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).

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.

[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.

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).

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.

[Consensus statement of the migraine and headache societies (DMKG, ÖKSG, and SKG) on the duration of pharmacological migraine prophylaxis]. / Konsensusstatement der Migräne- und Kopfschmerzgesellschaften (DMKG, ÖKSG & SKG) zur Therapiedauer der medikamentösen Migräneprophylaxe.

Migraine is the most common neurological disorder and can be associated with a high degree of disability. In addition to non-pharmacological approaches to reduce migraine frequency, pharmacological migraine preventatives are available. Evidence-based guidelines from the German Migraine and Headache Society (DMKG), and German Society for Neurology (DGN), Austrian Headache Society (ÖKSG), and Swiss Headache Society (SKG) are available for indication and application. For therapy-relevant questions such as the duration of a pharmacological migraine prevention, no conclusions can be drawn from currently available study data. The aim of this review is to present a therapy consensus statement that integrates the current data situation and, where data are lacking, expert opinions. The resulting current recommendations on the duration of therapy for pharmacological migraine prophylaxis are shown here.

[Consensus statement of the migraine and headache societies (DMKG, ÖKSG, and SKG) on the duration of pharmacological migraine prophylaxis]. / Konsensusstatement der Migräne- und Kopfschmerzgesellschaften (DMKG, ÖKSG & SKG) zur Therapiedauer der medikamentösen Migräneprophylaxe.

Migraine is the most common neurological disorder and can be associated with a high degree of disability. In addition to non-pharmacological approaches to reduce migraine frequency, pharmacological migraine preventatives are available. Evidence-based guidelines from the German Migraine and Headache Society (DMKG), and German Society for Neurology (DGN), Austrian Headache Society (ÖKSG), and Swiss Headache Society (SKG) are available for indication and application. For therapy-relevant questions such as the duration of a pharmacological migraine prevention, no conclusions can be drawn from currently available study data. The aim of this review is to present a therapy consensus statement that integrates the current data situation and, where data are lacking, expert opinions. The resulting current recommendations on the duration of therapy for pharmacological migraine prophylaxis are shown here.

[Influence of directional microphones on listening effort in middle ear implant users]. / Einfluss von Richtmikrofonie auf die Höranstrengung bei Mittelohrimplantatträgern.

BACKGROUND AND OBJECTIVE: Besides speech intelligibility, subjective listening effort is an important outcome for the success of hearing devices and their signal processing. The aim of the present study was to determine subjective listening effort for speech in a noisy background in patients with the active middle ear implant Vibrant Soundbridge (VSB) for omnidirectional and directional microphone settings, with and without occlusion of the contralateral ear. MATERIAL AND METHODS: A total of 15 patients using a VSB were measured using the adaptive categorical listening effort scaling (ACALES) method in a ring of loudspeakers placed in an anechoic room. Different background noises from different directions and simultaneously presented sentences from the Oldenburg sentence test were combined in four different realistic acoustic scenes. RESULTS: The directional microphone program reduced median subjective listening effort only numerically compared to the omnidirectional microphone program in acoustic scenarios with diffuse noise and with low signal-to-noise ratios; however, this difference failed to reach statistical significance. When occluding the ear contralateral to the VSB, all investigated listening effort categories were measured at significantly higher signal-to-noise ratios than with access to both ears. CONCLUSION: Due to missing statistical significance in reduction of listening effort, this study delivered no recommendation for or against usage of the directional microphone program; however, reduced listening effort was shown for binaural listening in comparison to monaural listening. Therefore, patients should be encouraged to always listen with both ears for best results.

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.

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).

Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies.

BACKGROUND: Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, has demonstrated efficacy for preventive treatment of episodic and chronic migraine. Since calcitonin gene-related peptide is expressed within the cardio- and cerebrovascular system and may have cardioprotective effects, it is critical to understand the cardio- and cerebrovascular safety of fremanezumab. METHODS: This was a pooled analysis of three randomized, double-blind, placebo-controlled, phase 3, 12-week trials in which patients with episodic migraine or chronic migraine received quarterly fremanezumab, monthly fremanezumab, or placebo. Incidences of overall and serious adverse events were analyzed. Cardio- and cerebrovascular adverse events (CVAEs) were analyzed in subgroups stratified by cardio- and cerebrovascular medical history, cardiovascular risk factors (CVRFs), and use of cardio- and cerebrovascular medications or triptans. RESULTS: Two thousand, eight hundred and forty-two patients were included in the study. Overall (58-65%) and serious adverse events (<1-2%) occurred in similar proportions across fremanezumab and placebo groups. CVAEs were infrequent, regardless of cardio- and cerebrovascular medical history (2-6%). CVAEs occurred in low, similar proportions of patients with CVRFs and those using cardio- and cerebrovascular medications or triptans. No cardio- and cerebrovascular signals were identified. CONCLUSION: Fremanezumab demonstrated a favorable overall and cardio- and cerebrovascular safety profile in more than 2800 patients with episodic migraine or chronic migraine, regardless of cardio- and cerebrovascular medical history, CVRFs, or medication use.Trial Registrations: NCT02629861 (HALO EM, https://clinicaltrials.gov/ct2/show/NCT02629861), NCT02621931 (HALO CM, https://clinicaltrials.gov/ct2/show/NCT02621931), NCT03308968 (FOCUS, https://clinicaltrials.gov/ct2/ show/NCT03308968).

Design and verification of a measurement setup for wireless remote microphone systems (WRMSs).

OBJECTIVE: This work presents the design and verification of a simplified measurement setup for wireless remote microphone systems (WRMSs), which has been incorporated into guidelines of the European Union of Hearing Aid Acousticians (EUHA). DESIGN: Three studies were conducted. First, speech intelligibility scores within the simplified setup were compared to that in an actual classroom. Second, different WRMSs were compared in the simplified setup, and third, normative data for normal-hearing people with and without WRMS were collected. STUDY SAMPLE: The first two studies include 40 older hearing impaired and the third study 20 young normal-hearing adults. RESULTS: Speech intelligibility with WRMS was not different across actual classroom and simplified setup. An analog omnidirectional WRMS showed poorer speech intelligibility and poorer quality ratings than digital WMRSs. The usage of a WRMS in the simplified setup resulted in significantly higher speech intelligibility across all tested background noise levels. CONCLUSIONS: Despite being a simplified measurement setup, it realistically emulates a situation where people are listening to speech in noise from a distance, such as in a classroom or meeting room. Hence, with standard audiological equipment, the individual benefit of WRMSs can be measured and experienced by the user in clinical practice.

[CGRP antibodies in migraine prophylaxis : The new standard in migraine treatment?] / CGRP-Antikörper in der Migräneprophylaxe : Der neue Standard in der Migränetherapie?

Migraine is associated with a high individual level of suffering. Therefore, an effective preventive treatment is highly important. The spectrum of classical prophylactic drugs has now been expanded to include monoclonal antibodies against calcitonin gene-related peptide (CGRP) and its receptor. These antibodies have shown reliable efficacy compared to placebo and a rapid onset of action with a low rate of side effects and negligible interactions in pivotal studies. Recently, the efficacy of the antibody was shown in many studies even on drug-refractory migraine and migraine associated with medication overuse. Comprehensive head to head comparisons with previously established drugs and among the antibodies are not yet available; however, initial studies suggest better tolerability and efficacy compared to conventional drugs and other antibodies. The role of antibodies in established treatment cascades still needs to be clarified.

The headache registry of the German Migraine and Headache Society (DMKG): baseline data of the first 1,351 patients.

BACKGROUND: Although good treatment options exist for many headache disorders, not all patients benefit and disability continues to be large. To design strategies for improving headache care, real-world data observing standard care is necessary. Therefore, the German Migraine and Headache Society (DMKG) has established the DMKG Headache Registry. Here we present methods and baseline data. METHODS: Accredited German headache centers (clinic-based or private practice) can offer participation to their patients. Patients provide headache history, current headache load (including a mobile headache diary), medication and comorbidities and answer validated questionnaires, prior to their physician appointment. Physicians use these data as the base of their history taking, and add, change or confirm some central information. Before the next visit, patients are asked to update their data. Patients will continuously be included over the next years. RESULTS: The present analysis is based on the first 1,351 patients (1110 females, 39.6 ± 12.9 years) with a completed first visit. Most participants had a migraine diagnosis. Participants had 14.4 ± 8.5 headache days and 7.7 ± 6.1 acute medication days per month and 63.9% had a migraine disability assessment (MIDAS) grade 4 (severe disability). 93.6% used at least one acute headache medication, most frequently a triptan (60.0%) or non-opioid analgesic (58.3%). 45.0% used at least one headache preventive medication, most frequently an antidepressant (11.4%, mostly amitriptyline 8.4%) or a CGRP(receptor) antibody (9.8%). Most common causes for discontinuation of preventive medication were lack of effect (54.2%) and side effects (43.3%). CONCLUSION: The DMKG Headache Registry allows to continuously monitor headache care at German headache centers in both a cross-sectional and a longitudinal approach. TRIAL REGISTRATION: The DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081 ).

Optimizing telemedical care in neurological outpatients by characterizing the patients' needs in the physician-patient relationship-content analysis of guideline-based interviews.

BACKGROUND: The use of new concepts in patient care, such as video-consultations, reminder systems, and online evaluation portals, is becoming increasingly important in the physician-patient relationship and outpatient care. This study examines the acceptance of these approaches in a neurological setting and determines the patients' preferences. METHODS: We analyzed 16 guideline-based qualitative interviews with neurological patients using qualitative content analysis (inductive category formation). RESULTS: The patients commented on the benefits and challenges of integrating new concepts of medical care. They identified advantages of telemedical care, including time savings (7 of 16; 43,8%) for both the patient and the physician, the prospect of more intensive (4 of 16; 25%) care, and the possibility for a quick response in case of urgent needs (3 of 16; 18.8%). Several challenges were reported, such as the limitations for patients with psychiatric (2 of 16; 12.5%) or complex diseases (4 of 16; 25%) and limited options for diagnostic procedures (such as physical examination (4 of 16; 25%)). For individual neurological patients' needs, telemedical and telecommunication structures could be discussed, which support the patients' specific requirements, such as answering questions while having a recall (2 of 16; 12.5%) and avoiding the journey (8 of 16; 50%). Also, patients are rejecting evaluation portals and are skeptical of telecare in the treatment of neurological diseases. DISCUSSION: The perception of telemedical care and the successful integration of new medical care concepts depend on fulfilling the individual patient's needs. Regardless of the preferred nature of physician-patient interactions, there are specific instruments that can intensify the relationship. These individual needs of the patients must be inquired about and accommodated for. CONCLUSIONS: For the first time, we could characterize the properties of optimal telemedical care for neurological patients. Interviews like the ones we conducted should be repeated during and after the pandemic, referring to our results and compare.

Neuromodulation in primary headaches: current evidence and integration into clinical practice.

PURPOSE OF REVIEW: Neuromodulatory approaches add to our armamentarium of therapeutic tools for the treatment of primary headaches. This review provides a comprehensive overview of current controlled studies on the different neuromodulation techniques and recommendations for clinical practice. RECENT FINDINGS: Evidence for efficacy of transcutaneous vagal nerve stimulation (tVNS) is limited to acute use in migraine with ambiguous results and episodic cluster headache as well as chronic cluster headache if applied in addition to conventional treatment. Transcutaneous stimulation of the supraorbital and supratrochlear nerve was effective in both acute and preventive stimulation (the latter with ambiguous results) in episodic migraines. Thus, invasive procedures should be reserved for severe and refractory cases only. Occipital nerve stimulation for chronic refractory cluster headache is the only available invasive approach with a Conformité Européenne mark. SUMMARY: Neuromodulation can complement conventional therapy, with noninvasive procedures being used preferably. Given the limited number of studies for each modality and the lack of head-to-head studies, it is difficult to place neuromodulation techniques in a conventional treatment algorithm.

Effect of calcitonin gene-related peptide (-receptor) antibodies in chronic cluster headache: Results from a retrospective case series support individual treatment attempts.

OBJECTIVE: To assess the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor in chronic cluster headache (CCH) treatment under real world conditions. BACKGROUND: Calcitonin gene-related peptide has an important pathophysiological role in cluster headache. Although the randomised controlled trial with the calcitonin gene-related peptide antibody galcanezumab was negative, chronic cluster headache patients with insufficient response to other preventive treatments have been receiving individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies. METHODS: Data from 22 chronic cluster headache patients who received at least one dose of a calcitonin gene-related peptide(-receptor) antibody and recorded attack frequency in a headache diary were retrospectively collected at eight headache centres. RESULTS: The number of previous preventive therapies was 6.5 ± 2.4 (mean ± standard deviation, range: 2-11). The average number of attacks per week was 23.3 ± 16.4 at baseline and significantly decreased by -9.2 ± 9.7 in the first month of treatment with a calcitonin gene-related peptide(-receptor) antibody (p < 0.001). Fifty-five percent of the patients were 50% responders and 36% were 75% responders with respect to attack frequency. Significant reduction of attack frequency started at week 1 (-6.8 ± 2.8 attacks, p < 0.01). Results were corroborated by significant decreases in weekly uses of acute headache medication (-9.8 ± 7.6, p < 0.001) and pain intensity during attacks (-1.2 ± 2.0, numerical rating scale (NRS) [0-10], p < 0.01) in the first month. In months 2 (n = 14) and 3 (n = 10), reduction of attack frequency from baseline was -8.0 ± 8.4 (p = 0.004) and -9.1 ± 10.0 (p = 0.024), respectively. CONCLUSION: Under real-world conditions, individual treatment with calcitonin gene-related peptide(-receptor) antibodies was effective in 55% of our chronic cluster headache patients. This finding supports individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies in chronic cluster headache patients insufficiently responding to other therapies.

[Migraine prophylaxis-all just antibodies? : Medical and nonmedical migraine preventive treatment in times of CGRP antibodies]. / Migräneprophylaxe ­ alles nur noch Antikörper? : Medikamentöse und nicht-medikamentöse Migräneprophylaxe in Zeiten der CGRP-Antikörper.

BACKGROUND: Migraine is a frequently underdiagnosed disease that is associated with a high burden on affected patients. There are a variety of prophylactic treatment options available, that have been expanded with the introduction of the CGRP-(receptor-)antibodies. OBJECTIVES: Status of pharmacologic and nonpharmacologic preventive treatment in migraine therapy. METHODS: Analysis and evaluation of internationally published articles concerning preventive treatment of episodic and chronic migraine. RESULTS: There are many approved medications for migraine prophylaxis with different evidence. The possibilities were further expanded with CGRP antibodies. Comparative studies of the new antibodies with previous prophylactic drugs have not yet been published, so it's unclear whether the antibodies are therapeutically superior. What should be emphasized is their rapid onset of action and their good tolerance. Basically, an individual choice of prophylaxis, which is based on affectedness, comorbidities and comedication, makes sense. In addition, a combination with nondrug measures is always mandatory. CONCLUSIONS: A variety of medicinal and non-medicinal measures are available for the treatment of migraine, which should be used multimodally.