Does pain self-efficacy predict, moderate or mediate outcomes in people with chronic headache; an exploratory analysis of the CHESS trial.

BACKGROUND: Chronic headache disorders are disabling. The CHESS trial studied the effects of a short non-pharmacological intervention of education with self-management support for people affected by migraine and/or tension type headache for at least 15 days per month for at least three months. There were no statistically significant effects on the Headache Impact Test-6 (HIT-6) at 12-months. However, we observed improvement in pain self-efficacy questionnaire (PSEQ) and short-term HIT-6. We explored the impact of the CHESS intervention on PSEQ, and subsequently, on the HIT-6 and chronic headache quality of life questionnaire (CH-QLQ) at four, eighth and 12 months. METHODS: We included all 736 participants from the CHESS trial. We used simple linear regression models to explore the change of HIT-6 and CH-QLQ with treatment and PSEQ at baseline (predictor analysis), and the interaction between treatment and baseline PSEQ (moderator analysis). We considered the change of PSEQ from baseline to four months as a mediator in the mediation analysis. RESULTS: Baseline PSEQ neither predicted nor moderated outcomes. The prediction effect on change of HIT-6 from baseline to 12 months was 0.01 (95% CI, -0.03 to 0.04) and the interaction (moderation) effect was -0.07 (95% CI, -0.15 to 0.002). However, the change of PSEQ from baseline to 4-month mediated the HIT-6 (baseline to 8-, and 12-month) and all components of CH-QLQ (baseline to 8-, and 12-month). The CHESS intervention improved the mediated variable, PSEQ, by 2.34 (95% CI, 0.484 to 4.187) units and this corresponds to an increase of 0.21 (95% CI, 0.03 to 0.45) units in HIT-6 at 12-months. The largest mediated effect was observed on the CH-QLQ Emotional Function, an increase of 1.12 (95% CI, 0.22 to 2.20). CONCLUSIONS: PSEQ was not an effective predictor of outcome. However, change of short-term PSEQ mediated all outcomes, albeit minimally. Future behavioural therapy for chronic headache may need to consider how to achieve larger, and more sustained increases level of self-efficacy than that achieved within the CHESS trial. TRIAL REGISTRATION: ISRCTN79708100.

Eating attitudes of migraine patients in Turkey: a prospective multi-center study.

BACKGROUND: Migraine is a disease characterized by headache attacks. The disease is multifactorial in etiology and genetic and environmental factors play role in pathogenesis. Migraine can also be accompanied by psychiatric disorders like neurotism and obsessive compulsive disorder. Stress, hormonal changes and certain food intake can trigger attacks in migraine. Previous studies showed that eating attitudes and disorders are prevalant in patients with migraine. Eating disorders are psychiatric disorders related to abnormal eating habits. Both migraine and eating disorders are common in young women and personality profiles of these patient groups are also similar. A possible relationship which shows that migraine and eating habits are related can lead to a better understanding of disease pathogenesis and subsequently new therapeutic options on both entities. Association of migraine in relation to severity, depression and anxiety and eating habits and disorders were aimed to be investigated in this study. METHODS: The study was designed as a prospective, multi-center, case control study. Twenty-one centers from Turkey was involved in the study. The gathered data was collected and evaluated at a single designated center. From a pool of 1200 migraine patients and 958 healthy control group, two groups as patient group and study group was created with PS matching method in relation to age, body-mass index, marital status and employment status. Eating Attitudes Test-26 (EAT-26), Beck's Depression Inventory (BDI) and Beck's Anxiety Inventory (BAI) were applied to both study groups. The data gathered was compared between two groups. RESULTS: EAT-26 scores and the requirement for referral to a psychiatrist due to symptoms related to eating disorder were both statistically significantly higher in patient group compared to control group (p = 0.034 and p = 0.0001 respectively). Patients with migraine had higher scores in both BDI and BAI compared to control group (p = 0.0001 and p = 0.0001 respectively). Severity of pain or frequency of attacks were not found to be related to eating attitudes (r:0.09, p = 0.055). CONCLUSIONS: Migraine patients were found to have higher EAT-26, BDI and BAI scores along with a higher rate of referral to a psychiatrist due to symptoms. Results of the study showed that eating habits are altered in migraine patients with higher risk of eating disorders. Depression and anxiety are also found to be common amongst migraine patients.

