Minimal important difference of the Migraine Disability Assessment (MIDAS): Longitudinal data from the DMKG Headache Registry.

BACKGROUND: The Migraine Disability Assessment (MIDAS) is widely used. However, there are limited data on how much a reduction in the MIDAS score indicates a change that matters to the patient. METHODS: Data from the DMKG (i.e. German Migraine and Headache Society) Headache Registry were used to determine the minimal important difference (MID) of the MIDAS, using the Patient Global Impression of Change (PGIC) as anchor and applying average change and receiver operating characteristic curve methods. RESULTS: In total, 1218 adult migraine patients (85.6% female, 40.2 ± 12.8 years, baseline MIDAS 44.2 ± 47.4, follow-up MIDAS 36.5 ± 45.3) were included. For patients with baseline MIDAS >20 (MIDAS grade IV, n = 757), different methods using PGIC "somewhat improved" as anchor yielded percent change MIDs of the MIDAS between -29.4% and -33.2%. For baseline MIDAS between 6 and 20 (grades II and III, n = 334), using PGIC "much improved" as anchor, difference change MIDs were between -3.5 and -4.5 points. CONCLUSIONS: Based on the above results, we estimated the MID of the MIDAS at -30% for patients with a baseline MIDAS >20, and at -4 points for those with a baseline MIDAS of 6-20, for a tertiary headache care population. TRIAL REGISTRATION: The DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

Relationship between Contingent Negative Variation and afterimage duration in migraine patients.

Background: Abnormalities in electrocortical parameters and persistence of afterimage after visual stimulation are known to occur in migraine patients. The results of studies on Contingent Negative Variation (CNV) and afterimage persistence in migraine patients suggest a link between these two phenomena and a connection to the pathomechanism of migraine. Objectives: To date, no studies have investigated both afterimage duration and CNV parameters in the same subjects. The aim of this study was to investigate the relationship between the early component of CNV (iCNV) and the duration of the afterimage in migraine patients. Methods: Sixty seven migraine patients from the headache center of the University of Rostock Medical Center were examined for iCNV amplitude, iCNV habituation and afterimage duration. The subjects also completed questionnaires developed for this study and the MIDAS (Migraine Disability Assessment) questionnaire. Results: Associations were found between iCNV amplitude and afterimage duration and between habituation capacity and afterimage duration. A deficit in habituation capacity correlated with a significantly prolonged afterimage duration. Increased iCNV amplitude and prolonged afterimage duration were also significantly correlated. Conclusion: Conclusions about the pathophysiology of migraine can be drawn from the results of this study. The results support the hypothesis of cortical hyperexcitability as a consequence of a low pre-activation level, which may be a possible contributory cause of migraine. Furthermore, they allow assessment of whether the afterimage examination, which is easier and quicker to perform than the CNV examination, can be used as a diagnostic tool or as a parameter to monitor the course of therapy in people with migraine.

How Individuals Shape Their Acoustic Environment: Implications for Hearing Aid Comparison in Ecological Momentary Assessment.

