HIT-6 Scores Research Articles

The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study

BackgroundWe evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO).MethodsIn a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores.ResultsOf 1130 patients enrolled, 587 (51.9%) had baseline MO. Fremanezumab reduced placebo-adjusted least-squares mean (95% confidence interval) monthly HDs (− 2.2 [− 3.1 to − 1.2] and − 2.7 [− 3.7 to − 1.8]; P < 0.0001) in patients with MO and without MO (quarterly − 1.4 [− 2.3 to − 0.5], P = 0.0026; monthly − 1.4 [− 2.3 to − 0.6], P = 0.0017). Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]). Fremanezumab improved HIT-6 and MSQoL scores. Significantly more fremanezumab-treated patients reverted to no MO (quarterly 111/201 [55.2%], monthly 120/198 [60.6%]) versus placebo (87/188 [46.3%]).ConclusionsFremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO.Trial registrationClinicalTrials.gov NCT02621931 (HALO CM), registered December 12, 2012.

Efficacy of patent foramen ovale closure for treating migraine: a prospective follow-up study

This study aims to evaluate the potential of percutaneous patent foramen ovale (PFO) closure to improve the headache in patients with migraine and PFO, and discuss the difference between the...

Determining Thresholds for Meaningful Change for the Headache Impact Test (HIT-6) Total and Item-Specific Scores in Chronic Migraine.

ObjectiveThe objective of the analyses described here was to develop thresholds defining clinically meaningful response on the total and item scores of the 6‐item short‐form Headache Impact Test (HIT‐6) in a population of patients with chronic migraine (CM).BackgroundThe HIT‐6 is a short, easily understood, and useful measure of the impact of headache on daily life. Though widely used, limited literature supports a threshold value for clinically meaningful response within individuals over time for the HIT‐6 total score and for the item scores, especially in the CM population.MethodsPROMISE‐2 is a randomized, double‐blind, multicenter study comparing intravenous eptinezumab 100 and 300 mg with placebo for the preventive treatment of CM. Responder definitions for HIT‐6 total and items scores using data from PROMISE‐2 study were calculated via distribution‐based and anchor‐based methods. Distribution‐based methods included half of the baseline standard deviation and baseline standard error of measurement. The change from baseline to week 12 in HIT‐6 scores was assessed using the following anchors: patient global impression of change, reduction in migraine frequency, and change in EuroQol 5 dimensions 5 levels visual analog scale. Values from the literature and PROMISE‐2 analyses were plotted against the cumulative distribution function of change values (baseline to week 12) and used to triangulate to empirically support clinically meaningful change definitions for the HIT‐6 total and item scores in patients with CM.ResultsFrom the literature, 5 articles provided 7 candidate values for a responder threshold for the HIT‐6 total score. From distribution‐ and anchor‐based methods, 5 candidate values were derived from PROMISE‐2 data. Using the median of all candidate values, a HIT‐6 total score responder definition estimate of −6 (ie, ≥6‐point improvement in the total score) appears most appropriate for discriminating between individuals with CM who have experienced meaningful change over time and those who have not. For item‐level analyses using anchor‐based methods, the responder definition for items 1‐3 (“severe pain,” “limits daily activities,” and “lie down”) was a 1‐category improvement in response (eg, from Sometimes to Rarely); for items 4‐6 (“too tired,” “felt fed up or irritated,” and “limits concentration”), a 2‐category improvement in response (eg, from Always to Sometimes) was clinically meaningful.ConclusionsUsing a multifaceted, statistically‐based approach, the recommended responder definition for the HIT‐6 total score in the CM population is a ≥6‐point decrease, consistent with previous literature. Anchor‐based item‐level responder thresholds were defined as a decrease of 1 or 2 categories, depending on the item. These CM‐specific values will provide researchers and clinicians a means to interpret clinically meaningful change in the HIT‐6 total and item scores and may facilitate the measurement of treatment benefits in specific functional domains of the HIT‐6.

The Impact of Self-Reported Recurrent Headache on Absenteeism and Presenteeism at Work Among Finnish Municipal Female Employees.

