The Hard Palate Sweep: a multiplanar 2-dimensional sonographic method for the prenatal detection of cleft palate.

BACKGROUND: Prenatal diagnosis of cleft palate is challenging. Numerous 2-dimensional and 3-dimensional methods have been proposed to assess the integrity of the fetal palate, yet detection rates remain relatively low. We propose the "Hard Palate Sweep," a novel 2-dimensional method that enables clear demonstration of the entire fetal palate throughout pregnancy, in a single sweep, avoiding acoustic shadows cast by surrounding bones. OBJECTIVE: This study aimed to assess the feasibility and performance of the Hard Palate Sweep, performed throughout pregnancy. STUDY DESIGN: This was a prospective cross-sectional study performed between 2018 and 2022 in pregnant patients referred for a routine or targeted anomaly scan between 13 and 40 weeks of gestation. The presence or absence of a cleft palate was determined using the "Hard Palate Sweep." This was compared with the postnatal palate integrity assessment. Test feasibility and performance indices, including sensitivity, specificity, and positive and negative predictive values were calculated. Offline clips were reviewed by 2 investigators for the assessment of inter- and intraoperator agreement, using Cohen's kappa formula. The study protocol was approved by the institutional ethics committee. All participating patients were informed and provided consent. RESULTS: A total of 676 fetuses were included in the study. The Hard Palate Sweep was successfully performed in all cases, and 19 cases were determined to have a cleft palate. Of these, 13 cases were excluded because postmortem confirmation was not performed, leaving 663 cases available for analysis. Six cases determined to have a cleft palate were confirmed postnatally. In 655 of 657 cases prenatally determined to have an intact palate, this was confirmed postnatally. In the 2 remaining cases, rare forms of cleft palate were diagnosed postnatally, rendering 75% sensitivity, 100% specificity, 100% positive predictive value, and 99.7% negative predictive value for the Hard Palate Sweep (P<.001). There was complete intra- and interoperator agreement (kappa=1; P<.0001). CONCLUSION: The Hard Palate Sweep is a feasible and accurate method for prenatally detecting a cleft palate. It was successfully performed in all attempted cases between 13 and 40 weeks of gestation. This method is reproducible, offering high sensitivity and specificity. Implemented routinely, the Hard Palate Sweep is expected to increase the prenatal detection of cleft palate.

Migraine treatment with external concurrent occipital and trigeminal neurostimulation-A randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of concurrent non-invasive stimulation of occipital and trigeminal nerves in acute treatment of migraine with or without aura. BACKGROUND: Non-invasive neuromodulation devices stimulating a single peripheral nerve or anatomic distribution are routinely used by patients with migraine refractory to the first-line drugs or those who opt out of pharmaceutical treatment. Concurrent occipital and trigeminal stimulation was described in an invasive setting, and its safety cost outweighed its efficacy gain. This study evaluated the efficacy and safety of an external concurrent occipital and trigeminal device in acute treatment of migraine. DESIGN AND METHODS: This was a randomized, sham-controlled, double-blind, multi-center trial. Patients 18 years of age or older who met the International Classification of Headache Disorders (2018) diagnostic criteria for migraine with or without aura, reported 1-6 migraine attacks per month, and other headaches no more than 6 days per month were enrolled. Of 131 intention-to-treat participants (67 and 64 in the active and sham groups, respectively), 109 (50 and 59 in the active and sham groups, respectively) treated at least one migraine episode. Reduction of migraine headache (pain relief) 2 h after treatment initiation was the primary efficacy endpoint. Pain relief at 1 h, and pain freedom and relief in most bothersome symptom at 2 h after treatment initiation were the secondary endpoints. Freedom from most bothersome symptom at 2 h and sustained pain freedom 24 h after treatment initiation were among the exploratory endpoints. RESULTS: Sixty percent of participants (30/50) in the active arm reported pain relief at 2 h after initiation of the first eligible treatment (primary outcome) compared to 37% (22/59) in the control arm (difference, 23%; 95% confidence interval [CI], 2%-41%; p = 0.018). Pain freedom at 2 h without rescue medication was reported by 46% (23/50) of participants in the active arm and by 12% (7/59) of participants in the sham arm (p < 0.001). Pain freedom 2 h after the treatment and, subsequently, at 24 h, was reported by 4.25 times more participants in the active arm (36%; 18/50) than in the sham arm (8%; 5/59). The 28% difference was statistically significant (95% CI, 1%-43%; p < 0.001). A 4.25-fold difference was also observed comparing the proportion of participants free from pain and most bothersome symptom 2 h after the stimulation (47% [17/36] and 11% [5/45] in the active and sham arms, respectively; 95% CI, 14%-54%; p < 0.001). Adverse events were not serious or severe. All study-related events resolved without treatment. CONCLUSION: External concurrent occipital and trigeminal neurostimulation is a well-tolerated, safe, and effective migraine treatment that provided a fast and durable relief and freedom from migraine pain and associated symptoms in a randomized setting. The observed safety and performance suggest external concurrent occipital and trigeminal neurostimulation is a viable alternative to the currently available acute migraine treatments. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT03631550.