OBJECTIVES: When using ecological momentary assessment (EMA) to compare different hearing aid programs, it is usually assumed that for sufficiently long study durations similar situations will be experienced in both programs. However, conscious or subconscious adaptation of situations to one's hearing ability (e.g., asking a conversation partner to speak up, increasing TV volume)-which might be different across the time spent in different hearing aid programs-may challenge this assumption. In the present study, we investigated how test participants modify their acoustic environment and if these modifications depend on the hearing program. DESIGN: Twenty-nine experienced hearing aid users were provided with hearing aids containing two hearing programs differing in directionality and noise reduction (NR). The hearing programs called NR-on and NR-off changed each day automatically. Over the course of 3 weeks, participants were asked to answer a questionnaire every time they encountered an acoustic situation they modified or would have liked to modify to improve the listening situation. Objective data on sound pressure level and classification of the acoustic situation were collected from the hearing aids. At the beginning of the study participants recollected modifications of the acoustic environments they typically do when using their own hearing aids and reported on the frequency of this behavior. RESULTS: During the field trial, participants reported on average 2.3 situations per day that they modified or would have liked to modify. Modifications were usually performed quickly after the onset of the situation and significantly improved the pleasantness of the listening situation. While the number of the reported situations did not differ between the programs, modifications increasing the volume of the target signal and increasing the hearing aid volume were more frequent for the NR-on hearing program. Changes in the objective data at the time of the modification were consistent with the reported modifications. Further, the usage time as well as the distribution of the acoustic situations over the entire study period differed between the two hearing programs. CONCLUSIONS: The large improvement in pleasantness due to the modification might explain the generally positive ratings observed in EMA studies. Furthermore, the results found here suggest that caution is needed when comparing ratings of audiological attributes in EMA, because the different modification behavior across hearing programs may lead to an underestimation of hearing problems and reduced sensitivity when comparing two technologies.

Efficacy of cranial electrotherapy stimulation in patients with burning mouth syndrome: a randomized, controlled, double-blind pilot study.

Background: The Burning mouth syndrome (BMS) is a chronic pain syndrome characterized by a burning sensation in the oral mucous membranes. The etiology and pathophysiology of BMS is largely unexplained. To date, there is no evidence-based treatment strategy for BMS. Cranial electrical stimulation (CES) represents a non-invasive treatment option with a low side effect profile that is approved for the treatment of pain, depression, anxiety disorder and insomnia. It has shown efficacy in studies for chronic pain such as fibromyalgia and neuropathic pain after spinal cord injury. This study aimed to investigate the therapeutic effectiveness of CES in combination with local transcutaneous electrical nerve stimulation (TENS) as an adjunct therapy in patients with BMS compared to sham stimulation. Methods: This randomized, double-blind, sham-controlled pilot study enrolled 22 patients, aged 18 years and over, with the diagnosis of BMS meeting the ICHD-3 criteria from August 2020 to June 2021. The study duration was 4 weeks (28 days) per participant. After randomization, the active group participants (n = 11) received a 100 µA CES treatment for 60 min a day whereas the devices in the Sham group did not emit electricity. Simple linear regression was used to determine whether the interventions promoted significant differences in pain intensity. Results: The linear regression showed that the period of stimulation significantly predicted decrease in the intensity of pain in the active group [ß = -0.036; t(26) = -7.219; p < 0.001] as in the sham group [ß = -0.026; t(26) = -2.56; p < 0.017]. With the applied cutoff of 30% pain reduction within the stimulation period, both the active and sham groups had 36% responders (n = 4) (Fisher's exact test, p = 1.00). In both groups (active stimulation and sham group), a significant decrease in the intensity of pain, somatic symptoms and an improvement in sleep quality over the study period was observed. Subjects reported no adverse events during the study. Conclusion: Although CES is an easily applicable and safe therapeutic option for chronic facial pain, active stimulation was not superior to sham stimulation. Among other reasons, this could be due to the short double-blinded treatment period, duration of the daily stimulation session or the small sample size.

Auditory Spatial Bisection of Blind and Normally Sighted Individuals in Free Field and Virtual Acoustics.

Sound localization is an important ability in everyday life. This study investigates the influence of vision and presentation mode on auditory spatial bisection performance. Subjects were asked to identify the smaller perceived distance between three consecutive stimuli that were either presented via loudspeakers (free field) or via headphones after convolution with generic head-related impulse responses (binaural reproduction). Thirteen azimuthal sound incidence angles on a circular arc segment of ±24° at a radius of 3 m were included in three regions of space (front, rear, and laterally left). Twenty normally sighted (measured both sighted and blindfolded) and eight blind persons participated. Results showed no significant differences with respect to visual condition, but strong effects of sound direction and presentation mode. Psychometric functions were steepest in frontal space and indicated median spatial bisection thresholds of 11°-14°. Thresholds increased significantly in rear (11°-17°) and laterally left (20°-28°) space in free field. Individual pinna and torso cues, as available only in free field presentation, improved the performance of all participants compared to binaural reproduction. Especially in rear space, auditory spatial bisection thresholds were three to four times higher (i.e., poorer) using binaural reproduction than in free field. The results underline the importance of individual auditory spatial cues for spatial bisection, irrespective of access to vision, which indicates that vision may not be strictly necessary to calibrate allocentric spatial hearing.