Influence of Role Expectancy on Patient-Reported Outcomes Among Patients With Migraine: A Randomized Clinical Trial.

Importance: It is usually assumed that an individual's classification as a patient or a healthy person is determined by the presence or absence of disease, but little is known about whether the mere awareness of being a patient or a healthy control can play an important role for reporting outcomes. Objective: To investigate whether assignment to the role of a patient or a healthy control has an effect on patient-reported outcomes. Design, Setting, and Participants: This single center, double-blind, 3-group randomized clinical trial included consecutive patients from a tertiary headache clinic based at a single center in Germany who were invited to participate between October 2019 and June 2023. Statistical analysis was performed from January to March 2024. Intervention: Patients with migraine were randomized into 2 groups. The first group was told that this study was centered on migraine symptoms, whereas the second group was told that healthy controls were being sought for a study about patients with vertigo. A third group of age- and sex-matched headache-free participants served as controls. All participants viewed 2 standardized roller coaster videos and provided ratings of their perceived levels of motion sickness and dizziness. Main Outcomes and Measures: The primary outcome was self-reported vestibular symptoms. Secondary outcomes included differences in motion sickness, headache burden, and migraine disability. Outcomes were assessed using standardized questionnaires. Results: The final sample included 366 participants: 122 patients with migraine assigned the role of patient (MP) (migraine as patient): mean [SD] age, 37.56 [12.93] years; 105 [86.1%] female), 122 patients with migraine assigned the role of healthy participant (MH) (migraine as healthy): mean [SD] age, 37.03 [13.10] years; 107 [87.7%] female), and 122 headache-free controls (HC): mean [SD] age, 37.55 [11.56] years; 100 [82.0%] female). The assigned role of the individuals with migraine (MP vs MH) had a significant effect on self-disclosure of (1) estimation that symptoms (dizziness) will occur under specific conditions (self-reported vestibular symptoms: 79 MP [64.8%]; 29 MH [23.8%]; 9 HC [7.4%]; P < .001), (2) the increase of such symptoms (dizziness) after viewing the roller coaster video, and (3) the reported frequency (median [IQR] self-reported monthly headache days for MP: 7 [4-15] days; for MH: 5 [2-10] days; P = .008) and severity (median [IQR] migraine disability assessment score for MP: 35 [20-64] points; for MH: 25 [11-47] points; P = .005) of migraine symptoms. Statistically significant changes were also found for self-reported headache frequency and disability caused by migraine. Conclusions and Relevance: This randomized clinical trial found an effect of expectations regarding the role of a patient with respect to clinical and study outcomes. These findings suggest that role expectations should be taken into account when, for example, invasive treatments are discussed. Trial Registration: ClinicalTrials.gov Identifier: NCT06322550.

Using the common-sense model of illness representations to explore individuals' experiences and perceptions of migraine and its management in the United Kingdom.