Comparison of Remote Electrical Neuromodulation and Standard-Care Medications for Acute Treatment of Migraine in Adolescents: A Post Hoc Analysis.

OBJECTIVE: There is an unmet need for new, efficacious, well-tolerated, acute treatments for migraine in adolescents. Remote electrical neuromodulation (REN) is a novel, nonpharmacological treatment that provides significant symptom relief with good tolerability. The current post hoc analysis compared the efficacy of REN to that of standard-care medications for the acute treatment of migraine in adolescents. DESIGN: Within-participant post hoc analysis of data from a clinical trial. SETTING: Data from a clinical trial. SUBJECTS: Data from 35 adolescent participants were analyzed. METHODS: Efficacy was compared between a run-in phase, in which attacks were treated with standard-care medications (triptans or over-the-counter medications), and an intervention phase, in which attacks were treated with REN. Efficacy was compared within participants through the use of McNemar's test at four endpoints (2 hours after treatment): single-treatment pain freedom and pain relief, and consistency of pain freedom and pain relief (defined as response in at least 50% of the available first four treatments). RESULTS: At 2 hours after treatment, pain freedom was achieved by 37.1% of the participants with REN, vs 8.6% of the participants with medications (P = 0.004). Pain relief was achieved by 71.4% with REN, vs 57.1% with medications (P = 0.225). Consistency of pain freedom was achieved by 40% with REN, vs 8.6% with medications (P < 0.001). Consistency of pain relief was achieved by 80.0% with REN, vs 57.2% with medications (P = 0.033). CONCLUSIONS: Our results suggest that REN may have higher efficacy than certain standard-care medications for the acute treatment of migraine in adolescents. A larger-scale, blinded comparative-effectiveness and tolerability study is needed.

Dynamic esophageal patency assessment: an effective method for prenatally diagnosing esophageal atresia.

