Carolina Headache Institute

Background & aimsIn the United States, Non-Hispanic Black (Black) people are 2–threefold more likely than Non-Hispanic White (White) people to have pregnancy complications, such as a baby with low birthweight. Multi-level, community-based interventions aimed at mitigating the impacts of interpersonal and structural racism may decrease bias, improve the quality of care, and improve pregnancy outcomes. The Accountability for Cancer Care through Undoing Racism and Equity and the Heart Health Now studies reduced disparities in cancer treatment and cardiovascular risk, respectively. The Accountability for Care through Undoing Racism and Equity for Moms Study (ACURE4Moms) was modified from these successful interventions and designed to test the impact of multi-level, community-engaged antiracism interventions delivered on disparities in low birth weight (LBW) (Aim 1), experiences with perinatal depression and experiences with discrimination in medical settings (Aim 2) and other patient-centered outcomes. We will also measure implementation barriers and facilitators (Aim 3).MethodsACURE4Moms is a 4-arm, cluster-randomized trial which has enrolled 39 prenatal practices randomized to implement the following interventions for 2 years: Arm 1–Standard Care; Arm 2—Data Accountability and Transparency; Arm 3—Community-Based Doula linkages; and Arm 4—Data and Doula interventions combined. Practice staff in Arms 2–4 will also receive quarterly Maternal Healthcare Equity Education and Training. A subgroup of 100 Black patients from each practice will participate in a longitudinal survey that measures mental health symptoms and experiences with discrimination during pregnancy and postpartum. A stakeholder advisory board including doulas, community members, and policymakers helps to make decisions regarding study design, implementation, and dissemination.Multi-level mixed models will be used to evaluate outcomes using administrative, vital records and survey data. The primary outcome is a reduction in low birth weight for Black infants. Secondary outcomes include reductions in hospitalizations and emergency department use, mental health symptoms, and experiences with discrimination during pregnancy and postpartum. Intermediate outcomes include implementation barriers and facilitators.DiscussionThe findings of the ACURE4Moms study will inform policy makers, health systems, clinicians and communities about the effectiveness of multi-level, practice-based interventions to reduce maternal health disparities and provide information regarding scalability.Trial RegistrationThis trial has been prospectively registered as (7/29/2022) with clinicaltrials.gov under the name Accountability for Care Through Undoing Racism & Equity for Moms (ACURE4Moms), Identifier: NCT05484804. URL: https://clinicaltrials.gov/ct2/show/NCT05484804.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13063-026-09514-9.

BackgroundConventional, non-specific preventive migraine treatments often demonstrate low rates of treatment persistence due to poor efficacy or tolerability. Effective, well-tolerated preventive treatments are needed to reduce migraine symptoms, improve function, and enhance quality of life. Atogepant is a migraine-specific oral calcitonin gene–related peptide receptor antagonist that is indicated for the preventive treatment of migraine in adults. This analysis evaluated the safety and tolerability profile of atogepant for the preventive treatment of migraine, including adverse events (AEs) of interest, such as constipation, nausea, hepatic safety, weight changes, and cardiac disorders.MethodsThis post hoc analysis was performed using data pooled from 2 (12-week) randomized, double-blind, placebo-controlled trials (RCTs) and 2 (40- and 52-week) open-label long-term safety (LTS) trials of oral atogepant for episodic migraine (EM).ResultsThe safety population included 1550 participants from the pooled RCTs (atogepant, n = 1142; placebo, n = 408) and 1424 participants from the pooled LTS trials (atogepant, n = 1228; standard care [SC], n = 196). In total, 643/1142 (56.3%) atogepant participants and 218/408 (53.4%) placebo participants experienced ≥ 1 treatment-emergent AEs (TEAEs) in the RCTs. In the LTS trials, 792/1228 (64.5%) of atogepant participants and 154/196 (78.6%) of SC participants experienced ≥ 1 TEAEs. The most commonly reported TEAEs (≥ 5%) in participants who received atogepant once daily were upper respiratory tract infection (5.3% in RCTs, 7.7% in LTS trials), constipation (6.1% in RCTs, 5.0% in LTS trials), nausea (6.6% in RCTs, 4.6% in LTS trials), and urinary tract infection (3.4% in RCTs, 5.2% in LTS trials). Additionally, weight loss appeared to be dose- and duration-dependent. Most TEAEs were considered unrelated to study drug and few led to discontinuation.ConclusionsOverall, atogepant is safe and well tolerated in pooled RCTs and LTS trials for the preventive treatment of EM in adults.Trial registrationClinicalTrials.gov identifiers: NCT02848326 (MD-01), NCT03777059 (ADVANCE), NCT03700320 (study 302), NCT03939312 (study 309).Graphical