OBJECTIVES: Migraine is considered a chronic health condition that impacts both quality of life and psychological wellbeing. People with migraines use a range of management strategies, which include pharmacological and non-pharmacological treatments. The aim of this study was to explore individuals' experiences and perceptions of migraines and its treatment using the Common-Sense Model (CSM) of Illness Representations. METHODS: Semi-structured, one-to-one interviews were conducted with eleven individuals with a history of migraine to explore their experiences and perceptions of migraine and its treatment. Participants were recruited from across the United Kingdom via convenience sampling using social media advertisement. Interviews were recorded, transcribed verbatim, and qualitative data were analysed using theoretical framework analysis using the CSM. RESULTS: The three dimensions of the CSM were mapped on to the qualitative data. These were: (i) Cognitive representations of migraine, within five domains: (a) identity of migraine, (b) perceived causes, (c) perceived timeline, (d) perceived control/cure, and (e) perceived consequences; (ii) Emotional representations of migraine relating to (a) migraine specific emotions and (b) emotional representation of the impact of migraine; and (iii) Coping/self-management behaviours, namely (a) self-medicating behaviours and (b) care-seeking behaviours. No incongruous data were found; therefore, no further thematic analysis was required. CONCLUSION: This is the first study to apply the CSM to migraine for framework analysis of qualitative data in this way. The findings illustrate the emotional impact of migraine and the range of illness perceptions associated with appropriate self-management. The data will be used to design a questionnaire for quantitative studies to investigate the extent to which these perceptions are generalizable to the wider population of people who experience migraines.

Anxiety and depressive symptoms and migraine-related outcomes in children and adolescents.

OBJECTIVE: The objective of this study was to explore the longitudinal relationship between anxiety and depressive symptoms and migraine outcomes in children and adolescents. BACKGROUND: Children and adolescents with migraine experience more anxiety and depressive symptoms than their peers without migraine, but it is unknown if these symptoms are associated with differential migraine outcomes. METHODS: In this prospective clinical cohort study, children and adolescents aged 8.0-18.0 years with migraine completed headache questionnaires and validated measures of anxiety and depressive symptoms (Patient-Reported Outcomes Measurement Information System) at an initial consultation and at their first follow-up visit with a neurologist. Changes in monthly headache frequency and changes in migraine-related disability (Pediatric Migraine Disability Assessment) were tracked at each time point. The relationships between these migraine outcomes and anxiety and depressive symptoms were estimated using models controlling for sex, age, headache frequency, and treatment type. RESULTS: There were 123 consenting participants. In models adjusted for age, sex, baseline disability score, and treatment type, baseline anxiety and depressive symptom levels were not significantly associated with change in headache frequency (for anxiety symptoms: ß = -0.05, 95% confidence interval [CI] = -0.268 to 0.166, p = 0.639; for depressive symptoms: ß = 0.14, 95% CI = -0.079 to 0.359, p = 0.209). Similarly, in models adjusted for age, sex, baseline headache frequency, and treatment type, the change in disability was not associated with baseline anxiety (ß = -0.45, 95% CI = -1.69 to 0.78, p = 0.470), nor with baseline depressive symptom scores (ß = 0.16, 95% CI = -1.07 to 1.40, p = 0.796). In post hoc exploratory analyses (N = 84 with anxiety and N = 82 with depressive symptom data at both visits), there were also no significant associations between change in mental health symptoms and change in headache frequency (for anxiety symptoms: ß = -0.084, 95% CI = -0.246 to 0.078, p = 0.306; for depressive symptoms: ß = -0.013, 95% CI = -0.164 to 0.138, p = 0.865). Similarly, the change in disability scores between visits was not related to the change in anxiety (ß = 0.85, 95% CI = -0.095 to 1.78, p = 0.077) nor depressive symptom scores (ß = 0.32, 95% CI = -0.51 to 1.15, p = 0.446). CONCLUSION: Baseline anxiety and depressive symptom levels were not associated with longitudinal migraine outcomes and neither were longitudinal changes in anxiety and depressive symptom levels; this contradicts popular clinical belief that mental health symptoms predict or consistently change in tandem with migraine outcomes.

Sense of direction in vestibular disorders.