BACKGROUND: Esophageal atresia is a major anomaly with a low prenatal detection rate. We propose a sonographic method termed dynamic esophageal patency assessment. OBJECTIVE: This study aimed to assess the feasibility and performance of the dynamic esophageal patency assessment in a high-risk population. STUDY DESIGN: A prospective study was conducted in a single tertiary fetal ultrasound unit for 12 months. The study group included pregnant women referred for a targeted scan because of one or more of the following: (1) polyhydramnios; (2) small or absent stomach; (3) vertebral, anal atresia, cardiac, tracheoesophageal fistula, renal, and limb abnormalities; (4) first-degree relative with esophageal atresia; and (5) genetic mutation associated with esophageal atresia. In addition to dynamic esophageal patency assessment, a comprehensive anomaly scan was carried out. The fetal esophagus was observed during swallowing. Cases that demonstrated uninterrupted fluid propagation through the esophagus were classified as normal. Cases that demonstrated interrupted fluid propagation, with the formation of a pouch, were classified as abnormal. Cases with unclear visualization of the esophagus or cases that failed to demonstrate either fluid propagation or a pouch were classified as undetermined. Dynamic esophageal patency assessment results were compared with postnatal findings, considered "gold standard." Test performance indices and intra- and interobserver agreements were calculated. RESULTS: For 12 months, 130 patients were recruited, and 132 fetuses were scanned. The median gestational age (interquartile range) at the time of scan was 31.4 weeks (29.0-35.3). Of 132 fetuses enrolled, 123 (93.2%) were normal, 8 (6%) were abnormal, and 1 (0.8%) was undetermined. Excluded from test performance analysis were 3 cases that were terminated without postmortem autopsy (1 was abnormal and 2 were normal), and a fourth case was excluded as it was classified as undetermined. The detection rate of esophageal atresia was 100%, with no false-positive or false-negative case. Sensitivity, specificity, and positive and negative predictive values of the dynamic esophageal patency assessment were 100%. The Kappa coefficient was 1 for both inter- and intraobserver agreements (P<.0001). The median time (interquartile range) required to complete the dynamic esophageal patency assessment was 6.00 minutes (3.00-13.25). CONCLUSION: The dynamic esophageal patency assessment is a feasible and highly effective method of ascertaining an intact esophagus and detecting esophageal atresia in suspected cases.

Erenumab-Induced Severe Nausea Leading to Smoking Cessation: A Retrospective Case Series.

OBJECTIVE: Erenumab is a novel treatment modality with a relatively benign and safe side effect profile, currently approved for the prevention of migraine headache. We present 3 cases with chronic migraine who are cigarette smokers were prescribed erenumab, and developed an intense smoking-induced nausea which eventually led to smoking cessation. METHODS: A multicenter retrospective review of 3 cases with cigarette smoking, one of whom was also smoking marijuana, suffering from chronic migraine resistant to multiple preventive therapies was studied. All were prescribed monthly injections of erenumab 70 mg. Response in terms of headache frequency and intensity and smoking habits was obtained through medical record review. RESULTS: Out of 3 patients, 2 reported reduced headache frequency and intensity. All patients developed severe nausea while smoking cigarettes after their first dose of erenumab, leading to smoking cessation. One patient co-smoked marijuana, which did not result in nausea after being treated. CONCLUSION: To the best of our knowledge, this is the first report of severe nausea secondary to erenumab administration and smoking cigarettes, which finally resulted in complete cigarette smoking cessation. As such, further study is indicated on the benefit of erenumab and other calcitonin gene-related peptide antagonists in migraineurs who smoke to promote smoking cessation.

Brain Protease Activated Receptor 1 Pathway: A Therapeutic Target in the Superoxide Dismutase 1 (SOD1) Mouse Model of Amyotrophic Lateral Sclerosis.

Glia cells are involved in upper motor neuron degeneration in amyotrophic lateral sclerosis (ALS). Protease activated receptor 1 (PAR1) pathway is related to brain pathologies. Brain PAR1 is located on peri-synaptic astrocytes, adjacent to pyramidal motor neurons, suggesting possible involvement in ALS. Brain thrombin activity in superoxide dismutase 1 (SOD1) mice was measured using a fluorometric assay, and PAR1 levels by western blot. PAR1 was localized using immunohistochemistry staining. Treatment targeted PAR1 pathway on three levels; thrombin inhibitor TLCK (N-Tosyl-Lys-chloromethylketone), PAR1 antagonist SCH-79797 and the Ras intracellular inhibitor FTS (S-trans-trans-farnesylthiosalicylic acid). Mice were weighed and assessed for motor function and survival. SOD1 brain thrombin activity was increased (p < 0.001) particularly in the posterior frontal lobe (p = 0.027) and hindbrain (p < 0.01). PAR1 levels were decreased (p < 0.001, brain, spinal cord, p < 0.05). PAR1 and glial fibrillary acidic protein (GFAP) staining decreased in the cerebellum and cortex. SOD1 mice lost weight (≥17 weeks, p = 0.047), and showed shorter rotarod time (≥14 weeks, p < 0.01). FTS 40mg/kg significantly improved rotarod scores (p < 0.001). Survival improved with all treatments (p < 0.01 for all treatments). PAR1 antagonism was the most efficient, with a median survival improvement of 10 days (p < 0.0001). Our results support PAR1 pathway involvement in ALS.