[Interdisciplinary multimodal pain therapy in headache disorders]. / Interdisziplinäre multimodale Schmerztherapie bei Kopfschmerzerkrankungen.

Primary headaches are among the most common pain disorders. They include migraines (prevalence 15%), tension headaches (up to 80%), and others, including trigeminal autonomic headaches (about 0.2%). Migraine, in particular, leads to significant impairment of personal life and high societal costs. Therefore, the need for effective and sustainable therapeutic procedures is high. This article provides an overview of psychological procedures in headache therapy and critically summarizes the empirical evidence for the effectiveness of interdisciplinary multimodal pain therapy (IMST) consisting of psychotherapy and pharmacotherapy. It can be shown that psychoeducation, relaxation procedures, cognitive behavioral therapy, and biofeedback are psychological procedures from which headache patients can benefit. In the synopsis of multimodal approaches in the treatment of headache, consistently greater effects can be observed when both pharmacological treatment and psychotherapeutic procedures are used. This added value should be regularly taken into account in the treatment of headache disorders. This requires close cooperation between headache specialists and psychotherapists who specialize in the treatment of pain.

Resistant and refractory migraine: clinical presentation, pathophysiology, and management.

Migraine is a leading cause of disability worldwide. A minority of individuals with migraine develop resistant or refractory conditions characterised by ≥ 8 monthly days of debilitating headaches and inadequate response, intolerance, or contraindication to ≥3 or all preventive drug classes, respectively. Resistant and refractory migraine are emerging clinical definitions stemming from better knowledge of the pathophysiology of migraine and from the advent of migraine-specific preventive treatments. Resistant migraine mostly results from drug failures, while refractory migraine has complex and still unknown mechanisms that impair the efficacy of preventive treatments. Individuals with resistant migraine can be treated with migraine-specific preventive drugs. The management of refractory migraine is challenging and often unsuccessful, being based on combinations of different drugs and non-pharmacological treatment. Future research should aim to identify individuals at risk of developing treatment failures, prevent the condition, investigate the mechanisms of refractoriness to treatments, and find effective treatment strategies.

[Differential diagnostics of chronic eye pain from a neurological perspective-What can also lie behind it]. / Differenzialdiagnosen chronischer Augenschmerzen aus neurologischer Sicht ­ Was auch dahinterstecken kann.

Periorbital pain and pain in the eye may arise from nociceptive processes such as chronic ocular surface destruction and inflammation, from neuropathic processes or often from a combination of different mechanisms. An important differential diagnosis are primary headache disorders and other neurological diseases, for example of inflammatory origin, which trigger secondary pain. Chronic eye pain therefore requires interdisciplinary collaboration in the diagnostics and treatment.

Triptan non-response in specialized headache care: cross-sectional data from the DMKG Headache Registry.

