Real-life experiences with galcanezumab and predictors for treatment response in Turkey.

BACKGROUND: The complexity of clinical practice extends far beyond the controlled settings of trials, and there is a need for real-world studies aimed at identifying which patients will respond to anti-CGRP monoclonal antibodies in different countries. This study aimed to investigate the efficacy and safety of galcanezumab in treating migraine in a real-life setting in Turkey, as well as identify predictors of treatment response. METHODS: A total of 476 patients who diagnosed with migraine according to ICHD-3 criteria and treated with galcanezumab by headache specialists were voluntarily participated in this cross-sectional study. Galcanezumab is indicated for the prevention of migraine in adults who have at least 4 monthly migraine days in Turkey. All patients filled out a survey on Google Form that comprised 54 questions, addressing various aspects such as demographics, migraine characteristics, previous use of acute symptomatic medication, failures with preventive drug classes, comorbidities, most bothersome symptoms, as well as the interictal burden of migraine. RESULTS: Among the participants, 89.3% reported that galcanezumab treatment was beneficial for them. A decrease in the frequency (80.0%), severity (85.7%), and acute medication usage for migraine attacks (71.4%) was reported with galcanezumab treatment. An adverse effect related to galcanezumab was reported in 16.3% of cases, but no serious adverse reactions were observed. Remarkably, 14.3% of participants reported no longer experiencing any headaches, and 18.9% did not require any acute treatment while receiving galcanezumab treatment. A logistic regression model showed that male gender, lack of ictal nausea, and previous failure of more than 2 prophylactic agents may predict the non-responders. CONCLUSIONS: The first large series from Turkey showed that galcanezumab treatment is safe and effective in most of the patients diagnosed with migraine by headache experts in the real-life setting. Patients reported a significant decrease in both ictal and interictal burden of migraine and expressed satisfaction with this treatment.

Intraoperative recording of laryngeal adductor reflex and cortical motor evoked potentials during jugular foramen schwannoma surgery: a case report and literature review.

PURPOSE: Schwannoma, a tumor originating from the peripheral nervous system, may arise from the vagus nerve, although it is not very often. Injury of the vagus nerve by surgical attempts may have consequences that will seriously affect the patient's quality of life. In recent years, continuous monitoring of the laryngeal adductor reflex (LAR) has become a promising methodology for evaluating vagus nerve function intraoperatively. We refer to our experience changing our surgical strategy due to concurrent deterioration in LAR and CoMEPs intraoperatively. We also provide a literature review and summarize the current knowledge of this technique. METHODS: The LAR was elicited and recorded by an electromyographic endotracheal tube in a 36-year-old man diagnosed with vagal nerve schwannoma. Subdermal needle electrodes were placed in both cricothyroid (CTHY) muscles for corticobulbar motor evoked potentials (CoMEPs) recording. RESULTS: Recordings of ipsilateral LAR and CTHY CoMEPs were obtained despite preoperative ipsilateral cord vocalis weakness. The surgical strategy was altered after the simultaneous decrease of CTHY CoMEPs and LAR amplitudes, and the surgery was completed with subtotal resection. No additional neurological deficit was observed in the patient except dysphonia, which resolved within a few weeks after the surgery. CONCLUSIONS: We conclude that LAR with vagal nerve CoMEPs are two complementary methods and provide reliable information about the functional status of the vagus nerve during surgery.

The role of metacognition, negative automatic thoughts and emotions in migraine-related disability among adult migraine patients.

This cross-sectional study investigates the relationship between problematic metacognitions, negative cognitive content and emotional distress, and migraine-related disability among adult migraine patients. The migraine group consisted of 74 patients. Forty-seven healthy volunteers with similar sociodemographic characteristics were selected as the comparison group. Sociodemographic form, Migraine Disability Assessment Scale, Depression Anxiety Stress Scale, Automatic Thought Questionnaire, and Metacognition Questionnaire-30 were administered. Our results showed that higher depression, anxiety, stress levels, and negative automatic thoughts are significantly associated with more significant migraine disability. Our data also showed that high levels of depression and increased headache frequency predict migraine-related severe disability. We found that the frequency of headaches over three months and positive beliefs about worry significantly predicted the presence of chronicity in migraine. Our findings may help determine different approaches such as cognitive behavioral therapy and relaxation techniques in treating migraine.

The relation of sexual function to migraine-related disability, depression and anxiety in patients with migraine.