Post-traumatic headache (PTH) consequent to mild traumatic brain injury (mTBI) is a complex, multidimensional, chronic neurological disorder. The purpose of this review is to evaluate the current neuroimaging studies on mTBI and PTH with a specific focus on brain networks and connectivity patterns. We present findings on PTH incidence and prevalence, as well as the latest neuroimaging research findings on mTBI and PTH. Additionally, we propose a new strategy in studying PTH following mTBI. The diversity and heterogeneity of pathophysiological mechanisms underlying mild traumatic brain injury pose unique challenges on how we interpret neuroimaging findings in PTH. Evaluating alterations in the intrinsic brain network connectivity patterns using novel imaging and analytical techniques may provide additional insights into PTH disease state and therefore inform effective treatment strategies.

To describe and compare phenotypic features of posttraumatic headaches (PTH) and headaches unrelated to concussion. Participants are a random sample of recently deployed soldiers from the Warrior Strong cohort, consisting of soldiers with (n = 557) and without (n = 1,030) a history of a recent mild traumatic brain injury (mTBI; concussion). mTBI+ soldiers were subdivided as PTH+ (n = 230) and PTH- (n = 327). Headache classification was based on a detailed phenotypic questionnaire. Medical encounters for headache were documented for the year after deployment. The findings here are limited to the soldiers with headaches, consisting of 94% of the mTBI+ soldiers and 76% of the mTBI- soldiers. Other than headache duration, all headache/migraine features were more common or more severe in the PTH+ group compared to the nonconcussed group (mTBI-) and compared to the concussed group with nontraumatic headaches (PTH-). Headaches were largely similar in the mTBI- and PTH- groups. The features most specific to PTH+ included allodynia, visual aura, sensory aura, daily headache, and continuous headache. Medical consultation for headache was most common in the PTH+ group (62%) vs the PTH- group (20%) or the mTBI- group (13%) (p < 0.008). In this cohort of recently deployed soldiers, PTHs are more severe, frequent, and migraine-like and more often associated with medical consultation compared to headaches presumed unrelated to concussion. Future observational studies are needed to verify and characterize the PTH phenotype, which could be followed by treatment trials with appropriate and possibly novel outcomes for prespecified subgroups. NCT01847040.