BACKGROUND: Triptans are effective for many migraine patients, but some do not experience adequate efficacy and tolerability. The European Headache Federation (EHF) has proposed that patients with lack of efficacy and/or tolerability of ≥ 2 triptans ('triptan resistance') could be considered eligible for treatment with the novel medications from the ditan and gepant groups. There is little data on the frequency of 'triptan resistance'. METHODS: We used patient self-report data from the German Migraine and Headache Society (DMKG) Headache Registry to assess triptan response and triptan efficacy and/or tolerability failure. RESULTS: A total of 2284 adult migraine patients (females: 85.4%, age: 39.4 ± 12.8 years) were included. 42.5% (n = 970) had failed ≥ 1 triptan, 13.1% (n = 300) had failed ≥ 2 triptans (meeting the EHF definition of 'triptan resistance'), and 3.9% (n = 88) had failed ≥ 3 triptans. Compared to triptan responders (current use, no failure, n = 597), triptan non-responders had significantly more severe migraine (higher frequency (p < 0.001), intensity (p < 0.05), and disability (p < 0.001)), that further increased with the level of triptan failure. Responders rates were highest for nasal and oral zolmitriptan, oral eletriptan and subcutaneous sumatriptan. CONCLUSION: In the present setting (specialized headache care in Germany), 13.1% of the patients had failed ≥ 2 triptans. Triptan failure was associated with increased migraine severity and disability, emphasizing the importance of establishing an effective and tolerable acute migraine medication. Acute treatment optimization might include switching to one of the triptans with the highest responder rates and/or to a different acute medication class. TRIAL REGISTRATION: The DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

Perception of typical migraine images on the internet: Comparison between a metropolis and a smaller rural city in Germany.

The medial portrayal of migraine is often stereotypical and inaccurate but reflects how society perceives migraine. The discrepancy between others' views and the reality of affected individuals may negatively affect access to treatment and the disease course of patients with migraine. This study aimed to investigate whether images presented in the media as typical migraine attacks are perceived as realistic and representative by migraine patients in Rostock, a smaller town in rural Germany, and compare the results to those from Berlin, a large metropolis. We performed an online survey in Rostock. Migraine patients were shown ten images of migraine attacks, which were among the most downloaded stock pictures on the internet under the search term "migraine". They rated on a scale of 0-100 to what extent the pictures were realistic for migraine attacks (realism score), representative of their own migraine (representation score), or the society's view of migraine (society score). In addition, we compared our results with a recently published study from the metropolitan region of Berlin. A total of 174 migraine patients completed our survey. Mean (SD) realism, representation, and society scores were 59.9 (17.5), 56.7 (18.3), and 58.4 (17.1) respectively. Images of older patients were perceived as significantly more realistic and representative than those of younger patients (P < .001). Patients in Rostock (rural region) rated the images as significantly more realistic and representative than survey participants in Berlin (metropolis). Migraine patients in a rural region found typical migraine images only moderately realistic and representative but to a higher degree than their counterparts from a metropolis.

What do patients' efficacy and tolerability ratings of acute migraine medication tell us? Cross-sectional data from the DMKG Headache Registry.

BACKGROUND: Most migraine patients need an effective acute medication. Real-world data can provide important information on the performance of acute migraine medication in clinical practice. METHODS: We used data from the German Migraine and Headache Society Headache Registry, where patients rate efficacy and tolerability of and satisfaction with each of their acute headache medications. RESULTS: A total of 1756 adult migraine patients (females: 85%, age: 39.5 ± 12.8 years, headache days per month: 13.5 ± 8.1) were included. Of these, 93% used acute medication, most frequently triptans (59.3%) and/or non-opioid analgesics (56.4%), and 58.5% rated efficacy as good or very good. This was more frequent for triptans (75.4%) than for non-opioid analgesics (43.6%, p < 0.001). Among non-opioid analgesics, naproxen was rated most effective (61.9% very good or good, p < 0.001 compared to ibuprofen, acetylsalicylic acid and paracetamol). Patient-rated efficacy significantly declined with higher headache frequencies (p < 0.001), and this effect remained significant after omitting patients overusing acute medication. CONCLUSION: In the present population recruited at specialized headache centers, patients rated triptans as more effective than non-opioid analgesics, naproxen as more effective than ibuprofen, and acute medication efficacy decreased with increasing headache frequency.Trial registration: The German Migraine and Headache Society Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

Headache impact and socioeconomic status: findings from a study of the German Migraine and Headache Society (DMKG).