BACKGROUND: Depression and anxiety are two phenomena that affect quality of life as well as sexual function. Depression and anxiety levels are reported to be high in migraine sufferers. We aimed to understand whether sexual function in women with migraine was associated to migraine-related disability and frequency of migraine attacks, and whether this relationship was modulated by depressive and anxiety symptoms. METHODS: As migraine is more commonly seen in females, a total of 50 women with migraine were included. The diagnosis of migraine with or without aura was confirmed by two specialists in Neurology, according to the second edition of International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) in 2004. Migraine disability assessment scale score, female sexual function index scores, Beck depression inventory score and Beck anxiety inventory scores. RESULTS: Mean MIDAS score was 19.3 ± 12.8, and mean number of migraine attacks per month were 4.3 ± 2.7. Mean Female Sexual Function Index score was 20.9 ± 5.9 and 90% of patients had sexual dysfunction. Sexual dysfunction was not related to MIDAS score or frequency and severity of attacks. No relationship between sexual function and anxiety was found, whereas severity of depressive symptoms was closely related to sexual function. Depressive symptoms affected all dimensions of sexual function, except for pain. CONCLUSION: Sexual dysfunction seemed to be very common in our patients with migraine, while not related to migraine related disability, frequency of attacks and migraine severity or anxiety. The most important factor that predicted sexual function was depression, which was also independent of disease severity and migraine related disability. While future larger scale studies are needed to clarify the exact relationship, depressive and sexual problems should be properly addressed in all patients with migraine, regardless of disease severity or disability.

The effectiveness and predictors influencing the outcome of onabotulinumtoxinA treatment in chronic migraine: understanding from diverse patient profiles in a single session.

Objective: This real-world study aimed to investigate how onabotulinumtoxinA affects the outcome of migraine, along with accompanying anxiety, depression, and bruxism among a group of patients with chronic migraine (CM) and define predictors of good response. Methods: Patients diagnosed with CM who received onabotulinumtoxinA were included in this single-center, real-world retrospective cohort study. Monthly headache days (MHDs), monthly migraine days (MMDs), headache intensity (numeric rating scale-NRS) and headache characteristics were evaluated at baseline and 12 weeks post-treatment. Patient-reported outcome measures (PROMs) included Migraine Disability Assessment Scale (MIDAS), Headache Impact Test-6 (HIT-6) scores, 12-item Allodynia Symptom Checklist (ASC-12), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI). Response to onabotulinumtoxinA (% reduction in MHDs) and treatment-related adverse events (TRAEs) were also evaluated. OnabotulinumA was applied to the masseter muscles in patients complaining of bruxism. Results: A total of 72 patients (mean ± SD age: 36.3 ± 8.5 years; 91.7% were female) diagnosed with CM were included. OnabotulinumtoxinA revealed significant decrease in median (IQR) MHDs [from 20(15-25) at baseline to 6(4-10), p < 0.001], MMDs [from 9(6-12) to 3(1-6), p < 0.001] and NRS [from 9(8-10) to 7(6-8), p < 0.001], and the MIDAS [from 54(30-81) to 16(7-24), p < 0.001], HIT-6 [from 67(65-69) to 58(54-64), p < 0.001], ASC-12 [from 6(1.5-9) to 2(0-9), p = 0.002], BAI [from 12(6.5-19) to 9(3-17), p < 0.001] and BDI [from 11(6.5-17) to 3(2-7) p < 0.001] scores at 12 weeks post-treatment. Patients complaining of bruxism received onabotulinumtoxinA injections in the first n = 27 (37.5%) and 12. week post-treatment n = 19 (70.4%) periods. Overall, 70.8% of patients responded (≥50% reduction in MHDs), while 29.2% did not (<50% reduction). Both groups showed similar characteristics in demographics, migraine history, baseline PROMs scores, comorbidities, and prior treatments. Conclusion: OnabotulinumtoxinA is an effective treatment option that rapidly improves migraine outcomes, disability, and impact while also alleviating comorbid depression and/or anxiety. This study's noteworthy finding is that onabotulinumtoxinA is effective in a majority of CM patients, irrespective of their prior treatment history, migraine characteristics, or concurrent comorbidities. Furthermore, we identified no specific predictors for a favorable response to onabotulinumtoxinA. Applying onabotulinumtoxinA to the masseter muscles can relieve discomfort associated with concurrent bruxism; however, it does not impact migraine outcomes.

Effectiveness of galcanezumab on sleep quality, migraine outcome, and multidimensional patient-reported outcome measures: a real-world experience in Turkish patients with episodic and chronic migraine.

