future high-quality trials.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286098","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}
Gabriel Paiva da Silva Lima, Renata Rao, Gyöngyi Szabó, Sebastian Szklener, Cristina Tassorelli, Marcin Nastaj, Denise E Chou, Ani C Khodavirdi, Mahan Chehrenama, Yineng Zhu, Ajay K Bhatia, David W Dodick
Objective: To evaluate the effect of erenumab treatment beyond monthly migraine days in patients with high-frequency episodic migraine who did not respond to at least one previous migraine preventive treatment.
Background: Reduction in monthly migraine days has been the efficacy standard for migraine preventive treatments; however, it does not fully capture the holistic benefit of the therapy. Erenumab, a monoclonal antibody targeting the calcitonin gene-related peptide pathway, has demonstrated reduction in monthly migraine days and improvement in function in patients with episodic and chronic migraine.
Methods: In this phase 4, interventional, double-blind, randomized, placebo-controlled, multicenter, global study, treatment with erenumab was assessed over 4 months in adults with high-frequency episodic migraine. The study was conducted at 61 sites located across North America and Europe between September 2020 and October 2023. Patients with ≥1 qualifying oral triptan-treated migraine attack at baseline were randomized to receive erenumab 140 mg or placebo subcutaneously once monthly. The primary endpoint was change from baseline in mean monthly hours of at least moderate headache pain intensity over months 1, 2, and 3; secondary endpoints included change from baseline in mean monthly function, mean monthly duration of at least moderate pain intensity in migraine attacks, and mean monthly peak migraine pain intensity. Safety outcomes were also assessed.
Results: Of 512 randomized patients, 510 received erenumab 140 mg (n = 254) or placebo (n = 256) once monthly. Demographics and baseline characteristics were balanced between the two treatment arms. Erenumab 140 mg was superior to placebo in reducing duration of moderate or severe headache pain intensity over months 1, 2, and 3 (least squares mean [95% confidence interval {CI}] difference, -7.95 [-11.45, -4.46]; p < 0.001). Compared with placebo, erenumab significantly reduced migraine functional impact as assessed by the four domains of the Migraine Functional Impact Questionnaire, with a least squares mean (95% CI) difference of -7.36 (-10.80, -3.92) for physical functioning, -7.10 (-10.34, -3.87) for usual activities, -6.82 (-10.37, -3.27) for social functioning, and - 7.05 (-10.76, -3.34) for emotional functioning (p < 0.001 for all domains). Significant reductions with erenumab compared with placebo were also observed in duration of at least moderate pain intensity in residual or break-through migraine attacks (least squares mean [95% CI] difference, -1.07 [-1.92, -0.22]; p = 0.013) and peak migraine pain intensity (-0.48 [-0.85, -0.11]; p = 0.011). Incidence of grade 3 adverse events was 1.6% with erenumab and 1.2% with placebo; no grade 4 or fatal adverse events were reported in either treatment arm.
Conclusion: Findings from the EMBRACE study demonstrated that treatment with er
{"title":"Comprehensive assessment of erenumab efficacy in participants with high-frequency episodic migraine with at least one previously failed preventive treatment: The EMBRACE study.","authors":"Gabriel Paiva da Silva Lima, Renata Rao, Gyöngyi Szabó, Sebastian Szklener, Cristina Tassorelli, Marcin Nastaj, Denise E Chou, Ani C Khodavirdi, Mahan Chehrenama, Yineng Zhu, Ajay K Bhatia, David W Dodick","doi":"10.1111/head.15071","DOIUrl":"https://doi.org/10.1111/head.15071","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the effect of erenumab treatment beyond monthly migraine days in patients with high-frequency episodic migraine who did not respond to at least one previous migraine preventive treatment.</p><p><strong>Background: </strong>Reduction in monthly migraine days has been the efficacy standard for migraine preventive treatments; however, it does not fully capture the holistic benefit of the therapy. Erenumab, a monoclonal antibody targeting the calcitonin gene-related peptide pathway, has demonstrated reduction in monthly migraine days and improvement in function in patients with episodic and chronic migraine.</p><p><strong>Methods: </strong>In this phase 4, interventional, double-blind, randomized, placebo-controlled, multicenter, global study, treatment with erenumab was assessed over 4 months in adults with high-frequency episodic migraine. The study was conducted at 61 sites located across North America and Europe between September 2020 and October 2023. Patients with ≥1 qualifying oral triptan-treated migraine attack at baseline were randomized to receive erenumab 140 mg or placebo subcutaneously once monthly. The primary endpoint was change from baseline in mean monthly hours of at least moderate headache pain intensity over months 1, 2, and 3; secondary endpoints included change from baseline in mean monthly function, mean monthly duration of at least moderate pain intensity in migraine attacks, and mean monthly peak migraine pain intensity. Safety outcomes were also assessed.</p><p><strong>Results: </strong>Of 512 randomized patients, 510 received erenumab 140 mg (n = 254) or placebo (n = 256) once monthly. Demographics and baseline characteristics were balanced between the two treatment arms. Erenumab 140 mg was superior to placebo in reducing duration of moderate or severe headache pain intensity over months 1, 2, and 3 (least squares mean [95% confidence interval {CI}] difference, -7.95 [-11.45, -4.46]; p < 0.001). Compared with placebo, erenumab significantly reduced migraine functional impact as assessed by the four domains of the Migraine Functional Impact Questionnaire, with a least squares mean (95% CI) difference of -7.36 (-10.80, -3.92) for physical functioning, -7.10 (-10.34, -3.87) for usual activities, -6.82 (-10.37, -3.27) for social functioning, and - 7.05 (-10.76, -3.34) for emotional functioning (p < 0.001 for all domains). Significant reductions with erenumab compared with placebo were also observed in duration of at least moderate pain intensity in residual or break-through migraine attacks (least squares mean [95% CI] difference, -1.07 [-1.92, -0.22]; p = 0.013) and peak migraine pain intensity (-0.48 [-0.85, -0.11]; p = 0.011). Incidence of grade 3 adverse events was 1.6% with erenumab and 1.2% with placebo; no grade 4 or fatal adverse events were reported in either treatment arm.</p><p><strong>Conclusion: </strong>Findings from the EMBRACE study demonstrated that treatment with er","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286049","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}
Julia Peris-Subiza, Víctor Obach, Daniel Guisado-Alonso, Fernando Velasco Juanes, Rocío Álvarez Escudero, María Martín Bujanda, Sonsoles Aranceta, Aintzine Ruisánchez, Natalia Roncero, Ane Mínguez-Olaondo, Amaya Echeverria, Alba López-Bravo, Ángel Luis Guerrero-Peral, David García-Azorín, Elisa Cuadrado-Godia
Background: Patients with migraine aged ≥65 years old are underrepresented in clinical trials. This study compares effectiveness, excellent response, and tolerability of galcanezumab in patients ≥65 years and those younger than 65 years, specifically assessing age as a predictor of response.
Methods: This real-life, multicenter cohort study included patients with chronic or high-frequency episodic migraine who did not respond to more than or equal to three preventive drugs, treated with galcanezumab, and followed for 12 months from 12 Spanish hospitals, between November 2019 and January 2022. Effectiveness was defined as ≥50% reduction in monthly headache days (MHD), and excellent response as ≥75% reduction at 6 months. Tolerability was based on the percentage of patients discontinuing due to adverse events.
Results: We included 1055 patients (934 patients <65 years, 121 patients ≥65 years). Older patients had higher baseline MHD [25 (interquartile range [IQR] 15-30) vs. 20 (14-30), p = 0.045], but lower HIT-6 scores [67 (IQR 63-72) vs. 69 (66-73), p < 0.001]. Effectiveness was similar across age groups at 3 (57.0% vs. 48.8%, p = 0.090), 6 (57.0% vs. 51.8%, p = 0.281), and 12 months (52.1% vs. 51.4%, p = 0.889). However, excellent response was more frequent in the ≥65 years group at 3 months (32.2% vs. 23.1%, p = 0.028) and 6 months (33.9% vs. 23.5%, p = 0.012), with a non-significant difference at 12 months (33.1% vs. 25.4%, p = 0.071). Tolerability was comparable within age groups (5.8% discontinuation due to adverse effects in patients ≥65 years vs. 6.7% in patients <65 years; p = 0.837). Age was independently associated with effectiveness (adjusted odds ratio [aOR]: 1.02; 95% confidence interval [CI]: 1.004-1.03) and excellent response (aOR: 1.02; 95% CI: 1.01-1.04). A statistically significant association was found in the logistic regression model for excellent response when age was dichotomized at 65 years, with increasing age linked to a higher likelihood of an excellent treatment response (aOR: 1.79; 95% CI: 1.13-2.82, p = 0.012).
Conclusions: Galcanezumab is as effective and well-tolerated in patients aged ≥65 years as in younger patients but older patients showed a higher rate of excellent response. Age is associated with a better response to galcanezumab.
{"title":"Effectiveness and tolerability of galcanezumab for migraine prevention in patients ≥65 years: A real-life multicenter study.","authors":"Julia Peris-Subiza, Víctor Obach, Daniel Guisado-Alonso, Fernando Velasco Juanes, Rocío Álvarez Escudero, María Martín Bujanda, Sonsoles Aranceta, Aintzine Ruisánchez, Natalia Roncero, Ane Mínguez-Olaondo, Amaya Echeverria, Alba López-Bravo, Ángel Luis Guerrero-Peral, David García-Azorín, Elisa Cuadrado-Godia","doi":"10.1111/head.15064","DOIUrl":"https://doi.org/10.1111/head.15064","url":null,"abstract":"<p><strong>Background: </strong>Patients with migraine aged ≥65 years old are underrepresented in clinical trials. This study compares effectiveness, excellent response, and tolerability of galcanezumab in patients ≥65 years and those younger than 65 years, specifically assessing age as a predictor of response.</p><p><strong>Methods: </strong>This real-life, multicenter cohort study included patients with chronic or high-frequency episodic migraine who did not respond to more than or equal to three preventive drugs, treated with galcanezumab, and followed for 12 months from 12 Spanish hospitals, between November 2019 and January 2022. Effectiveness was defined as ≥50% reduction in monthly headache days (MHD), and excellent response as ≥75% reduction at 6 months. Tolerability was based on the percentage of patients discontinuing due to adverse events.</p><p><strong>Results: </strong>We included 1055 patients (934 patients <65 years, 121 patients ≥65 years). Older patients had higher baseline MHD [25 (interquartile range [IQR] 15-30) vs. 20 (14-30), p = 0.045], but lower HIT-6 scores [67 (IQR 63-72) vs. 69 (66-73), p < 0.001]. Effectiveness was similar across age groups at 3 (57.0% vs. 48.8%, p = 0.090), 6 (57.0% vs. 51.8%, p = 0.281), and 12 months (52.1% vs. 51.4%, p = 0.889). However, excellent response was more frequent in the ≥65 years group at 3 months (32.2% vs. 23.1%, p = 0.028) and 6 months (33.9% vs. 23.5%, p = 0.012), with a non-significant difference at 12 months (33.1% vs. 25.4%, p = 0.071). Tolerability was comparable within age groups (5.8% discontinuation due to adverse effects in patients ≥65 years vs. 6.7% in patients <65 years; p = 0.837). Age was independently associated with effectiveness (adjusted odds ratio [aOR]: 1.02; 95% confidence interval [CI]: 1.004-1.03) and excellent response (aOR: 1.02; 95% CI: 1.01-1.04). A statistically significant association was found in the logistic regression model for excellent response when age was dichotomized at 65 years, with increasing age linked to a higher likelihood of an excellent treatment response (aOR: 1.79; 95% CI: 1.13-2.82, p = 0.012).</p><p><strong>Conclusions: </strong>Galcanezumab is as effective and well-tolerated in patients aged ≥65 years as in younger patients but older patients showed a higher rate of excellent response. Age is associated with a better response to galcanezumab.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145286101","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}
Rebecca Erwin Wells, Junelyn Floyd, Hannah O'Brien, Nicole Tamol, Caroline Oliver, Camden Nelson, Joshua Phillips, Paige M Estave, Shivani Vaidya, Brian Moore, Katherine Hamilton, Ellie Adam, Nathaniel O'Connell, Justin B Moore, Richard B Lipton, Timothy T Houle, Zev Schuman-Olivier, Paula Gardiner, Scott W Powers
<p><strong>Objective: </strong>Our objective was to develop and assess the effectiveness of a national network of clinicians referring adults with migraine for a remotely delivered clinical trial.</p><p><strong>Background: </strong>A national practice-based research network in Headache Medicine would facilitate referrals into clinical trials. Given our unique, entirely virtual study, we established a national network of health care professionals to identify potential participants.</p><p><strong>Methods: </strong>The BE WELL with Migraine Champion Providers Network™ began to support clinician referrals across the United States into a remotely conducted clinical trial evaluating the efficacy of a nondrug virtual group intervention. Participant trial recruitment includes community outreach and clinician referrals, then potential participants complete a multi-step eligibility process. The primary study team obtains informed consent and collects all study outcomes. Clinicians interested in referring patients register for the Network via a Research Electronic Data Capture survey. The ongoing clinical trial allows for recruitment of trial participants and network members through 2026. We analyzed Network survey results through February 25, 2025, with descriptive statistics and qualitative analyses. We compared participant progression through eligibility assessment between clinician referral and community outreach.</p><p><strong>Results: </strong>The BE WELL with Migraine Champion Providers Network™ includes 46 clinicians across the United States through February 2025, and most (89%) of them are headache specialists. Although many have previously served as trial principal investigator (PI) (54%) or recruited (72%) for a trial in the past, 28% are recruiting for a clinical trial for the first time. Top motivating factors for Network participation included nonpharmacological option (n = 12), research contribution (n = 11), potential for patient improvement (n = 11), and working with PI (n = 9). To date, 905 participants completed the initial online screener, with 5% (n = 41) from clinician referrals and 95% (n = 864) from community recruitment. Of those, 12.3% (n = 107) were eligible to continue and consented and completed the virtual interview. After the interview, 65 participants progressed to the headache log run-in period and then were randomized/eligible for randomization (six from referrals, 59 from community). Of the original participants from clinician referrals who completed the online screener, 14.6% (six of 41) were randomized/eligible for randomization, compared to 6.8% (59 of 864) recruited via community. Once consented, 100% (six of six) of Network-referred patients progressed to randomization/eligibility for randomization versus only 58% (59 of 101) from community recruitment.</p><p><strong>Conclusion: </strong>The BE WELL with Migraine Champion Providers Network™ models the development and implementation of a national clinician referring ne
目的:我们的目的是开发和评估一个国家临床医生网络的有效性转介成人偏头痛进行远程交付临床试验。背景:在头痛医学的国家实践为基础的研究网络将促进转介到临床试验。鉴于我们独特的、完全虚拟的研究,我们建立了一个全国性的卫生保健专业人员网络,以确定潜在的参与者。方法:BE WELL with偏头痛冠军提供者网络™开始支持美国各地的临床医生转介到远程进行的临床试验,评估非药物虚拟组干预的疗效。参与者试验招募包括社区外展和临床医生推荐,然后潜在的参与者完成一个多步骤的资格流程。主要研究小组获得知情同意并收集所有研究结果。对转诊患者感兴趣的临床医生通过研究电子数据采集调查注册该网络。正在进行的临床试验允许招募试验参与者和网络成员到2026年。我们通过描述性统计和定性分析分析了截至2025年2月25日的网络调查结果。我们通过临床医生转诊和社区外展的资格评估来比较参与者的进展。结果:截至2025年2月,BE WELL with偏头痛冠军供应商网络™包括美国46名临床医生,其中大多数(89%)是头痛专家。虽然许多人以前曾担任过试验首席研究员(PI)(54%)或在过去的试验中招募(72%),但28%的人是首次为临床试验招募。网络参与的主要激励因素包括非药物选择(n = 12)、研究贡献(n = 11)、患者改善的潜力(n = 11)和与PI合作(n = 9)。到目前为止,905名参与者完成了最初的在线筛查,其中5% (n = 41)来自临床医生推荐,95% (n = 864)来自社区招募。其中,12.3% (n = 107)有资格继续并同意并完成虚拟访谈。访谈结束后,65名参与者进入头痛日志磨合期,然后随机化/符合随机化条件(6名来自转诊,59名来自社区)。在完成在线筛查的临床医生推荐的原始参与者中,14.6%(41人中的6人)被随机化/符合随机化条件,而通过社区招募的参与者为6.8%(864人中的59人)。一旦同意,100%(6 / 6)的网络转介患者进展到随机化/有资格随机化,而社区招募患者只有58%(101 / 59)。结论:BE WELL with偏头痛冠军提供者网络™模拟了国家临床医生转诊网络的发展和实施,可以帮助完成该领域的研究重点。虽然全国网络的发展和实施需要时间,但我们的结果表明,符合随机化条件的适当转诊的产量是社区招募的两倍多。
{"title":"Building a national headache medicine research network: The BE WELL with Migraine Champion Providers Network™.","authors":"Rebecca Erwin Wells, Junelyn Floyd, Hannah O'Brien, Nicole Tamol, Caroline Oliver, Camden Nelson, Joshua Phillips, Paige M Estave, Shivani Vaidya, Brian Moore, Katherine Hamilton, Ellie Adam, Nathaniel O'Connell, Justin B Moore, Richard B Lipton, Timothy T Houle, Zev Schuman-Olivier, Paula Gardiner, Scott W Powers","doi":"10.1111/head.15065","DOIUrl":"10.1111/head.15065","url":null,"abstract":"<p><strong>Objective: </strong>Our objective was to develop and assess the effectiveness of a national network of clinicians referring adults with migraine for a remotely delivered clinical trial.</p><p><strong>Background: </strong>A national practice-based research network in Headache Medicine would facilitate referrals into clinical trials. Given our unique, entirely virtual study, we established a national network of health care professionals to identify potential participants.</p><p><strong>Methods: </strong>The BE WELL with Migraine Champion Providers Network™ began to support clinician referrals across the United States into a remotely conducted clinical trial evaluating the efficacy of a nondrug virtual group intervention. Participant trial recruitment includes community outreach and clinician referrals, then potential participants complete a multi-step eligibility process. The primary study team obtains informed consent and collects all study outcomes. Clinicians interested in referring patients register for the Network via a Research Electronic Data Capture survey. The ongoing clinical trial allows for recruitment of trial participants and network members through 2026. We analyzed Network survey results through February 25, 2025, with descriptive statistics and qualitative analyses. We compared participant progression through eligibility assessment between clinician referral and community outreach.</p><p><strong>Results: </strong>The BE WELL with Migraine Champion Providers Network™ includes 46 clinicians across the United States through February 2025, and most (89%) of them are headache specialists. Although many have previously served as trial principal investigator (PI) (54%) or recruited (72%) for a trial in the past, 28% are recruiting for a clinical trial for the first time. Top motivating factors for Network participation included nonpharmacological option (n = 12), research contribution (n = 11), potential for patient improvement (n = 11), and working with PI (n = 9). To date, 905 participants completed the initial online screener, with 5% (n = 41) from clinician referrals and 95% (n = 864) from community recruitment. Of those, 12.3% (n = 107) were eligible to continue and consented and completed the virtual interview. After the interview, 65 participants progressed to the headache log run-in period and then were randomized/eligible for randomization (six from referrals, 59 from community). Of the original participants from clinician referrals who completed the online screener, 14.6% (six of 41) were randomized/eligible for randomization, compared to 6.8% (59 of 864) recruited via community. Once consented, 100% (six of six) of Network-referred patients progressed to randomization/eligibility for randomization versus only 58% (59 of 101) from community recruitment.</p><p><strong>Conclusion: </strong>The BE WELL with Migraine Champion Providers Network™ models the development and implementation of a national clinician referring ne","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12766894/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}