PurposeThe aim of this cross-sectional, observational study was to determine the impact of self-reported headache on absenteeism and presenteeism in a female working-age population.Subjects and MethodsThe study population consisted of 594 Finnish female municipal employees, who answered self-administered questionnaires including sociodemographic, lifestyle, health, and work-related data. Sickness absence days were obtained from the official records of the employer. Headache recurrence was defined by asking whether headache was occasional or recurrent. Headache impact was measured by the HIT-6.ResultsIn our study, 456 (77%) females had headache, and headache was recurrent in 178 (39%). The self-reported recurrence of headache was related to age, AUDIT-C, health-rated quality-of-life, self-rated work ability, depressive symptoms, and work stress (P for linearity <0.001). They also had more depressive symptoms and work stress (P for linearity <0.001). Mental work load was highest in those with recurrent headache (P=0.042), and work engagement was highest in those without headache (P=0.038). There was no statistically significant difference in absenteeism days between the headache groups when adjusted with confounding variables. Presenteeism was associated with the recurrence of headache (P for linearity <0.001). Presenteeism and the HIT-6 score were significantly associated in the recurrent headache group (P=0.009).ConclusionHeadache was not related to absenteeism, but the self-reported recurrence of headache was clearly associated with presenteeism in this female working-age population.

Effect of Headache-Free Days on Disability, Productivity, Quality of Life, and Costs Among Individuals with Migraine.

The functional impairment associated with migraine can cause physical, emotional, and economic ramifications that can affect occupational, academic, social, and family life. Understanding the relationship between headache-free days (HFDs) and the disease burden of migraine may help with decisions regarding treatment and management of migraine. To determine the relationship between burden of disease measures and HFDs among individuals with migraine experiencing ≥ 4 headache days in the previous 30 days. The 2016 U.S. National Health and Wellness Survey (N = 97,503) was self-administered to a nationally representative sample of adults. Respondents with a migraine diagnosis who reported ≥ 4 headache days a month were included in the analysis. The primary independent variable was the number of HFDs assessed as both a continuous (HFDs in the previous 30 days) and categorical (0-10, 11-20, and 21-26 HFDs) measure. HFDs were used to predict outcomes using separate generalized linear models. Outcomes included effect on functional status and well-being, measured by the 6-item Headache Impact Test (HIT-6) score; number of days of work and/or household activities missed due to migraine; annualized indirect costs due to work productivity loss (assessed via the Work Productivity and Activity Impairment questionnaire); and annualized direct costs due to health care resource use (health care provider visits, emergency room visits, and hospitalizations). The survey included 372 respondents with diagnosed migraine and ≥ 4 headache days per month. Using HFDs as a continuous variable, each additional HFD was associated with a 0.15-point reduction in HIT-6 scores, a 5% reduction in both number of work days and household activities missed, and a 4% reduction in indirect costs; thus, a 5-day increase in HFDs would lead to a 0.75-point reduction in HIT-6 scores, 25% reduction in days of work or household activities missed, and 20% reduction in indirect costs. Analyzing HFDs as a categorical variable, respondents experiencing 21-26 HFDs had lower HIT-6 total scores than those with 0-10 HFDs (adjusted means: 66.59 vs. 63.91; P = 0.001) or those with 11-20 HFDs (65.66 vs. 63.91, P = 0.015). Respondents experiencing 21-26 HFDs missed fewer work days than those with 0-10 HFDs (4.44 vs. 1.46, P = 0.002) or those with 11-20 HFDs (3.36 vs. 1.46, P = 0.009). Similarly, respondents with 11-20 HFDs (22.99 vs. 9.72, P < 0.001) and those with 21-26 HFDs (22.99 vs. 7.34, P = 0.001) were associated with fewer days of household activities missed due to migraine compared with respondents with 0-10 HFDs. Respondents with 21-26 HFDs per month had significantly lower indirect costs ($16,975 vs. $6,919, P = 0.025) than those with 0-10 HFDs. A higher number of HFDs is associated with decreased headache-related disability among those with migraine. Interventions that increase the total number of HFDs may reduce the burden and cost associated with migraine. This study was funded by Teva Pharmaceutical Industries (Petach Tikva, Israel). Cohen is an employee of Teva Branded Pharmaceutical Products R&D (USA); Bell was employed by Teva Pharmaceutical Industries at the time of this study and has stock/stock options in Teva Pharmaceutical Industries. Lee is employed by Kantar, which received payment from Teva Pharmaceutical Industries for data analyses performed for this study. Lipton has received research support from the NIH, the Migraine Research Foundation, and the National Headache Foundation. He has reviewed for the NIA and NINDS; holds stock options in eNeura Therapeutics and Biohaven Holdings; and serves as consultant, advisory board member, or has received honoraria from the American Academy of Neurology, Alder, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir, Biohaven, Biovision, Boston Scientific, Dr. Reddy's, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta. Saikali serves on the advisory board and as speaker for Allergan, Amgen, Promius, Supernus, and Teva Pharmaceuticals. He serves as a speaker for Assertio, Avanir, Cefaly, Egalet, Eli Lilly, Gammacore, and Pernix. This study has been presented as a poster at the American Academy of Neurology 2018 Annual Meeting, April 21-27, 2018, in Los Angeles, CA; Headache Update 2017, July 13-16, 2017, in Lake Buena Vista, FL; and the American Headache Society 2017 Annual Meeting, June 8-11, 2017, in Boston, MA.