Introduction: This real-world study aimed to investigate the impact of galcanezumab on sleep quality, migraine outcome and multidimensional patient-reported outcomes measures (PROMs) in patients with episodic migraine (EM) and chronic migraine (CM). Methods: Fifty-four patients with episodic migraine (n = 24) or chronic migraine (n = 30) received a 3-month series of galcanezumab injections and were evaluated for sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI), as well as migraine outcomes such as monthly headache days (MHDs), monthly migraine days (MMDs), and headache severity. Patient-reported outcome measures (PROMs) such as the Migraine Disability Assessment Scale (MIDAS), Headache Impact Test-6 (HIT-6), SF-36 Health-related Quality of Life (HRQoL), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI) were additionally included in the assessment. Results: The percentage of patients with poor sleep quality (total PSQI scores ≥ 5) was 72.7% at baseline, decreasing to 57.5% and 56.2% at the 1st and 2nd months, respectively. By the 3rd month of galcanezumab injections, significant improvement was observed in the sleep disturbances domain in the overall study population (p = 0.016), and in subgroups of patients with low anxiety levels (p = 0.016) and none/minimal depression (p = 0.035) at baseline. Patients with sleep disorder at baseline exhibited marked improvements in total PSQI scores (p = 0.027) and in the subjective sleep quality (p = 0.034) and daytime dysfunction (p = 0.013) domains, by the 3rd month. Over the 1st, 2nd, and 3rd months, there were significant improvements in MHDs (p < 0.001), MMDs (p < 0.001), HIT-6 scores (p < 0.001 for each), BAI scores (p < 0.001 for each), BDI scores (p ranged from 0.048 to <0.001), and HRQoL scores (p ranged from 0.012 to <0.001). Conclusion: Galcanezumab demonstrates notable benefits in improving sleep quality, along with a comorbidity-based and domain-specific effect on sleep parameters, which involved sleep disturbances domain in patients without depression or anxiety at baseline but the total PSQI scores, subjective sleep quality and daytime dysfunction in those with sleep disorder at baseline. The treatment also facilitates rapid-onset enhancements in migraine outcomes as well as various PROMs.

Cluster Analysis Revealed Two Hidden Phenotypes of Cluster Headache.

Objective: To investigate the possible subgroups of patients with Cluster Headache (CH) by using K-means cluster analysis. Methods: A total of 209 individuals (mean (SD) age: 39.8 (11.3) years), diagnosed with CH by headache experts, participated in this cross-sectional multi-center study. All patients completed a semi-structured survey either face to face, preferably, or through phone interviews with a physician. The survey was composed of questions that addressed sociodemographic characteristics as well as detailed clinical features and treatment experiences. Results: Cluster analysis revealed two subgroups. Cluster one patients (n = 81) had younger age at diagnosis (31.04 (9.68) vs. 35.05 (11.02) years; p = 0.009), a higher number of autonomic symptoms (3.28 (1.16) vs. 1.99(0.95); p < 0.001), and showed a better response to triptans (50.00% vs. 28.00; p < 0.001) during attacks, compared with the cluster two subgroup (n = 122). Cluster two patients had higher rates of current smoking (76.0 vs. 33.0%; p=0.002), higher rates of smoking at diagnosis (78.0 vs. 32.0%; p=0.006), higher rates of parental smoking/tobacco exposure during childhood (72.0 vs. 33.0%; p = 0.010), longer duration of attacks with (44.21 (34.44) min. vs. 34.51 (24.97) min; p=0.005) and without (97.50 (63.58) min. vs. (83.95 (49.07) min; p = 0.035) treatment and higher rates of emergency department visits in the last year (81.0 vs. 26.0%; p< 0.001). Conclusions: Cluster one and cluster two patients had different phenotypic features, possibly indicating different underlying genetic mechanisms. The cluster 1 phenotype may suggest a genetic or biology-based etiology, whereas the cluster two phenotype may be related to epigenetic mechanisms. Toxic exposure to cigarettes, either personally or secondarily, seems to be an important factor in the cluster two subgroup, inducing drug resistance and longer attacks. We need more studies to elaborate the causal relationship and the missing links of neurobiological pathways of cigarette smoking regarding the identified distinct phenotypic classes of patients with CH.

Relationship between MIDAS, depression, anxiety and alexithymia in migraine patients.

The co-existence of psychiatric comorbidities with migraine is well known; however, the relationship between alexithymia and migraine has not been persuasively shown yet. The aim of the study was to assess the relationships between migraine-related disability, depression, anxiety and alexithymia. One hundred and forty-five migraine patients (33.18 ± 8.6; 111 females, 34 males), and 50 control subjects (29.06 ± 7.6; 34 females, 16 males) were prospectively enrolled for the study. The participants completed a demographic data form and Migraine Disability Assessment Scale, Beck Depression Inventory, Beck Anxiety Inventory and Toronto Alexithymia Score-20 (TAS-20). All migraine patients were more depressive (p = 0.01) and anxious (p = 0.001) than the healthy subjects. TAS-20 scores of the migraine sufferers and the control group did not indicate alexithymia. The migraine-related disability of all migraine patients was severe (27.84 ± 29.22). Depression and anxiety scores in the migraine patients were highly correlated with each other and TAS-20 (r = 0.485, p = 0.001) and all its subscales in turn: difficulty in identifying (r = 0.435, p < 0.001) and describing feelings (r = 0.451, p = 0.001) and externally oriented thinking (r = 0.302, p = 0.001). Moreover, logistic regression analysis revealed that depression and anxiety predicted alexithymia. Our findings showed a complex relationship between migraine, depression, anxiety and alexithymia. On the other hand, alexithymia apparently was not directly connected to migraine, but its presence could be predicted in migraine patients because of co-morbid depression and anxiety.