ObjectiveTo examine the likelihood of response with continued galcanezumab treatment in patients with episodic or chronic migraine without initial clinical improvement.BackgroundA percentage of patients with migraine may require additional time on pharmacotherapy but discontinue treatment prematurely. Additionally, recognizing when continued treatment is unlikely to provide improvement limits unnecessary exposure.MethodsPost hoc analysis of response after continued galcanezumab treatment was conducted in a subset of patients with episodic (N = 879) and chronic (N = 555) migraine who did not achieve “good” early improvement (episodic, ≥50% reduction in baseline migraine headache days [MHD] and chronic, ≥30% reduction) after 1 month of dosing (NR‐1; episodic, n = 450 and chronic, n = 306). This subset was categorized by level of reduction in MHD during 1 month of treatment: “modest” (>30% to <50% fewer MHD for episodic and >10% to <30% fewer MHD for chronic), “limited” (episodic only; >10% to ≤30% fewer MHD), or “minimal/no” early improvement (≤10% fewer MHD to ≤10% more MHD), or “worsening” (>10% more MHD). The percentages of patients having “better” (≥75% fewer MHD for episodic and ≥50% for chronic), “good,” or “little‐to‐no” (≤10% fewer MHD) response during the remaining treatment period were calculated for each category. Similarly, the subset of NR‐1 patients who did not achieve “good” early improvement after 2 months of treatment (NR‐2; episodic, n = 290 and chronic, n = 240) were categorized by level of their average monthly reduction across 1 and 2 months using similar categories.ResultsOf NR‐1 patients with episodic migraine having “modest” early improvement, 62% (96/155) achieved “good” and 20% (31/155) achieved “better” responses with continued treatment. A percentage of patients with “limited” (43%; 46/108) or “minimal/no” (34%; 29/85) early improvement, or “worsening” (20%; 20/102) achieved a “good” response after continued treatment. A percentage of NR‐1 patients with chronic migraine having “modest” early improvement achieved “good” (38%; 44/116) and “better” (13%; 15/116) responses with continued treatment. A “good” response was achieved for a percentage of patients with “minimal/no” early improvement (17%; 23/133). Similar patterns were observed for the NR‐2 subset, though percentages were lower.ConclusionsGalcanezumab‐treated patients with episodic or chronic migraine without response following 1 or 2 months of treatment appear to have a reasonable likelihood of continued improvement in months following initial treatment and this opportunity is more likely in patients showing greater early improvements. While a small percentage of patients with episodic or chronic migraine who experienced worsening in the number of MHD following initial treatment responded with continued treatment, most do not show substantial reduction in MHD. Overall benefit of therapy should be determined collaboratively between the patient and physician.

There is a strong genetic component in developing migraine. Genetic markers have been identified for several rare autosomal dominant migraine types. Migraine with and without aura has been linked to various genetic variations.

As migraine transforms from episodic to chronic, there is a commensurate need for the incorporation of behavioral interventions. Behavioral intervention reduces reliance on passive interventions. Better outcomes are achieved when behavioral therapies are included with medications. Behavioral therapies include relaxation (biofeedback, guided imagery, meditation), exercise (yoga, aerobic), and schedule management (sleep, diet). Migraine patients should set aside time in their schedule for their daily behavioral treatment.

ObjectivesTo estimate exposure to faecal contamination through drinking water as indicated by levels of Escherichia coli (E. coli) or thermotolerant coliform (TTC) in water sources.MethodsWe estimated coverage of different types of drinking water source based on household surveys and censuses using multilevel modelling. Coverage data were combined with water quality studies that assessed E. coli or TTC including those identified by a systematic review (n = 345). Predictive models for the presence and level of contamination of drinking water sources were developed using random effects logistic regression and selected covariates. We assessed sensitivity of estimated exposure to study quality, indicator bacteria and separately considered nationally randomised surveys.ResultsWe estimate that 1.8 billion people globally use a source of drinking water which suffers from faecal contamination, of these 1.1 billion drink water that is of at least ‘moderate’ risk (>10 E. coli or TTC per 100 ml). Data from nationally randomised studies suggest that 10% of improved sources may be ‘high’ risk, containing at least 100 E. coli or TTC per 100 ml. Drinking water is found to be more often contaminated in rural areas (41%, CI: 31%–51%) than in urban areas (12%, CI: 8–18%), and contamination is most prevalent in Africa (53%, CI: 42%–63%) and South-East Asia (35%, CI: 24%–45%). Estimates were not sensitive to the exclusion of low quality studies or restriction to studies reporting E. coli.ConclusionsMicrobial contamination is widespread and affects all water source types, including piped supplies. Global burden of disease estimates may have substantially understated the disease burden associated with inadequate water services.

"Do I have a tumor?" This is a question in every person's mind when first confronted with a new-onset headache, a question that causes considerable anxiety among patients, leading them to seek medical evaluation. This publication reviews the current literature with respect to the epidemiology, pathophysiology presentation, and treatment of headaches in association with intracranial neoplasm.