Prevalence of headache among medical students in Universitas Udayana, Denpasar, Bali-Indonesia

Introduction: Headache among medical students is common. The study from the population estimated that the prevalence of headache reached as many as 12 to 18%, depending on the type of the study. Migraine was frequently found among medical students and related to academic underachievement and limiting daily activity. We would like to identify the prevalence and nature of headache among medical students in Udayana University Denpasar, as well as its impact on their quality of life as a whole.Methods: This was an analytical cross-sectional study, involving medical students of second and sixth semester, Faculty of Medicine Udayana University. The study participants were randomized using random number generator and asked to fill in the multiple questionnaires of various parameters of headache profiles, as well as HIT6 score. All data analysis was conducted using SPSS version 20.Results: According to HIT6 questionnaire results, more than half of study participants experienced a certain impact of their headache in their life, with more than 10% of subjects felt substantial and severe implications. More than 80% of study participants experienced headache during the past one year and approximately 67% of them experienced headache within the past 1 to 3 months. The majority (50.8%) of subjects reported headache of pulsating in nature and 78% experienced headache recurrence for up to 5 times a month. Almost half of them (41.3%) experienced impaired activity to a certain extent. More than half (55%) of subjects found their headache so debilitating that they took sick leave of at least one day.Conclusion: Headache was prevalent among medical students, regardless of their age, gender, and socio-economic status. Although generally mild in intensity, given the nature of its recurrency and debilitating painful quality, medical students often took a leave of absence from class for one or more days, thus potentially impairing the quality of life and academic performance to a certain extent.

Impact of 24-Hour On-Call Shifts on Headache in Medical Residents: A Cohort Study.

During 24-hour on-call shifts medical residents are exposed to diverse circumstances such as sleep deprivation and stress. Our aim is to assess the effect of 24-hour on-call shifts on medical residents' headache-related disability. The Migraine Disability Assessment Scale (MIDAS), the Headache Impact Test (HIT-6), the Pittsburgh Sleep Quality Index (PSQI), and the Hospital Anxiety and Depression Scale (HADS) questionnaires were administered to medical residents who had never performed on-call shifts at baseline and 6 months after beginning 24-hour on-call shifts. Scores were compared. About 66 medical residents completed this study. About 21.2% (n=14) had history of migraine, 42.4% (n=28) had a history of tension-type headache (TTH) and 12.1% (n=8) had a history of both migraine and TTH. Among medical residents with migraine, the median MIDAS score was significantly higher after starting 24-hour on-call shifts than at a baseline (4.0 vs 8.0; Wilcoxon, P=.001), meaning that, on average, disability increased from little or no disability, to moderate disability. No difference in HIT-6 scores was found. The median score of PSQI and HADS was higher at 6 months (PSQI: 7.0 vs 8.0; P=.003), (HADS: 5.0 vs 8.0; P<.001) for the general group. In medical residents with migraine, migraine-related disability increased after starting 24-hour on-call shifts. We also found a worsening in depression and anxiety symptoms and self-reported sleep quality in medical residents with and without headache history.