A single-center retrospective study of onabotulinumtoxinA for treatment of 245 chronic migraine patients: survey results of a real-world experience.

Preventive treatment in migraine is associated with poor adherence and persistence. In this observational study, our first aim was to evaluate the perceived effectiveness of onabotulinumtoxinA based on our chronic migraine (CM) patients' treatment experience. The second purpose of this study was to determine the compliance with onabotulinumtoxinA treatment in our cohort. Third, we assessed the reasons for withdrawal from treatment in our CM patients. A total of 245 consecutive patients with CM (40.43 ± 10.15 years; 214 females, 31 males) were treated with at least one onabotulinumtoxinA. Data were collected by a standardized interview over the telephone. One-hundred and eighty patients were willing to answer questions about: (1) perceived effectiveness of onabotulinumtoxinA based on their treatment experience; (2) the current continuity of the treatment; (3) their current migraine-related disability; and (4) their current medication usage. The mean number of onabotulinumtoxinA cycles of all patients and the participants were 2.58 and 2.90, respectively. Of the 180 participants, 149 patients (82.8%) thought that onabotulinumtoxinA was effective in controlling their headaches. The mean score for perceived effectiveness of onabotulinumtoxinA treatment given by the participants was as 6.94 ± 2.4 (on a scale from 0 to 10). Of the 245 treated subjects, 31 (12.6%) were treated for 12 months. Compliance rates with onabotulinumtoxinA were very low in our population. However, even CM patients who did not complete five cycles of the treatment showed marked improvement of their current migraine-related disability and reduction of their medication intake as compared to baseline.

Pain levels of examined muscles and gender differences in pain during electromyography.

OBJECTIVES: The aim of this study was to evaluate the pain level of each muscle during an EMG study and also search for any association between the pain levels and gender. METHODS: Two hundred and twenty-seven subjects (166 females and 111 males) participated in the present study. Numeric analogue scale (NAS) was obtained from the patients after needle EMG for each muscle. RESULTS: In total, 1242 muscles were examined. The highest pain levels among examined muscles were found on Abductor Pollicis Brevis (APB) (5.8 ± 2.6), First Dorsal Interosseous (4.2 ± 2.6) and Vastus Lateralis (4.0 ± 2.6). NAS levels of the female patients (4.3 ± 2.7) were apparently higher than those of the male patients (2.8 ± 2.3) (p<0.01). CONCLUSION: First Dorsal Interosseous muscle was found less painful than APB muscle for the patients. Our study displayed greater pain sensitivity among females compared with males during the needle EMG; however, the pain levels of examined muscles were not higher than moderate for both genders.

Expected and Experienced Pain Levels in Electromyography.

INTRODUCTION: The aim of the present study was to assess pain using a visual analogue scale (VAS) in patients awaiting an EMG procedure (i.e., expected VAS) and after an EMG procedure (i.e., experienced VAS). METHODS: Expected and experienced pain in response to nerve conduction studies (NCS) and needle EMG were assessed in 108 patients (61 females, 47 males; mean age 43.2±11.6) using a VAS. RESULTS: No significant correlations were noted between the expected or the experienced VAS in response to EMG and demographic features of the patients. The expected VAS was significantly higher than the experienced VAS in response to needle EMG (p=0.005). The highest VAS level was noted in the expected VAS in response to needle EMG (4.7±2.2). The lowest VAS level was noted in the experienced VAS in response to NCS (3.6±2.5). CONCLUSION: The present study demonstrated that neither the expected nor the experienced pain associated with EMG exceeded a moderate level. Interestingly, we found that expected pain levels in response to needle EMG were significantly higher than experienced pain levels. Therefore, it may be possible to increase compliance if patients are provided with this information before undergoing electrophysiological procedures.

Botulinum Toxin in Migraine Treatment.

Since botulinum toxin might have a therapeutic effect on pain, many studies investigating the efficiency of botulinum toxin in headache treatment have been done. The most satisfying results were achieved by botulinum toxin type A (BoNT/A) in the treatment of chronic migraine. In this paper, we reviewed the clinical effectiveness of BoNT/A in migraine and included our clinical experience. In our ongoing pilot study, where we have repeated BoNT/A injections every 12 weeks, The difference in the Migraine Disability Assessment (MIDAS) scores between the first and the second injections was 61.1%; and between the first and the 3rd injections was found to be 65.72%.