An Analysis of UCNS Certified Headache Center Patient Intake Forms.

OBJECTIVE: Compare the similarities and differences among headache intake forms from headache centers with United Council of Neurologic Subspecialties (UCNS) accredited headache medicine fellowships in the United States. Patient intake forms establish a first communication with patients. There have been no studies evaluating them at headache centers. Analysis of these forms can provide insight into their content and potential for improvement. METHODS: This observational study involved collection and analysis of intake forms from 25 UCNS fellowship accredited headache centers from July 2014 to October 2014. Forms were compared and contrasted in terms of data fields included, response format, and use of validated assessment tools. RESULTS: Forms shared many common elements, yet were highly variable in content, style, scales, and methods of analysis. Twenty percent (5/20) of centers did not have a formal intake form. Forms ranged from 1 to 28 pages. Seventy percent (12/17) utilized a check box format, 23% (4/17) utilized an open ended/fill in the blank format, and 6% (1/17) utilized a circle the response(s) format. Family history was inquired about in 82% (14/17) of forms and past medical history (PMH) in 58% (10/17) of forms. Gender questions were asked 82% (14/17) of the time for women, 29% (5/17) for men. Eighty-eight percent (15/17) of forms had questions concerning any type of previous medication tried. DISCUSSION: Patient intake forms are useful for clinical purposes, but vary markedly between UCNS headache centers. Ultimately, a universal intake form could be generated, providing a research-based alternative to the form currently used at each center. Use of a standardized intake form by UCNS centers would streamline data collection, a good first step in the eventual generation of a headache registry.

Headache Rounds: Sudden, Transient Neurologic Symptoms in a Woman With Migraine.

The following article is a Graham Headache Center headache rounds presentation at the Brigham and Women's Faulkner Hospital by fellows Roni Sharon and Melissa Rayhill with special guest Tobias Kurth. It summarizes the case of a 36-year-old female with no history of migraine in the past, presenting with several transient neurological episodes associated with headache. Her history, symptoms, imaging workup is reviewed. Following the case is a discussion of the differential diagnosis for the patient's symptoms along with a review of the association of migraine with and without aura with vascular neurological insult such as stroke. The article also discusses the clinical implications of migraine as a risk factor for stroke along with possible treatment recommendations.

Preoperative Pain Catastrophizing and Neuropathic Pain Do Not Predict Length of Stay and Early Post-Operative Complications following Total Joint Arthroplasty.

BACKGROUND: Both pain catastrophizing and neuropathic pain have been suggested as prospective risk factors for poor postoperative pain outcomes in total joint arthroplasty (TJA). OBJECTIVE: We hypothesized that pain catastrophizers, as well as patients with pain characterized as neuropathic, would exhibit higher pain scores, higher early complication rates and longer lengths of stay following primary TJA. METHODS: A prospective, observational study in a single academic institution included 100 patients with end-stage hip or knee osteoarthritis scheduled for TJA. In pre-surgery, measures of health status, socio-demographics, opioid use, neuropathic pain (PainDETECT), pain catastrophizing (PCS), pain at rest and pain during activity (WOMAC pain items) were collected. The primary outcome measure was the length of stay (LOS) and secondary measures were the discharge destinations, early postoperative complications, readmissions, visual analog scale (VAS) levels and distances walked during the hospital stay. RESULTS: The prevalence of pain catastrophizing (PCS ≥ 30) and neuropathic pain (PainDETECT ≥ 19) was 45% and 20.4%, respectively. Preoperative PCS correlated positively with PainDETECT (rs = 0.501, p = 0.001). The WOMAC positively correlated more strongly with PCS (rs = 0.512 p = 0.01) than with PainDETECT (rs = 0.329 p = 0.038). Neither PCS nor PainDETECT correlated with the LOS. Using multivariate regression analysis, a history of chronic pain medication use was found to predict early postoperative complications (OR 38.1, p = 0.47, CI 1.047-1386.1). There were no differences in the remaining secondary outcomes. CONCLUSIONS: Both PCS and PainDETECT were found to be poor predictors of postoperative pain, LOS and other immediate postoperative outcomes following TJA.