BACKGROUND: Our sense of direction (SOD) ability relies on the sensory integration of both visual information and self-motion cues from the proprioceptive and vestibular systems. Here, we assess how dysfunction of the vestibular system impacts perceived SOD in varying vestibular disorders, and secondly, we explore the effects of dizziness, migraine and psychological symptoms on SOD ability in patient and control groups. METHODS: 87 patients with vestibular disorder and 69 control subjects were assessed with validated symptom and SOD questionnaires (Santa Barbara Sense of Direction scale and the Object Perspective test). RESULTS: While patients with vestibular disorders performed significantly worse than controls at the group level, only central and functional disorders (vestibular migraine and persistent postural perceptual dizziness), not peripheral disorders (benign-paroxysmal positional vertigo, bilateral vestibular failure and Meniere's disease) showed significant differences compared to controls on the level of individual vestibular groups. Additionally, orientational abilities associated strongly with spatial anxiety and showed clear separation from general dizziness and psychological factors in both patient and control groups. CONCLUSIONS: SOD appears to be less affected by peripheral vestibular dysfunction than by functional and/or central diagnoses, indicating that higher level disruptions to central vestibular processing networks may impact SOD more than reductions in sensory peripheral inputs. Additionally, spatial anxiety is highly associated with orientational abilities in both patients and control subjects.

Gender-related stress factors and emotional perception in migraine: a structured online questionnaire in migraine patients and controls.

BACKGROUND: While migraine is markedly prevalent in women, gender-related phenotype differences were rarely assessed. For this reason, we investigated, through a multicenter observational cross-sectional study, based on an online questionnaire, gender-related differences in stress factors, emotions, and pain perception in migraine patients and controls and their impact on migraine severity. METHODS: The study was designed as an online questionnaire. The link was emailed to healthy subjects (C) and migraine patients (MIG) (age 18-75, education ≥ 13 years) recruited during the first visit in 8 Italian Headache Centers adhering to Italian Society for Headache Study (SISC). The questionnaire included personal/social/work information, the Perceived Stress Scale, the Romance Quality Scale, the Emotion Regulation Questionnaire, the Beck Anxiety Inventory, the Body Perception Questionnaire, the pain perception, and a self-assessment of migraine severity in the last 3 months. RESULTS: 202 MIG and 202 C completed the survey. Independently from gender, migraine was characterized by higher pain sensitivity and more severe partner relationships. The female gender, in MIG, exhibited higher anxiety scores, body awareness, and reduced emotional suppression. Body awareness and emotional suppression were discriminating factors between genders in control and migraine groups without relevant influence on disease features. Perceived perception of migraine severity was similar between genders. CONCLUSION: Gender-related emotional and stress factors did not contribute to delineate a distinct phenotype in migraine men and women. The possible impact of emotional and stress factors characterizing genders could be considered for a single case-tailored therapeutic approach.

Cognitive Behavioral Therapy for the Management of Episodic Migraine.

PURPOSE OF REVIEW: This article provides an overview of the application of CBT in the management of episodic migraine while also providing context and insight into the underlying neurophysiological mechanisms of therapeutic change. It discusses the theoretical foundations of CBT and highlights key components including education, cognitive restructuring, behavioral interventions, relaxation techniques, and lifestyle changes. RECENT FINDINGS: Cognitive behavioral therapy (CBT) is an empirically based treatment that is well suited for the management of episodic migraine. Although first-line treatments of migraine are typically pharmacological, a review of empirical literature suggests growing evidence for the use of CBT as a standard non-pharmacological treatment of headache conditions. In summary, this article explores evidence supporting the efficacy of CBT in reducing the frequency, intensity, and duration of migraine attacks as well as improving the quality of life and psychological well-being of those with episodic migraine.

Conceptualising migraine attacks from a biopsychosocial model using qualitative and functional behavioural analysis.

OBJECTIVE: The aim of this study was to explore patients' experiences and management of pain in connection with a migraine attack in episodic migraine. DESIGN, SETTING AND SUBJECTS: This qualitative study used a semi-structured interview format based on functional behavioural analysis as commonly used in cognitive behavioural therapy. We interviewed eight participants and analysed their responses using systematic text condensation. RESULTS: Participants' descriptions of their experiences and management of pain from episodic migraine were sorted into three description First physical sensations, Automatic reactions and Acts according to the interpretation. CONCLUSION: From a biopsychosocial perspective, a migraine attack is much more complex than just an experience of pain. The purely biological pain prompts a number of automatic reactions leading to strategies for pain management.