Disrupted functional connectivity between sub-regions in the sensorimotor areas and cortex in migraine without aura

BackgroundMigraine is a severe and disabling brain disorder, and the exact neurological mechanisms remain unclear. Migraineurs have altered pain perception, and headache attacks disrupt their sensory information processing and sensorimotor integration. The altered functional connectivity of sub-regions of sensorimotor brain areas with other brain cortex associated with migraine needs further investigation.MethodsForty-eight migraineurs without aura during the interictal phase and 48 age- and sex-matched healthy controls underwent resting-state functional magnetic resonance imaging scans. We utilized seed-based functional connectivity analysis to investigate whether patients exhibited abnormal functional connectivity between sub-regions of sensorimotor brain areas and cortex regions.ResultsWe found that patients with migraineurs without aura exhibited disrupted functional connectivities between the sensorimotor areas and the visual cortex, temporal cortex, posterior parietal lobule, prefrontal areas, precuneus, cingulate gyrus, sensorimotor areas proper and cerebellum areas compared with healthy controls. In addition, the clinical data of the patients, such as disease duration, pain intensity and HIT-6 score, were negatively correlated with these impaired functional connectivities.ConclusionIn patients with migraineurs without aura, the functional connectivities between the sensorimotor brain areas and other brain regions was reduced. These disrupted functional connectivities might contribute to abnormalities in visual processing, multisensory integration, nociception processing, spatial attention and intention and dysfunction in cognitive evaluation and modulation of pain. Recurrent headache attacks might lead to the disrupted network between primary motor cortex and temporal regions and between primary somatosensory cortex and temporal regions. Pain sensitivity and patient quality of life are closely tied to the abnormal functional connectivity between sensorimotor regions and other brain areas.

PND95 EPTINEZUMAB DEMONSTRATED EARLY AND SUSTAINED REDUCTIONS IN HIT-6 TOTAL AND ITEM SCORES OVER TIME IN PATIENTS WITH CHRONIC MIGRAINE IN THE PROMISE-2 TRIAL

Eptinezumab, a monoclonal antibody inhibiting CGRP, significantly reduced migraine frequency versus placebo in patients with chronic migraine (CM) in the randomized, double-blind PROMISE-2 study (NCT02974153). This analysis describes the effects of eptinezumab on the short-form Headache Impact Test (HIT-6) total and individual item scores in patients with CM. Patients received eptinezumab 100mg (n=356), 300mg (n=350), or placebo (n=366) for 2 intravenous doses administered at baseline and Week 12. Patients rated headache impact using the HIT-6 at baseline and Weeks 4, 12, 16, 24, and 32. HIT-6 item responses were scored from 1=never to 5=always, with higher scores indicating greater life impact. Post hoc two-piece, linear mixed-effects modeling examined longitudinal changes from baseline in HIT-6 scores. P-values are from post hoc analyses without multiplicity control. Baseline headache impact was similar across treatment groups. Decreases in HIT-6 total scores from baseline to Week 4 were statistically significantly greater with eptinezumab versus placebo (p<0.0001); all groups demonstrated statistical significance versus baseline (p<0.0001). Over Weeks 4–32, all groups demonstrated stable HIT-6 total scores. At all post-baseline time points, mean HIT-6 total scores were lower in eptinezumab groups versus placebo (p<0.05). Scores for all individual items declined from baseline to Week 4 in all groups; reductions in eptinezumab groups were greater versus placebo (p<0.01). For all groups, HIT-6 item scores were generally stable over Weeks 4–32. Relative to placebo, impact levels were lower over Weeks 4–32 for all 6 items with eptinezumab 300mg (p<0.01). Scores for eptinezumab 100mg were lower than for placebo over Weeks 4–28 for 4 items and over Weeks 4–32 for 2 items (p<0.05). Eptinezumab reduced headache-related life impact over the first month following intravenous administration relative to placebo; benefits were sustained through 32 weeks with just 2 administrations of eptinezumab.