External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial.

INTRODUCTION: Current external peripheral nerve stimulation devices stimulate only one nerve. This prospective, randomized, double-blind, sham-controlled trial assessed efficacy, safety, and tolerability of a novel external combined occipital and trigeminal neurostimulation (eCOT-NS) device as a self-administered home treatment for migraine (Relivion®MG, Neurolief Ltd; Netanya, Israel). METHODS: Episodic and chronic migraine subjects (N = 55) were randomized to receive active (n = 27) or sham (n = 28) treatment. Subjects received eCOT-NS devices and performed 60 ± 20-min home treatments within 45 min of migraine episode onset. The primary endpoint was relative (percent) change in mean baseline VAS pain scores 1 h after treatment initiation. Treatment outcomes assessed at 1-, 2-, and 24-h post-treatment initiation were pain reduction and proportion of pain-free subjects and treatment responders, defined as ≥ 50% pain reduction. Categorical pain ratings (none, mild, moderate, and severe pain) were also analyzed. RESULTS: Active stimulation was significantly more effective than sham stimulation for decreasing pain intensity at 1 h (53% vs. 10%), 2 h (52% vs. 17%), and 24 h (71% vs. 34%). Pain-free ratings were greater for the active treatment arm at 1 h (29.2% vs. 16%), 2 h (41.7% vs. 20%), and 24 h (65.2% vs. 40%). The number of subjects with baseline moderate or severe migraine pain who were pain-free at 2 h was significantly greater among active treatment subjects (43% vs. 10.5%). The responder rate was significantly higher among the active treatment group at 1 h (67% vs. 20%), 2 h (66.7% vs. 32%,), and 24 h (78.3% vs. 48%). Overall headache relief was significantly higher in the active treatment group at 1 h (67% vs. 26%) and 2 h (76% vs. 31.6%). Mild adverse events, reported by a minority of subjects, resolved spontaneously. CONCLUSIONS: eCOT-NS provides superior clinically meaningful relief and freedom from migraine pain, offering an effective and safe therapy for acute treatment of migraine. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03398668.

As current external nerve stimulation devices stimulate only one nerve, this study assessed the effectiveness, safety, and tolerability of a new external nerve stimulation device that stimulates two nerves (occipital and trigeminal) as a self-administered home treatment for migraine (Relivion^®MG, Neurolief Ltd; Netanya, Israel). Fifty-five subjects with episodic and chronic migraine were randomly assigned to active (n = 27) or sham (dummy) treatment (n = 28). Subjects performed a 60-min home treatment within 45 min of migraine onset. The primary endpoint was the change in pain intensity 1 h after treatment initiation. Active treatment was significantly more effective than sham stimulation for decreasing pain intensity at 1 h (53% vs. 10%) and 2 h (52% vs. 17%). Pain-free ratings were also greater for the active treatment arm at 1 h (29.2% vs. 16%) and 2 h (41.7% vs. 20%). Overall headache relief was significantly higher in the active treatment group at 1 h (67% vs. 26%) and 2 h (66.7% vs. 32%). Mild, transient side effects reported by a few subjects resolved without treatment. This new external concurrent occipital and trigeminal neurostimulation (eCOT-NS) device provides superior and meaningful relief and freedom from migraine pain compared to sham treatment.

Race, Ethnicity, and Other Sociodemographic Characteristics of Patients with Hospital Admission for Migraine in the United States.