Functional behavioural analysis can increase our understanding of experiences during a migraine attack from a biopsychosocial pain perspective.Several pain mechanisms appear to be relevant during the experience of a migraine attack than are described in the diagnostic criteria for migraine.Pain management consists of a chain of behaviours, approaches to the migraine attack and medication and the consequences of pain management.Knowledge and understanding of patients' experiences of pain and pain management during a migraine attack is an important tool in the biopsychosocial model.

Psychological Approaches for Migraine Management.

Migraine headaches are among the most prevalent and disabling pain conditions worldwide. Best-practice migraine management is multidisciplinary and includes the psychological approaches to address cognitive, behavioral, and affective factors that worsen pain, distress, and disability. The psychological interventions with the strongest research support are relaxation strategies, cognitive-behavioral therapy, and biofeedback, though the quality of clinical trials for all psychological interventions needs continued improvement. The efficacy of psychological interventions may be improved by validating technology-based delivery systems, developing interventions for trauma and life stress, and precision medicine approaches matching treatments to patients based on specific clinical characteristics.

The Objective Assessment of Event-Related Potentials: An Influence of Chronic Pain on ERP Parameters.

The article presents an original method for the automatic assessment of the quality of event-related potentials (ERPs), based on the calculation of the coefficient ε, which describes the compliance of recorded ERPs with some statistically significant parameters. This method was used to analyze the neuropsychological EEG monitoring of patients suffering from migraines. The frequency of migraine attacks was correlated with the spatial distribution of the coefficients ε, calculated for EEG channels. More than 15 migraine attacks per month was accompanied by an increase in calculated values in the occipital region. Patients with infrequent migraines exhibited maximum quality in the frontal areas. The automatic analysis of spatial maps of the coefficient ε demonstrated a statistically significant difference between the two analyzed groups with different means of migraine attack numbers per month.

The relationship between meaning of life, perceived social support, spiritual well-being and pain catastrophizing with quality of life in migraine patients: the mediating role of pain self-efficacy.

BACKGROUND: Migraine is a neurological disease that has several physical and psychological complications, which is characterized by disability and impaired quality of life. AIMS: The aim of this study was to explore the mediating role of pain self-efficacy in the relationship between meaning of life, perceived social support, spiritual well-being and pain catastrophizing with quality of life in migraine sufferers. The relationship between these factors with quality of life (QOL) was not fully explored in migraine patients. METHOD: This study was a correlational study of structural equations. Therefore, 300 patients with migraine who referred to one of the specialized neurological treatment centers in Zanjan in 2021 were recruited based on the inclusion criteria. Patients also completed the World Health Organization Quality of Life Scale (WHOQOL-BREF), Meaning in Life Questionnaire, Multidimensional Scale of Perceived Social Support, Spiritual Well-Being Scale, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire. Finally, the hypotheses were then analyzed with correlation coefficient and path analysis method by using SPSS-26 and LISREL-10.2 programs. RESULTS: The results of the present study showed that pain self-efficacy has a mediating role in the relationship between meaning of life and quality of life (B = 0.015), perceived social support with quality of life (B = 0.022), spiritual well-being with quality of life (B = 0.021), as well as pain catastrophizing with quality of life (B = - 0.015). CONCLUSION: According to the results of this study, by considering the role of self-efficacy of pain, it is possible to develop the programs to strengthen and improve the meaning of life, perceived social support, spiritual well-being and also reduce pain catastrophizing, in order to improve the quality of life of patients with migraine.

Cognitive impairment in chronic migraine compared to pseudotumor cerebri.