BACKGOUND: Headache disorders are not only among the most prevalent, they are also among the most disabling disorders worldwide. This paper investigates the association between headache impact on daily life and the socioeconomic status (SES) of headache sufferers. METHODS: Data stem from a random general population sample in Germany. Respondents who reported having headache for at least a year and were aged ≥ 18 years were included in the study. A standardized questionnaire addressing headache and headache treatment was filled in during the face-to-face survey. The impact of headache on daily life was measured using the German version of the Headache Impact Test (HIT-6). RESULTS: Higher headache impact was found in low and medium SES compared to high SES. After adjustment for sociodemographics, headache-related factors (analgesic use, headache duration, headache frequency, migraine diagnosis), depressive symptoms, physical inactivity and obesity, an increased odds ratio of having higher headache impact in low SES compared to high SES was found: OR = 1.83, 95% CI [1.43, 2.23], p = .014. When the interactions "SES*obesity", "SES*depressive symptoms", and "SES*physical inactivity" were added, the results showed a significant interaction effect of "SES*obesity". Obese persons with low SES were 3.64 times more likely to have higher headache impact than non-obese persons with low SES. No significant differences between obese and non-obese persons were found in the medium and high SES groups. CONCLUSIONS: SES is an important factor that should not be neglected in headache awareness campaigns and headache treatment. Longitudinal studies are needed in the future to investigate whether lifestyle interventions, such as weight reduction, can help to reduce headache impact in people in lower SES.

Medication adherence in patients with cluster headache and migraine: an online survey.

To examine factors for adherent and non-adherent behavior in patients with cluster headache and migraine. Adults with cluster headache or migraine were included in this anonymous online survey using a questionnaire accessed via homepages of headache support groups. Medication adherence in preventive treatment was measured with the Medication Adherence Report Scale (MARS-D). Factors for non-adherent behavior were examined (subjective socioeconomic status, psychological comorbidities, self-efficacy, coping, side effects, expectations of treatment, information on medical treatment, and trust in the physician/treatment concept). 200 participants (n = 58 with cluster headache, n = 142 with migraine) were included. The rate of medication adherence in preventive treatment was 32.8% for participants with cluster headache and 20.4% for migraine. The most common reasons for low adherence in participants with cluster headache were altering the prescribed medication dose (34%) or taking less than instructed (14%), which was mostly due to insufficient benefit from the medication or side effects. Positive expectations of medical treatment (p ≤ 0.05) correlated significantly with adherent behavior in cluster headache. Furthermore, the adherence-promoting factors coping and self-efficacy were more pronounced in patients with cluster headache than in those with migraine (p < 0.05). This study is the first to comprehensively investigate medication adherence and factors influencing adherent/non-adherent behavior in patients with cluster headache. Patients with cluster headache had similar adherence levels to patients with migraine, but had higher resources of adherence-promoting factors.

Middle Ear Implant Usage Restores Subjective Listening Effort toward Normal in Complex Acoustic Scenes.

INTRODUCTION: The amount of listening effort needed to understand speech in every-day life is an important outcome measure of the effectiveness of a hearing device. The main goal of this study was to assess subjective listening effort in patients implanted with an active middle ear implant Vibrant Soundbridge (VSB) with and without using their speech processor in complex acoustic scenarios. METHODS: Ten VSB users were measured using the adaptive categorical listening effort scaling (ACALES) method in four different acoustic scenarios, realized using a multichannel loudspeaker array. The four acoustic scenarios included both spatially simple and complex speech and noise arrangements that realistically simulated challenging every-day listening situations. Signal-to-noise ratios (SNRs) were adaptively varied during the measurement. Twelve normal-hearing (NH) listeners performed the same experiment as a control group. RESULTS: Listening effort was significantly reduced in all tested acoustic scenarios when participants used their VSB. When using the VSB, SNRs corresponding to mild-to-moderate listening effort were found not to be statistically different from SNRs found in the NH control group. SNRs corresponding to extreme listening effort of VSB users approached NH values, indicating partial restoration of listening effort. DISCUSSION AND CONCLUSIONS: Usage of the middle ear implant VSB was found to restore subjective listening effort to normal at high SNRs completely, and at lower SNRs partially. The remaining gap at low SNRs may be due to lower effectiveness of signal processing at high noise levels or due to the microphone location effect.