Estimating quality of life in a headache referral population based on Migraine Disability Assessment Scale and Headache Impact Test

Background: Headache is among the most common disabling neurologic disorders. We measured quality of life in chronic migraine (CM) and episodic migraine (EM), stratified by medication overuse headache (MOH) and presence of aura. Methods: In this observational study, conducted from January 2016 to December 2018, adult patients referred to the tertiary headache clinic of Sina Hospital in Tehran, Iran, who met International Classification of Headache Disorders, 3rd Edition-beta (ICHD-3 β) criteria for migraine were classified to EM and CM subtyped based on presence of aura and MOH. Validated Farsi versions of Migraine Disability Assessment Scale (MIDAS) and 6-item Headache Impact Test (HIT-6) questionnaires were used. Results: A total of 2454 patients (1907 women) were enrolled from which 1261 (51.4%) patients had EM and 1193 (48.6%) had CM, while 908 subjects (37.0%) had MOH, of whom 890 (98.0%) had CM. Median scores of MIDAS and HIT-6 were significantly higher in patients with CM compared to EM sufferers. Chronic migraineurs with MOH had a significantly higher median score of MIDAS and HIT-6 compared to patients with non-MOH CM. Also, there was a moderate positive correlation between MIDAS (disability) and HIT-6 scores (impact on patients’ life) and a moderate correlation between HIT-6 and pain severity. Conclusion: The results of this study confirm that CM and MOH are associated with a higher headache-related disability and impact on life compared to EM. Therefore, treatment goals in prevention of MOH and migraine transformation warrant higher quality of life in patients with migraine.

Early Age of Migraine Onset is Independently Related to Cognitive Decline and Symptoms of Depression Affect Quality of Life.

BackgroundPeople with migraine experience cognitive decline more often than healthy controls, resulting in a significant functional impact. Early identifying influencing factors that contribute to cognitive decline in migraineurs is crucial for timely intervention. Although migraine may onset early in childhood and early onset migraine is related to significant disability, there is no research investigating the association between the age of migraine onset and migraineurs’ cognitive decline. Therefore we aim to explore possible factors that correlate to the cognitive function of migraineurs, especially focus on age of migraine onset.Methods 531 patients with migraine were included. Data on demographics and headache-related characteristics were collected and evaluated using face-to-face interviews and questionnaires. We used the Montreal Cognitive Assessment scale to assess cognitive function. In addition, we analyzed independent correlations between cognitive decline and the age of migraine onset in patients with migraine. And all patients completed the Headache Impact Test-6 to evaluate their quality of life.ResultsMigraineurs with cognitive decline showed significant differences from those without in age (OR=1.26, P<0.0001), years of education (OR=0.89, P=0.0182), the intensity of headache (OR=1.03, P=0.0217), age of onset (OR=0.92, P<0.0001) and anxiety scores (OR=1.09, P=0.0235). Furthermore, there was no interaction in the age of onset between subgroups. Multivariate linear regression analyses of HIT-6 scores showed that the intensity of headache (β=0.18, P<0.0001) and depression scores (β=0.26, P=0.0009) had independent effects on decreased quality of life.ConclusionOur findings suggest that younger age of migraine onset is independently related to migraineurs’ cognitive decline, and migraine accompanying anxiety symptoms significantly related to decreased quality of life in migraineurs.

Clinical Outcomes Following Surgical Ligation of Cerebrospinal Fluid-Venous Fistula in Patients With Spontaneous Intracranial Hypotension: A Prospective Case Series.

Cerebrospinal fluid-venous fistula (CVF) is a recently described cause of spontaneous intracranial hypotension (SIH). Surgical ligation of CVF has been reported, but clinical outcomes are not well described. To determine the clinical efficacy of surgical ligation for treatment of CVF. Outcomes metrics were collected in this prospective, single-arm, cross-sectional investigation. Inclusion criteria were as follows: diagnosis of SIH, demonstration of CVF on myelography, and surgical treatment of CVF. Pre- and postoperative headache severity was assessed with the Headache Impact Test (HIT-6), a validated headache scale ranging from 36 (asymptomatic) to 78 (most severe). Patient satisfaction with treatment was measured with Patient Global Impression of Change (PGIC). Twenty subjects were enrolled, with mean postoperative follow-up at 16.0±9.7 mo. All CVFs were located in the thoracic region (between T4 and T12). Pretreatment headache severity was high (mean HIT-6 scores 65±6). Surgical treatment resulted in marked improvement in headache severity (mean HIT-6 change of -21±-9, mean postoperative HIT-6 of 44±8). Of subjects with baseline headache scores in the most severe category, 83% showed a major improvement in severity (transition to the lowest 2 severity categories) after surgery. All subjects (100%) reported clinically significant levels of satisfaction with treatment (PGIC score 6 or 7); 90% reported the highest level of satisfaction. There were no short- or long-term complications or 30-d readmissions. Surgical ligation is highly effective for the treatment of SIH due to CVF. Larger controlled trials with longer follow-up period are indicated to better assess its long-term efficacy and safety profile.