INTRODUCTION: We aimed to define the prevalence of objective cognitive impairment in a group of chronic migraineurs, and to define how migraineurs with cognitive impairment differed from those without impairment, and in doing so to compare cognitive impairment in chronic migraine to another chronic headache-related disorder already associated with cognitive impairment (i.e. pseudotumor cerebri syndrome). OBJECTIVES: Cognitive impairment in migraine, especially chronic migraine, has been too little studied. Only a few studies have been done, demonstrating that cognitive impairment exists in chronic migraineurs. It is not known how this compares to other headache-related conditions. MATERIAL AND METHODS: We administered a cognitive battery consisting of the National Adult Reading Test, Mini-Mental Status Examination, Digit Span, Boston Naming Test, Rey Auditory Verbal Learning Test, Trail Making Test, Controlled Oral Word Association, and Category Fluency. Cognitive impairment was defined as mild single-domain with one test score, and mild multi- -domain with two scores more than two standard deviations below the mean for age-, gender-, and education-adjusted norms. The data from this study was compared to our previously published population of patients with pseudotumor cerebri syndrome. RESULTS: One hundred prospectively recruited patients with chronic migraine were enrolled. Fifty-seven patients had normal cognitive profiles. Forty-three patients demonstrated mild cognitive impairment, and more than half (n = 24) showed impairment in multiple cognitive domains. Migraineurs with multi-domain impairment had higher pain intensity, shorter duration of disease, were taking narcotics, had more impaired vision-related mental health scores, and worse social health scores. We found an association between objective cognitive impairment and subjective perception of impairment only when controlling for pain. We found no associations with depression and topiramate use. The mean composite cognitive Z score was no different in chronic migraineurs and patients with pseudotumor cerebri. CONCLUSIONS AND CLINICAL IMPLICATIONS: Most chronic migraineurs have normal cognitive profiles, but a large proportion of them do experience mild cognitive impairment, especially in multiple domains. The impairment seen in migraine is similar to that in pseudotumor cerebri syndrome, which has already been associated with mild cognitive impairment. Cognitively impaired migraineurs are different from non-impaired/less impaired migraineurs in several ways, which may be an important factor in influencing their migraine treatment.

Depression, anxiety and stress in Saudi migraine patients using DASS-21: local population-based cross-sectional survey.

Background: Psychiatric comorbidity is common among migraineurs, such as anxiety and depression. This type of comorbidity contributed to migraine chronicity, management efficacy, and increasing the risk for other comorbidities. This study designed to estimate the prevalence of depression, anxiety, and stress (DAS) symptoms among Saudi migraine patients using the validated instrument (DASS-21) and considering socio-demographic factors and individual differences that affect migraine progression and prognosis.Design/methods: Cross-sectional, self-administered, web-based-questionnaire distributed among Saudi Arabia general population. Only migraine patients with clinical diagnosis allowed to complete the survey.Results: A total of 247 migraine patients participated and they are predominantly females, with ages between 16 and 45 years, Saudi nationals, married, non-smokers but do not exercise regularly. About 73.3% met the abnormal score in anxiety on DASS-21, as well as 70.9% in depression and 72.3% in stress. Four statistically significant correlations with DAS were identified. Migraine patients who are smoking have a higher prevalence of depression and stress (p < 0.05). Those who do not exercise regularly have a higher prevalence only for depression (p = 0.03). A higher prevalence of all emotional states was found in patients with more than one co-morbidity and patients with a clinical diagnosis of depression and anxiety disorders (p < 0.02). The sensitivity of DASS-21 for depression and anxiety are 96.9% and 93.3%, respectively.Conclusions: Both smoking cessation and exercise to prevent migraine attacks deserve a clinical trial. A holistic approach is needed to decrease psychiatry-related disability and promote management outcomes in migraineurs. Using DASS-21 for migraine patients as a routine screening instrument is valuable to prevent psychiatric comorbidity.

Examining the correlation between salivary cytokine concentrations and CRP in people experiencing social-cognitive stress.

OBJECTIVES: The study aims to determine the relationship of migraine and chronic tension-type headache (TTHs) with alterations in the salivary markers of inflammation . METHODS: The prospective study involved 75 patients . The concentrations of inflammatory markers (CRP, IL-1 ß, and IL-6) in migraine and chronic TTH patients were determined in distinct time points: headache-free period (interictal period), during headache (ictal period), day after headache attack. The STAI-Y (State Trait Anxiety Inventory - Y) and BDI (Beck Depression Inventory) questionnaires were used to measure the level of anxiety and depression in the interictal and ictal periods. RESULTS: The interictal levels of CRP, IL1-ß, and IL-6 were significantly higher in headache groups compared to healthy controls (p < 0.001). Differences in the ictal concentrations were even stronger. Twenty-four hours after headache attack, patients with migraine and chronic TTH experienced a decrease in CRP, IL1-ß, and IL-6 levels; yet, those levels were still higher compared with the interictal ones. The repeated analysis of variance revealed no significant statistical differences in CRP, IL-ß, and IL-6 levels between the migraine and TTH groups over time (p > 0.05). Statistically higher levels of anxiety and depression were seen in unhealthy groups (p < 0.01). CONCLUSIONS: The relationship of CRP, IL1-ß, and IL-6 concentrations with migraine and chronic TTH has been established. No statistically significant differences were found in the dynamics between migraine and chronic TTH groups. There was a direct correlation of migraine and chronic TTH with anxiety and depression.

Preventive treatment can reverse cognitive impairment in chronic migraine.

OBJECTIVE: To study the impact of chronic migraine (CM) on the cognition and quality of life (QoL) of patients in the interictal period, and to analyse the degree of reversibility of any observed alterations following the use of preventive treatment. BACKGROUND: CM is a highly disabling disease, and migraineurs often have associated comorbidities, such as subjective memory problems, that are involved in the development of cognitive impairment. Our hypotheses are that patients suffering from chronic migraine experience objective cognitive alterations that are not only due to the pain that they suffer or their current emotional state. Furthermore, preventive treatment should be capable of reversing, or at least reducing, the impact of CM on the cognition and QoL of migraineurs. METHODS: The cognition and QoL of 50 control subjects and 46 patients with CM were assessed using a battery of tests, prior to the use of preventive treatment based on botulinum toxin or oral drugs and after 3 months of this treatment. RESULTS: Compared with controls, patients with CM had lower scores on the assessment of cognitive performance (Rey-Osterrieth Complex Figure test [ROCF] (p<0.05), Trail Making Test [TMT] B) (p < 0.05) and QoL (p < 0.05). Three months after the use of preventive treatment, improvement was observed in all cognitive parameters (p < 0.05) and QoL (p < 0.05), except the ROCF copy task (p = 0.79). No statistically significant differences were observed when these outcomes were compared based on treatment. CONCLUSIONS: This study confirms poor cognitive performance that is not explained by migraine pain itself, as it occurs in the interictal period, irrespective of the patient's emotional status. Our findings show that these effects are reversible in some cases with preventive treatment of CM, reaffirming the important impact of this condition on the QoL of these patients, and the need to establish preventive treatment guidelines.

A stated preference survey to explore patient preferences for novel preventive migraine treatments.

OBJECTIVE: The objective of this study was to explore patient preference for attributes of calcitonin gene-related peptide (CGRP) inhibitors for the preventive treatment of migraine and to describe differences in treatment preferences between patients. BACKGROUND: CGRP inhibitors are a novel class of migraine drugs specifically developed for the preventive treatment of migraine. Clinicians should understand patient preferences for CGRP inhibitors to inform and support prescribing choices. METHODS: Patients with migraine in the US and Germany were recruited to participate in an online discrete choice experiment (DCE) survey, which presented hypothetical treatment choices using five attributes: mode of administration, side effects, migraine frequency, migraine severity, and consistency of treatment effectiveness. Attribute selection was informed by a literature review and semi-structured patient interviews (n = 35), and evaluated using patient cognitive debriefing interviews (n = 5). RESULTS: Of 680 who consented to participate, 506 participants completed the survey and were included in the study (US = 257; Germany = 249). Overall, participants placed highest importance (preference weight, beta = 1.65, p < 0.001) on the treatment's ability to reduce the severity of migraine (mild vs. unchanged severity), followed by consistent treatment effectiveness (beta = 1.13, p < 0.001), and higher chance of reduced migraine frequency (beta = 1.00, p < 0.001). Participants preferred an oral tablet every other day (beta = 1.00, p < 0.001) over quarterly infusion, quarterly injections (p = 0.019), or monthly injection (p < 0.001). Preference for all treatment attributes were heterogeneous, and the subgroup analyses found that participants naïve to CGRP monoclonal antibody treatments had a stronger preference for oral therapy compared to those with such experience (p = 0.006). CONCLUSION: In this DCE assessing CGRP inhibitors attributes, the main driver of patient choice was treatment effectiveness, specifically reduced migraine severity, and consistent treatment effectiveness. Further, patients exhibited an overall preference for an oral tablet every other day over injectables. Patients' experience with previous treatments informs the value they place on treatment characteristics.

FEATURE OF GUT MICROBIOTA IN PATIENTS WITH MIGRAINE AND HEALTHY INDIVIDUALS.

The gut - brain axis plays a significant role in the pathophysiology of migraine. This interaction can be influenced by multiple factors, such as gut microbiota profiles. The aim of the study was to analyze the gut microbiome state in patients with migraine and healthy individuals, to assess possible correlations between the detected changes in patients with migraine and the frequency, intensity of headaches, their psycho-emotional state, and quality of life. In total, 112 patients-16.3% of men and 83.7% of women. Subjects were divided into 2 groups depending on the presence of migraine: the main - patients with chronic and episodic forms of migraine, the control - healthy individuals. The study of the intestinal microbiome was performed by chromato-mass spectrometry. The following scales were used: Visual Analogue Scale/VAS, Migraine Disability Assessment/MIDAS, Back Depression Inventory/BDI. In patients with migraine compared with healthy individuals, significant changes were noted in the quantitative composition of certain resident microorganisms including Alcaligenes spp (p=0.0061), Clostridium coccoides (p=0.0021), Clostridium propionicum (p=0.0287), Eggerthella lenta (p=0.0138), Pseudonocardia spp (p=0.0210), and Rhodococcus spp (p=0.0164). The number of microscopic fungi such as Candida spp (p=0.0079), Micromycetes spp (p=0.0011) and Micromycetes spp (p=0.0010) were increased in patients with migraine compared to the control group. In the main group, a negative correlation was found between the level of 16 Alcaligenes spp and the score on the BDI score, HARS score (respectively: r= -0.6226, p= 0.007; r= -0.509, p=0.03), the frequency of attacks (r=-0.4879, p=0.046) and the VAS score (r=-0.487, p=0.046). Significant negative correlation was found between elevated level of Clostridium coccoides and MIDAS score (r=-0.5123, p=0.03), BDI score (r=-0.54, p=0.025) in the patients with migraine. At the same time, in the main group a positive correlation was detected between Eggerthella lenta level of and VAS score (r=0.4830, p=0.049). In the main group negative correlations were found between slightly increased content of endotoxin in the main group, the BDI score, HARS score (respectively: r=-0.697, p=0.001; r=-0.557, p=0.02) the frequency of attacks (r=-0.547, p=0.023), on the VAS score (r= -0.531, p=0.028), as well as MIDAS score (r =-0.556, p=0.02). The revealed peculiarities of gut microbiome changes in patients with migraines need further clarification in order to identify the possible role of the gut microbiome in the pathogenesis, clinical picture, and therapy of migraine, and is a promising area of further scientific research.