ABSTRACTBACKGROUND: Despite the growing awareness across the general population, migraine is often underdiagnosed and undertreated in socially and economically marginalized groups. The present study aimed to investigate the differential effects of race and income on other sociodemographic data and hospital length of stay in patients admitted to hospital with a primary diagnosis of migraine headache. METHODS: We utilized the Nationwide Inpatient Sample (NIS) database to identify patients admitted from 2004 to 2017 with a primary diagnosis of migraine. Information on demographic and length of stay data was obtained. Only patients older than 18 years were selected and age outliers were excluded. Race groups were identified as "Caucasian", "African American", "Hispanic", "Asian or Pacific Islander", "Native American", or "Others". Income was identified as the estimated median household income of residents in the patient's ZIP Code. RESULTS: A total of 106,761,737 valid cases were identified. After applying our case inclusion criteria, only 61453 (median age = 42 years, range = 18-78 years) were included. Patients identified as "African American", "Hispanic" or "Native American" were more likely to have lower household income (p< 0.001), whereas higher income was found for the patients identified as "Caucasian", even when men and women were considered separately (p< 0.001). No effects of race and/or household income was found on the length of stay in hospital. IMPLICATIONS: The occurrence of migraine diagnosis on hospital admission in the USA can be impacted by culturally driven patient-clinician communication differences between ethnic groups.

A device review of Relivion®: an external combined occipital and trigeminal neurostimulation (eCOT-NS) system for self-administered treatment of migraine and major depressive disorder.

Introduction: Many patients with migraine are non-responsive or intolerant to pharmaceutical or surgical interventions. Peripheral nerve stimulation (PNS) offers a potential solution for these patients. This review discusses the external combined occipital and trigeminal neurostimulation (eCOT-NS) provided by the Relivion®, a multi-channel head-mounted device for self-administered PNS.Areas covered: Challenges and advantages of PNS systems for the treatment of migraine and depression are introduced, followed by an overall review of clinical evidence of the efficacy of the Relivion® system in treating migraine. The supporting smartphone app and cloud-based analytics which enable remote treatment management by the health care provider are also discussed. Recent empirical indications for the potency of this PNS combination for the treatment of depression are also summarized.Expert opinion: Relivion® is an eCOT-NS system, featuring Food and Drug Administration-approved, noninvasive, self-administered, customizable, multi-focal PNS for the treatment of migraine. In accordance with current telehealth trends, the Relivion® also enhances remote disease management and personalization using digital-monitoring, cloud-based technology, and artificial intelligence. As research on this system progresses, it may become the preferred treatment for the management of a number of neurological and psychiatric diseases, with migraine and major depressive disorders as precedents.

Transient Horner syndrome associated with COVID-19: A case report.

The Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), has spread as a global pandemic with significant morbidity and mortality. As the prevalence of COVID-19 has risen, so has the diversity of its clinical presentation. SARS-CoV-2 is considered to have neuroinvasive and neurotropic qualities that can lead to central and peripheral nervous system manifestations. We describe a 65-year-old woman who developed new-onset unilateral ptosis and mitosis following a diagnosis of COVID-19. To our knowledge, this is the first reported case describing transient Horner syndrome in association with COVID-19.

Efficacy of Erenumab in the Treatment of Trigeminal Neuralgia: A Retrospective Case Series.

OBJECTIVE: Trigeminal neuralgia (TN) is a chronic, often refractory, pain condition, which adversely affects the lives of patients. Current treatments are only mildly effective. Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies have been successfully studied in the treatment of migraines. CGRP plays a role in both TN and migraine. It is prudent to attempt CGRP monoclonal antibody therapy in TN. Erenumab, a human anti-CGRP monoclonal antibody medication, modulates CGRP, which is elevated in patients with TN. The primary objective of this study was to evaluate the efficacy of erenumab for patients with TN. METHODS: Retrospective analysis was performed on data collected from 10 patients diagnosed with TN and treated with erenumab for 6 months. Pain was tracked using a numeric pain rating scale (NPRS) from 0 to 10. The effect of erenumab on NPRS after 6 months' time was the primary end point. Secondary end points included side effects to therapy, improvement in headache frequency in those with comorbid migraine, evaluating mood following therapy, and global mood improvement using scale (worse, no change, improved). RESULTS: Nine of 10 patients (90.0%) reported improvement in pain severity and in global mood improvement. Three patients reported resolution of anxiety and/or depression. Side effects were minimal, with 3 patients reporting constipation, injection site reactions, or both. CONCLUSIONS: Based on these results, erenumab appears to be an efficacious treatment option for patients with refractory TN. Patients experienced improvement in pain, reduced frequency of headache, and improvement in mood. Treatment was well tolerated with only mild side effects reported. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that erenumab increases the probability of improved pain control in patients with medication-resistant TN.