Clinical factors influencing the impact of cluster headache from a prospective multicenter study

Although many patients with cluster headaches (CH) are disabled by their condition, few studies have examined this in detail. This cross-sectional, multicenter observational study prospectively collected demographic and clinical questionnaire data from 224 consecutive patients with CH. We assessed headache impact using the six-item Headache Impact Test (HIT-6) and evaluated the factors associated with the impact of CH. Participants with a HIT-6 score ≥ 60 were classified into a severe impact group. The majority (190, 84.8%) of the participants were classified into the severe impact group. These patients were characterized by younger age, earlier onset of CH, longer duration of each headache attack, higher pain intensity, more cranial autonomic symptoms, a higher proportion of depression or anxiety, higher score of stress, and lower score of quality of life. The anxiety (OR = 1.19, 95% CI: 1.08–1.31, p = 0.006), greater pain intensity (OR = 1.06, 95% CI: 1.02–1.10, p = 0.002), and age (OR = 0.99, 95% CI: 0.99–1.00, p = 0.008) were significant predictors for a severe impact of CH patients. According to the HIT-6 results, most of the CH patients were significantly affected by CH. As well as pain intensity, anxiety and age modulated CH’s impact on their lives.

The role of left prefrontal transcranial magnetic stimulation in episodic migraine prophylaxis

ObjectiveThe aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.MethodsA randomized double-blinded placebo-controlled study was designed to assess the effect of 5 Hz rTMS applied over the left dorsolateral prefrontal cortex (LDLPFC ) in 33 migraineurs. Patients were followed up for 1 month before receiving rTMS, and for another month after the sessions by a headache diary. The primary outcome measure was the achievement of 50% reduction in the number of migraine attacks. Secondary outcome measures included migraine days, assessment of migraine attack severity, disability by HIT-6, and side-effects to the procedure.ResultsThe study revealed that 69.2% of the active treatment group achieved 50% or more reduction in the number of migraine attacks versus 25% of cases in the control group (p = 0.02). The absolute number of migraine attacks was reduced by 3.1 vs 1.5 in the active and control group, respectively. The number of cases with severe HIT-6 scores was reduced by 46.2% in active treatment group versus a 7.1% reduction in the control group (p = 0.02).ConclusionHigh-frequency rTMS applied to LDLPFC can reduce the number of migraine attacks by 50% or more in almost 70% of a sample of episodic migraineurs with a concomitant decrease in functional disability.Trial registrationClinicalTrials.gov, Identifier: NCT04031781. Registered 23 July 2019—retrospectively registered at https://clinicaltrials.gov/ct2/show/NCT04031781?term=Migraine+Prophylaxis&recrs=ce&type=Intr&cond=Migraine&rank=9

Patient-Reported Outcome in Two Chronic Diseases: A Comparison of Quality of Life and Response Profiles in Severe Migraine and Severe Asthma.

IntroductionMigraine and asthma are two frequent, disabling, chronic disorders with a major impact on patient well-being. The objectives of this study were to compare subjective well-being between patients with severe forms of migraine or asthma using a panel of PROs.MethodsAdult patients were recruited during routine consultations with chest physicians or neurologists. Patients with severe migraine (reporting headaches on ≥8 days/month and having failed ≥2 prophylactic treatments) and patients with severe asthma (according to the 2017 GINA definition: requiring Step 4 or 5 treatment or presenting uncontrolled symptoms) were eligible. Each patient completed the EuroQol Questionnaire (EQ-5D-5L), the Work Productivity and Activity Impairment Questionnaire (WPAI) and the Hospital Anxiety and Depression scale (HAD). Patients with severe migraine the 6-item Headache Impact Test (HIT-6) and those with severe asthma completed the Asthma Control Test (ACT).Results249 patients with severe migraine and 96 with severe asthma were enrolled. Mean EQ-5D-5L utility scores were significantly higher in the severe migraine group than in the severe asthma group (0.75±0.25 vs 0.68±0.26; p<0.01). Low EQ-5D-5L utility scores were associated with frequent (≥15 headache days/month) or disabling (HIT-6 score ≥60) headaches and with poor asthma control. Patients with severe migraine more frequently presented a HAD depression score ≥11 (23.0% in severe migraine; 7.5% in severe asthma; p<0.01), whereas those with severe asthma more frequently reported problems with mobility, self-care and usual activities. Absenteeism (percent worktime missed) was similar in both groups (severe migraine: 9.0%±19.1%; severe asthma: 13.8%±22.9%) but work impairment was higher in the severe migraine group (44.3% vs 28.4%; p<0.01).ConclusionQuality of life, work activity and psychological distress are all deteriorated in both severe migraine and severe asthma. Different aspects are affected in the two diseases: a greater impact on psychological aspects in severe migraine and a greater impact on physical aspects in severe asthma.