Hearing rehabilitation and microbial shift after middle ear surgery with Vibrant Soundbridge in patients with chronic otitis media.

INTRODUCTION: Patients with otitis media (OM) encounter significant functional hearing impairment with conductive, or a combined hearing loss and long-term sequelae involving impaired speech/language development in children, reduced academic achievement and irreversible disorders of middle and inner ear requiring a long time therapy and/or multiple surgeries. In its persistent chronic form, Otitis media (COM) can often only be treated by undergoing ear surgery for hearing restoration. The persistent inflammatory reaction plays a major role, often caused by multi-resistant pathogens in the ear. Herein, we present outcomes of patients implanted with currently the only FDA approved active Middle Ear Implant Vibrant Soundbridge (VSB), suffering from persistent COM. METHODS: The study enrolled 42 patients, treated by performing middle ear (ME) surgery to different extents and implanted with the VSB to various structures in the ME. Included were 17 children and 25 adults that had recurrent and/or persisting OM and significant hearing loss. Preoperative and postoperative patients' audiometric data were evaluated and the benefit with VSB assessed using the Glasgow Benefit Inventory for adults and pediatric cohorts. The microbial spectrum of pathogens was assessed before and after surgery, exploring the colonization of the otopathogens, as well as the intestinal microbiome from individually burdened patients. RESULTS: The mean functional gain is 29.7 dB HL (range from 10 to 56.2 dB HL) with a significant improvement in speech intelligibility in quiet. Following VSB implantation, no significant differences in coupling were observed at low complication rates. Postoperatively patients showed significantly increased benefit with VSB compared to the untreated situation, including less otorrhea, pain, medical visits, and medication intake, with no recurrent OM and significant bacterial shift in otopathogens. The analysis of the intestinal microbiome displayed a high abundance of bacterial strains that might be linked to chronic and persistent inflammation. CONCLUSIONS: Functional ear surgery including rehabilitation with a VSB in patients suffering from COM present to be safe and effective. The successful acceptance accompanied by the improved audiological performance resulted in significant benefit with VSB, with a shift in the ear pathogens and altered microbiome and thus is a great opportunity to be treated.

Spatial speech-in-noise performance in simulated single-sided deaf and bimodal cochlear implant users in comparison with real patients.

OBJECTIVE: Speech reception thresholds (SRTs) in spatial scenarios were measured in simulated cochlear implant (CI) listeners with either contralateral normal hearing, or aided hearing impairment (bimodal), and compared to SRTs of real patients, who were measured using the exact same paradigm, to assess goodness of simulation. DESIGN: CI listening was simulated using a vocoder incorporating actual CI signal processing and physiologic details of electric stimulation on one side. Unprocessed signals or simulation of aided moderate or profound hearing impairment was used contralaterally. Three spatial speech-in-noise scenarios were tested using virtual acoustics to assess spatial release from masking (SRM) and combined benefit. STUDY SAMPLE: Eleven normal-hearing listeners participated in the experiment. RESULTS: For contralateral normal and aided moderately impaired hearing, bilaterally assessed SRTs were not statistically different from unilateral SRTs of the better ear, indicating "better-ear-listening". Combined benefit was only found for contralateral profound impaired hearing. As in patients, SRM was highest for contralateral normal hearing and decreased systematically with more severe simulated impairment. Comparison to actual patients showed good reproduction of SRTs, SRM, and better-ear-listening. CONCLUSIONS: The simulations reproduced better-ear-listening as in patients and suggest that combined benefit in spatial scenes predominantly occurs when both ears show poor speech-in-noise performance.