Remote Electrical Neuromodulation (REN) for the Acute Treatment of Menstrual Migraine: a Retrospective Survey Study of Effectiveness and Tolerability.

INTRODUCTION: Migraine is one of the most prevalent neurological disorders worldwide, and estimations are that 60% of women who suffer from migraines experience attacks that are associated with menstruation. Menstrual migraines are typically more debilitating and less responsive to pharmacological treatment. Remote electrical neuromodulation (REN) is a non-pharmacological abortive treatment of migraine headache. The current study evaluated the self-reported effectiveness and tolerability of REN for the acute treatment of menstrual migraine, via a retrospective structured survey that was sent to adult female REN users. METHODS: Women aged 18-55 years who experience menstrually related or pure menstrual migraine and have completed at least four REN treatments, participated in this retrospective, observational survey study. Participants completed a short online survey assessing effectiveness, satisfaction, and safety outcomes. RESULTS: Ninety-one participants qualified for the analysis, out of which 74.7% (68/91) reported that the treatment was at least moderately effective (moderately effective 37.4%, very effective 26.4%, extremely effective 11.0%). Additionally, 45.1% (41/91) reported satisfaction from REN (slightly satisfied 33%, extremely satisfied 12.1%), while 34.1% were neutral and 20.9% (19/91) were not satisfied. Lastly, 100% of the participants reported that the treatment is at least moderately tolerable (moderately tolerable 8.8%, very tolerable 20.9%, extremely tolerable 70.3%), and 13.2% (12/91) of respondents reported mild short-term side effects. CONCLUSIONS: Nearly 75% reported that the treatment was at least moderately effective, 45% reported satisfaction, and 100% of the participants reported that the treatment is at least moderately tolerable. Thirteen percent reported mild short-term side effects. REN was thus reported as effective for menstrual migraine by most participants and was very well tolerated. Therefore, REN may provide a safe, non-pharmacological alternative for the acute treatment of menstrual migraine. CLINICALTRIAL. GOV REGISTRATION NUMBER: NCT04600388.

Comparison of Two Tourniquets on a Mid-Thigh Model: The Israeli Silicone Stretch and Wrap Tourniquet vs. The Combat Application Tourniquet.

Introduction: Experience from recent conflicts underlines the dramatic impact of effective tourniquet use on combat casualty mortality. Although the Combat Application Tourniquet (CAT) is replacing the silicone band tourniquets (IST; "Israeli Silicone Tourniquet") in the Israeli Defense Forces, no direct comparison was made between them. The purpose of this study is to compare the performance of the two tourniquets on a mid-thigh model. Methods: Participants were Israeli military recruits who previously had the military first aid course. Each participant applied both the CAT and the IST. Applications were assessed by the HapMed Leg Tourniquet Trainer, which measured the applied pressure and the time required to reach it. Results: IST application resulted in higher rates of effective occlusion pressure compared with the CAT (91% vs. 73.1%, p < 0.01), and a higher mean occlusion pressure (41 mmHg, p < 0.01) was recorded using the IST. Among effective attempts, application time did not differ significantly between the tourniquets. Conclusion: The IST was superior to the CAT in producing effective occlusion pressure while not prolonging application time. These results may indicate that the IST remains a valid option for controlling mid-thigh bleeding.

Registration status and outcome reporting of trials published in core headache medicine journals.

OBJECTIVES: To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. METHODS: We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. RESULTS: The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. CONCLUSIONS: Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue.