HeadachePub Date : 2024-10-19DOI: 10.1111/head.14844
Ali Reza Tavasoli, Reena G Rastogi, Eric V Hastriter
{"title":"Rising migraine incidence in adolescents despite stable prevalence in the US: A call for further investigation.","authors":"Ali Reza Tavasoli, Reena G Rastogi, Eric V Hastriter","doi":"10.1111/head.14844","DOIUrl":"https://doi.org/10.1111/head.14844","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463322","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}
HeadachePub Date : 2024-10-14DOI: 10.1111/head.14857
Elizabeth K Seng, Jacob Hill, Annie Kate Reeder, Pallavi Visvanathan, Rebecca E Wells, Richard B Lipton, Mia Minen, Amanda J Shallcross
{"title":"Feasibility, acceptability, and fidelity of remote-delivered abbreviated mindfulness-based cognitive therapy interventions for patients with migraine and depressive symptoms.","authors":"Elizabeth K Seng, Jacob Hill, Annie Kate Reeder, Pallavi Visvanathan, Rebecca E Wells, Richard B Lipton, Mia Minen, Amanda J Shallcross","doi":"10.1111/head.14857","DOIUrl":"https://doi.org/10.1111/head.14857","url":null,"abstract":"<p><strong>Objective: </strong>This study was an open-label single-arm clinical trial evaluating the fidelity, feasibility, acceptability, and clinical signal of abbreviated mindfulness-based cognitive therapy (MBCT-brief) delivered either via telephone (MBCT-T) or by video conferencing (MBCT-V) for people with migraine and comorbid depressive symptoms.</p><p><strong>Background: </strong>Migraine is commonly comorbid with elevated depressive symptoms. MBCT reduces depressive symptoms and shows promise to reduce migraine-related disability. An abbreviated and remotely delivered version of MBCT could increase access to care.</p><p><strong>Methods: </strong>People with migraine and elevated depressive symptoms were recruited from a large urban health system. Participants were assigned in blocks of eight to receive an evidence-based MBCT-brief treatment, including eight weekly group classes and home practice delivered via telephone (MBCT-T) or video (MBCT-V); MBCT-T was randomly selected for the first block. Sessions were recorded and coded for treatment fidelity. Feasibility was assessed via session attendance (primary), homework completion, recruitment rate, and survey completion rate. Acceptability was assessed via the eight-item Client Satisfaction Questionnaire (CSQ-8; primary), the Credibility/Expectancy Questionnaire (CEQ), the System Usability Scale (SUS), and items assessing survey acceptability. Participants completed the Headache Disability Inventory (HDI) and Quick Inventory of Depressive Symptomatology-Self Report 16-item (QIDS-SR<sub>16</sub>) at baseline, mid-treatment, and post-treatment. Feasibility and acceptability rates were compared to a priori benchmarks.</p><p><strong>Results: </strong>Participants (n = 16) were all female with a mean (standard deviation [SD]) age of 45 (13) years, the majority of whom identified as White (13/16, 81%) and non-Hispanic (14/16, 88%). The intervention met the a priori criteria set for therapist fidelity to treatment protocol (mean [SD] MBCT-Treatment Acceptability and Competence Scale Adherence score 2.9 [0.2]), feasibility (mean [SD] session attendance was 7.9/8 [0.3]), and acceptability (mean [SD] CSQ-8 score 28.8 [3.3]) for the entire sample and for each treatment arm. The usability of the remote-delivery system was high across study participants (mean [SD] SUS score 84.8 [11.0]). Survey procedures were broadly deemed acceptable, with at least 80% participants either endorsing \"Agree\" or \"Strongly Agree\" across all items. Using Wilcoxon tests, we observed significant reductions in both the HDI (pre-treatment median [interquartile range] score 63 [40, 70] vs. post-treatment 36 [26, 54], p = 0.004) and the QIDS-SR<sub>16</sub> (pre-treatment median [interquartile range] score 8 [5, 13] vs. post-treatment 4 [3, 6], p = 0.003).</p><p><strong>Conclusion: </strong>We found that remotely delivered MBCT-brief for migraine and depressive symptoms was feasible and acceptable to patients in both the telep","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463320","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}
HeadachePub Date : 2024-10-13DOI: 10.1111/head.14850
Amparo Ruiz-Tagle, Gina Caetano, Ana Fouto, Inês Esteves, Inês Cabaço, Nuno Da Silva, Pedro Vilela, Pedro Nascimento Alves, Isabel Pavão Martins, Raquel Gil Gouveia, Patrícia Figueiredo