Abstract TP169: Migraine Phenotypic Spectrum in a CADASIL Cohort: Mayo Clinic Florida

Objective: To characterize migraine in patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). Background: CADASIL serves as a key model of a monoallelic stroke disease. A portion of patients have coexistent migraine with aura, yet the relationship between migraine and the pathophysiology of CADASIL is poorly understood. Design/Methods: We performed a prospective study of adults with a confirmed genetic diagnosis of CADASIL, age-matched controls with migraine with aura (MA), and headache-free controls. The Migraine Disability Assessment Questionnaire (MIDAS) and Headache Impact Test (HIT-6) were used to quantify migraine-related disability. Subjects were followed for one year after enrollment. Results: We enrolled 88 subjects, which included 33 subjects with CADASIL, 32 subjects without CADASIL but with MA, and 23 control subjects without CADASIL or MA. Mean age was 53.6 (range, 22-86), 64.8% (57/88) were females, and 83% (73/88) were white. Of the CADASIL subjects, 61% (20/33) suffered from MA (CAD/+MA). Aura semiology amongst the CAD/+MA and MA patients were as follows: visual (80% vs 81%), sensory (75% vs 81%), speech (75% vs 50%), motor (30% vs 50%), brain stem (60% vs 81%) and retinal (30% vs 25%). Mean MIDAS scores at enrollment were comparable between the CAD/+MA and MA populations (32.3 vs 33.5), as were mean HIT-6 scores (56.3 vs 56.9). Discussion: These preliminary results do not show a significant difference in migraine disability between CADASIL migraineurs and chronic migraineurs. Minor differences were observed in aura distribution between the two groups, although further investigations are needed to better understand the underlying pathology of CADASIL and migraine.

Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine.

Introduction:The Headache Impact Test (HIT-6) is a self-report questionnaire designed to evaluate the impact of headache on quality of life. The aim of this study is to assess reliability and validity of Turkish version of HIT-6 questionnaire in patients with migraine.Methods:A total of 114 patients with migraine were included in this multicenter, prospective, descriptive study conducted at two consecutive visits 4 weeks apart. Comprehensibility, patient-physician reliability, internal consistency, test-retest reliability and validity of the translated HIT-6 were analyzed.Results:Patients identified that HIT-6 items were “well-understood” in both visit 1 (ranged from 88.6% to 95.7%) and visit 2 (ranged from 93.0% to 98.2%). A highly positive correlation (R=0.876, p<0.001) was noted between visit 1 scores related to self-administered and physician-administered HIT-6 scores. Internal consistency analyzed via Cronbach’s α values for visit 1 and visit 2 HIT-6 scores in all patients were 0.753 (acceptable) and 0.864 (excellent), respectively. HIT-6 scores of patients (64.13 (6.20) and 62.70 (7.04), at visits 1 and 2, respectively, p=0.07) showed a moderate test-re-test reliability (R=0.437, p=0.0004). The HIT-6 score positively correlated with visit 1 and visit 2 headache severity-Likert scale (R=0.451 and 0.478, respectively, p<0.001) and VAS (R=0.365 and 0.531, respectively p<0.001) scores, and with visit 2 headache days for a month (R=0.215, p=0.022).Conclusion:These results demonstrated that the Turkish translation is equivalent to English version of HIT-6 in terms of internal consistency and it has moderate test-retest reliability and validity as correlated with headache severity, VAS and headache days for a month.

Transcatheter Patent Foramen Ovale Closure Is Effective in Alleviating Migraine in a 5-Year Follow-Up.

Background: The association between patent foramen ovale (PFO) and migraine has been reported. However, whether transcatheter PFO closure is effective in alleviating migraine remains controversial. The objective of this study was to investigate the efficacy of PFO closure in alleviating migraine in a 5-year follow-up.Methods: Migraineurs with PFO from 2013 to 2015 were included and divided into PFO closure group and non-PFO closure group according to their therapy. Contrast-enhanced transcranial Doppler (c-TCD) was performed to evaluate the degree of the right-to-left shunt (RLS), and headache impact test (HIT-6) questionnaire was administered to assess the disability of migraine at 1- and 5-year follow-up.Results: Of 192 patients, 91 patients underwent PFO closure, and 101 patients refused. The HIT-6 scores of patients in the PFO closure group were significantly lower than those of the non-PFO closure group at both 1- and 5-year follow-up. These results were more pronounced in patients younger than 45 years. Furthermore, in patients with large RLS, the HIT-6 scores of patients in the PFO closure group were significantly lower at both 1- and 5-year follow-up compared with those of the non-PFO closure group. However, in patients with moderate RLS, this difference was significant only at 5-year follow-up.Conclusions: PFO closure is effective in alleviating migraine in the long term. This effect is more obvious when patients are younger than 45 years and RLS is large.

Depression Among Patients with Chronic Cluster Headaches.

Introduction: Chronic headaches account for a significant proportion of people leading a poor quality of life. Chronic cluster headaches can be defined as episodes of headache usually around the eye in the pattern of a cluster lasting 15-180 minutes each followed by multiple similar episodes occurring at a frequency of 1-8 times per day.Method: This cross-sectional study was conducted in Jinnah Postgraduate Medical Center, Karachi. One hundred patients who were diagnosed cases of chronic cluster headaches were asked to fill the Beck Hopelessness Scale (BHS), Headache Impact Test (HIT), and Hospital Anxiety and Depression Scale (HADS).Results: Of our study subjects, 57 were males and 43 were females. The mean HIT-6 score among these patients was found to be 60.5±7.67 (p-value = 0.04). The mean BHS score among these patients was found to be 13±6.87. The mean HADS reporting anxiety (HADS-A) was found to be 12.54 ± 5.65; whereas, the mean HADS reporting depression (HADS-D) was found to be 7.65 ± 4.65.Conclusion: Patients with chronic cluster headaches have higher scores than the general population. There is an association between headache syndromes and depression which require further investigation.

Altered Spontaneous Activity and Functional Connectivity in the Posterior Pons of Patients With Migraine Without Aura

The brainstem has been discussed as the main player in the pathogenesis of migraine. Dysfunctional brainstem nuclei and their abnormal connections to other key brain centers may contribute to headache and other symptoms of migraine. In the present study, 32 patients with migraine without aura (MWoA) and 32 age- and sex-matched healthy controls (HCs) underwent resting-state fMRI scans. We used masked independent analysis (mICA) to investigate whether patients with MWoA exhibited abnormal brainstem nuclei-cortical functional connectivity (FC). The mICA can suppress adjacent physiological noise and prevent results from being driven by the much stronger signals of the surrounding structures. Regional homogeneity (ReHo) was used to investigate whether the brainstem regions with abnormal FC to other brain areas exhibited abnormal regional neuronal activity. Patients with MWoA showed significantly weaker FC between the posterior pons and the left superior parietal lobule, the left middle temporal gyrus, and the left middle frontal gyrus. Furthermore, patients with MWoA exhibited significantly decreased ReHo values in the posterior pons compared with HCs, and the posterior pons ReHo value was significantly negatively correlated with HIT-6 scores in the MWoA group. Patients with MWoA exhibited functional abnormalities in the posterior pons and weakened connections between the posterior pons and several key cortical brain areas involved in pain processing during the resting state. PerspectiveThis study provided increased evidence that the pons is involved in the pathophysiological mechanism of migraine, and weakened connections suggest that the touch and pain sensation of migraine sufferers may not be properly relayed to cortical processing areas, which may be associated with the pathogenesis of MWoA.