{"title":"Preserved working memory performance along with subcortical modulation during peri-ictal phases in spontaneous migraine attacks.","authors":"Amparo Ruiz-Tagle, Gina Caetano, Ana Fouto, Inês Esteves, Inês Cabaço, Nuno Da Silva, Pedro Vilela, Pedro Nascimento Alves, Isabel Pavão Martins, Raquel Gil Gouveia, Patrícia Figueiredo","doi":"10.1111/head.14850","DOIUrl":"https://doi.org/10.1111/head.14850","url":null,"abstract":"<p><strong>Objective: </strong>To analyze cognitive performance and brain activation during a working memory task in patients with migraine during various phases of the migraine cycle and compare to healthy participants.</p><p><strong>Background: </strong>Cognitive difficulties reported during migraine attacks remain poorly understood, despite evidence that the lateral frontoparietal network undergoes reversible disturbances and decreased activation during attacks. Recent findings in resting state functional magnetic resonance imaging suggest that brain areas involved in this network interact with subcortical regions during spontaneous migraine attacks.</p><p><strong>Methods: </strong>In this prospective, within-subject study, 10 patients with diagnosed menstrual-related episodic migraine without aura underwent 3T functional magnetic resonance imaging assessments while performing a working memory task across four phases of the natural migraine cycle: peri-ictal (preictal, ictal, postictal) phases and interictally (between attacks). Migraine prophylaxis was an exclusion criterion. Fourteen healthy controls were assessed during the corresponding phases of their menstrual cycles.</p><p><strong>Results: </strong>The protocol was completed by 24 female participants aged 21 to 47 years: 10 with migraine (four sessions each) and 14 healthy controls (two sessions each) yielding a total of 68 analyzed datasets. Patients and controls showed similar performance on the working memory task and displayed increased brain activity in regions linked to this function, namely the middle frontal gyrus, inferior parietal lobe, and anterior cingulate cortex, during all phases of the migraine/menstrual cycle. Patients with migraine (N = 10) exhibited a significant decrease in hypothalamic activity (p = 0.007) as measured by the percent signal change (PSC) during the postictal phase compared to perimenstrual controls (N = 14), with -2 (16) and 31 (35) PSC, respectively. Comparing across the migraine cycle, the change in hypothalamic activity relative to controls in the postictal phase -0.33 (0.2) ΔPSC was significantly different from the ones in the interictal (0.006 [0.5] ΔPSC; p = 0.002) and preictal (-0.08 [0.4] ΔPSC; p = 0.034) phases.</p><p><strong>Conclusion: </strong>During a working memory task, cognition-related brain activation was present across all phases of the migraine cycle similarly to healthy control participants. Patients with migraine, however, displayed lower neural activity at the subcortical level in the postictal phase. Nonetheless, the sample size is a limitation for the generalization of our results. More research is needed to fully understand how the brain copes with cognitive demands during spontaneous migraine attacks.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463321","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}
HeadachePub Date : 2024-10-04DOI: 10.1111/head.14853
Rajinder Bhardwaj, Mary K Donohue, Jennifer Madonia, Kyle Matschke, Matt S Anderson, Beth Morris, Richard Bertz, Robert Croop, Jing Liu
{"title":"Assessment of pharmacokinetic and pharmacodynamic interactions between zavegepant and sumatriptan: A phase 1, randomized, placebo-controlled study in healthy adults.","authors":"Rajinder Bhardwaj, Mary K Donohue, Jennifer Madonia, Kyle Matschke, Matt S Anderson, Beth Morris, Richard Bertz, Robert Croop, Jing Liu","doi":"10.1111/head.14853","DOIUrl":"https://doi.org/10.1111/head.14853","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) interactions between zavegepant and sumatriptan in healthy adults.</p><p><strong>Background: </strong>Zavegepant is a high-affinity, selective, small-molecule calcitonin gene-related peptide receptor antagonist administered as a nasal spray approved in the United States for the acute treatment of migraine. Triptans, including sumatriptan, are a different class of drugs for acute migraine treatment and are associated with a risk of increased blood pressure (BP). Hence, it is important to study the drug-drug interactions between zavegepant and sumatriptan due to potential coadministration in clinical settings.</p><p><strong>Methods: </strong>This was a Phase 1, single-center, partially blind, randomized, placebo-controlled, single-arm study. Eligible participants were males aged ≥ 18 and ≤ 40 years or females aged ≥ 18 and ≤ 50 years. On Day 1, participants received sumatriptan 2 × 6 mg subcutaneous injections (1 h apart) and were then randomized (6:1 ratio) to receive zavegepant 2 × 10 mg nasal spray (1 in each nostril) or placebo on Days 2 and 3. On Day 4, zavegepant or placebo was coadministered with sumatriptan after the second sumatriptan injection. BP, PK, and safety were evaluated at pre-specified time points.</p><p><strong>Results: </strong>Forty-two participants enrolled in the study received at least one dose of any treatment and were included in the safety analyses. Forty-one participants who completed the study were included in the BP and PK analyses. The mean (standard deviation) time-weighted average (TWA) of mean arterial pressure (MAP [sumatriptan + zavegepant 87.2 (6.8) vs. sumatriptan 86.9 (6.0)]), diastolic BP (DBP [sumatriptan + zavegepant 72.3 (6.8) vs. sumatriptan 72.1 (6.2)]), and systolic BP (SBP [sumatriptan + zavegepant 116.8 (10.2) vs. sumatriptan 116.2 (8.6)]) did not change following zavegepant and sumatriptan coadministration on Day 4 compared to sumatriptan alone on Day 1. Statistical comparisons of the TWA of MAP, DBP, and SBP between sumatriptan and zavegepant coadministration and sumatriptan alone were similar; the differences observed were 0.04 mmHg for MAP (90% confidence interval [CI]: -0.69, 0.77 mmHg), 0.00 mmHg for DBP (90% CI: -0.76, 0.76 mmHg), and 0.33 mmHg for SBP (90% CI: -0.97, 1.63 mmHg). Sumatriptan PK after sumatriptan and zavegepant coadministration versus sumatriptan alone was similar; the comparison ratios were 102.5% (90% CI: 100.7%, 104.2%) for AUC<sub>0-inf</sub> and 104.1% (90% CI: 98.0%, 110.6%) for C<sub>max</sub>. A small difference in zavegepant PK exposure after sumatriptan and zavegepant coadministration versus zavegepant alone was not considered clinically relevant: the comparison ratios were 112.4% (90% CI: 103.4%, 122.3%) for AUC<sub>0-24</sub> and 96.7% (90% CI: 88.9%, 105.2%) for C<sub>max</sub>. Overall, 90% (38/42) of participants experienced ≥ 1 treatment-emergent adverse event that was m","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371628","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}
HeadachePub Date : 2024-10-04DOI: 10.1111/head.14836
Rajinder Bhardwaj, Beth Morris, Kyle T Matschke, Richard Bertz, Robert Croop, Jing Liu
{"title":"Characterization of rimegepant drug-drug interactions using the cytochrome P450 probe drugs, itraconazole, rifampin, fluconazole, and midazolam.","authors":"Rajinder Bhardwaj, Beth Morris, Kyle T Matschke, Richard Bertz, Robert Croop, Jing Liu","doi":"10.1111/head.14836","DOIUrl":"https://doi.org/10.1111/head.14836","url":null,"abstract":"<p><strong>Objective: </strong>Reported here are the results of four rimegepant phase I studies, in healthy participants, aimed at determining the in vivo potential of rimegepant (75 mg) for cytochrome P450 (CYP) 3A4-related drug-drug interactions (DDIs).</p><p><strong>Background: </strong>Rimegepant orally disintegrating tablet (Pfizer Inc., New York, NY, USA) is a calcitonin gene-related peptide receptor antagonist approved for acute treatment of migraine and preventive treatment of episodic migraine. People with migraine commonly use multiple drug treatments, with the potential for DDIs.</p><p><strong>Methods: </strong>Each study was an open-label, single-arm, single-sequence, crossover study. Rimegepant was tested as a victim drug by separate co-administration of itraconazole (a strong CYP3A4 inhibitor and P-glycoprotein inhibitor) in Study 1, rifampin (a strong CYP3A4 inducer and moderate CYP2C9 inducer) in Study 2, and fluconazole (a strong CYP2C9 inhibitor and moderate CYP3A4 inhibitor) in Study 3, and as a perpetrator drug by co-administration with midazolam (a CYP3A4 substrate) in Study 4.</p><p><strong>Results: </strong>Mean values of single-dose rimegepant maximum concentration (C<sub>max</sub>) and area under the curve from time 0 to infinity (AUC<sub>0-inf</sub>) increased with itraconazole co-administration (n = 22) by 1.42-fold (90% confidence interval [CI] 1.25-1.61) and by 4.14-fold (90% CI 3.87-4.44), respectively, and decreased with rifampin co-administration (n = 21) to 36% (90% CI 31.2-41.4%) and to 19% (90% CI 16.3-21.4%), respectively. Co-administration with fluconazole (n = 23) increased rimegepant mean AUC<sub>0-inf</sub> by 1.80-fold (90% CI 1.68-1.93), with no impact on C<sub>max</sub> (1.04-fold; 90% CI 0.94-1.15). Co-administration of rimegepant single dose (300 mg; n = 14) or multiple doses (150 mg/day; n = 14) increased the mean C<sub>max</sub> of midazolam by 1.38-fold (90% CI 1.13-1.67) and 1.53-fold (90% CI 1.32-1.78), respectively, and the AUC<sub>0-inf</sub> of midazolam by 1.86-fold (90% CI 1.58-2.19) and 1.91-fold (90% CI 1.63-2.25), respectively.</p><p><strong>Conclusions: </strong>Based on the magnitude of DDIs, these studies indicate the following: co-administration of rimegepant with a strong CYP3A4 inhibitor should be avoided; during co-administration with a moderate CYP3A4 inhibitor, another dose of rimegepant within 48 h should be avoided; co-administration of rimegepant with a strong or moderate CYP3A4 inducer should be avoided; CYP2C9 does not play a meaningful role in rimegepant metabolism; and there is no clinically meaningful CYP3A4 inhibition by rimegepant.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371629","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":"Plain Language Summary Publication: Hyperactivity of the medial thalamus in patients with photophobia-associated migraine.","authors":"Yukihisa Suzuki, Motohiro Kiyosawa, Masato Wakakura, Kenji Ishii","doi":"10.1111/head.14792","DOIUrl":"10.1111/head.14792","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1175-1176"},"PeriodicalIF":5.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859545","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}
HeadachePub Date : 2024-10-01Epub Date: 2024-08-13DOI: 10.1111/head.14812
Matthew S Robbins, Gayle R Salama, J Levi Chazen
{"title":"Advanced clinical reasoning in the diagnosis of spinal cerebrospinal fluid leaks.","authors":"Matthew S Robbins, Gayle R Salama, J Levi Chazen","doi":"10.1111/head.14812","DOIUrl":"10.1111/head.14812","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1163-1166"},"PeriodicalIF":5.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970962","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}
HeadachePub Date : 2024-10-01Epub Date: 2024-08-23DOI: 10.1111/head.14811
Delora E Denney, Aaron A Lee, Stephen H Landy, Todd A Smitherman
{"title":"Plain language summary publication: Headache-related disability as a function of migraine aura: A daily diary study.","authors":"Delora E Denney, Aaron A Lee, Stephen H Landy, Todd A Smitherman","doi":"10.1111/head.14811","DOIUrl":"10.1111/head.14811","url":null,"abstract":"","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":"1174"},"PeriodicalIF":5.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035659","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}
HeadachePub Date : 2024-10-01DOI: 10.1111/head.14784
Inga Zalia Tummoszeit, Isa Amalie Olofsson, Mona Ameri Chalmer, Alexander Pil Henriksen, Bitten Aagaard, Søren Brunak, Mie Topholm Bruun, Maria Didriksen, Christian Erikstrup, Henrik Hjalgrim, Christina Mikkelsen, Susan Mikkelsen, Sisse Rye Ostrowski, Ole Birger Vesterager Pedersen, Liam Quinn, Erik Sørensen, Henrik Ullum, Jes Olesen, Karina Banasik, Thomas Folkmann Hansen, Lisette J A Kogelman
{"title":"No association between migraine and HLA alleles in a cohort of 13,210 individuals with migraine from the Danish Blood Donor Study.","authors":"Inga Zalia Tummoszeit, Isa Amalie Olofsson, Mona Ameri Chalmer, Alexander Pil Henriksen, Bitten Aagaard, Søren Brunak, Mie Topholm Bruun, Maria Didriksen, Christian Erikstrup, Henrik Hjalgrim, Christina Mikkelsen, Susan Mikkelsen, Sisse Rye Ostrowski, Ole Birger Vesterager Pedersen, Liam Quinn, Erik Sørensen, Henrik Ullum, Jes Olesen, Karina Banasik, Thomas Folkmann Hansen, Lisette J A Kogelman","doi":"10.1111/head.14784","DOIUrl":"10.1111/head.14784","url":null,"abstract":"<p><strong>Objective: </strong>To determine the association between human leukocyte antigen (HLA) alleles and migraine, migraine subtypes, and sex-specific factors.</p><p><strong>Background: </strong>It has long been hypothesized that inflammation contributes to migraine pathophysiology. This study examined the association between migraine and alleles in the HLA system, a key player in immune response and genetic diversity.</p><p><strong>Methods: </strong>We performed a case-control study and included 13,210 individuals with migraine and 86,738 controls. All participants were part of the Danish Blood Donor Study Genomic Cohort. Participants were genotyped and 111 HLA alleles on 15 HLA genes were imputed. We examined the association between HLA alleles and migraine subtypes, considering sex-specific differences.</p><p><strong>Results: </strong>We found no association between HLA alleles and migraine, neither overall, nor in the sex-specific analysis. In the migraine subtype analysis, three HLA alleles were associated with migraine without aura; however, these associations could not be replicated in an independent Icelandic cohort (2191 individuals with migraine without aura and 278,858 controls). Furthermore, we found no association between HLA alleles and migraine with aura or chronic migraine.</p><p><strong>Conclusion: </strong>We found no evidence of an association between the HLA system and migraine, suggesting that genetic factors related to the HLA system do not play a significant role in migraine susceptibility.</p>","PeriodicalId":12844,"journal":{"name":"Headache","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142345142","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}