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Abstract
Head motion during magnetic resonance imaging (MRI) induces image artifacts that affect virtually every brain measure. In parallel, cross‐sectional observations indicate a correlation of head motion with age, psychiatric disease status and obesity, raising the possibility of a systematic artifact‐induced bias in neuroimaging outcomes in these conditions, due to the differences in head motion. Yet, a causal link between obesity and head motion has not been tested in an experimental design. Here, we show that a change in body mass index (BMI) (i.e., weight loss after bariatric surgery) systematically decreases head motion during MRI. In this setting, reduced imaging artifacts due to lower head motion might result in biased estimates of neural differences induced by changes in BMI. Overall, our finding urges the need to rigorously control for head motion during MRI to enable valid results of neuroimaging outcomes in populations that differ in head motion due to obesity or other conditions.
Objective
To evaluate individual and group long-term efficacy and safety of erenumab in individuals with episodic migraine (EM) for whom 2–4 prior preventatives had failed.
Methods
Participants completing the 12-week double-blind treatment phase (DBTP) of the LIBERTY study could continue into an open-label extension phase (OLEP) receiving erenumab 140 mg monthly for up to 3 years. Main outcomes assessed at week 112 were: ≥50%, ≥75% and 100% reduction in monthly migraine days (MMD) as group responder rate and individual responder rates, MMD change from baseline, safety and tolerability.
Results
Overall 240/246 (97.6%) entered the OLEP (118 continuing erenumab, 122 switching from placebo). In total 181/240 (75.4%) reached 112 weeks, 24.6% discontinued, mainly due to lack of efficacy (44.0%), participant decision (37.0%) and adverse events (AEs; 12.0%). The ≥50% responder rate was 57.2% (99/173) at 112 weeks. Of ≥50% responders at the end of the DBTP, 36/52 (69.2%) remained responders at ≥50% and 22/52 (42.3%) at >80% of visits. Of the non-responders at the end of the DBTP, 60/185 (32.4%) converted to ≥50% responders in at least half the visits and 24/185 (13.0%) converted to ≥50% responders in >80% of visits. Change from baseline at 112 weeks in mean (SD) MMD was −4.2 (5.0) days. Common AEs (≥10%) were nasopharyngitis, influenza and back pain.
Conclusions
Efficacy was sustained over 112 weeks in individuals with difficult-to-treat EM for whom 2–4 prior migraine preventives had failed. Erenumab treatment was safe and well tolerated, in-line with previous studies.
Trial registration number NCT03096834
Abstract
Objective
This study was undertaken to calculate epilepsy‐related direct, indirect, and total costs in adult patients with active epilepsy (ongoing unprovoked seizures) in Germany and to analyze cost components and dynamics compared to previous studies from 2003, 2008, and 2013. This analysis was part of the Epi2020 study.
Methods
Direct and indirect costs related to epilepsy were calculated with a multicenter survey using an established and validated questionnaire with a bottom‐up design and human capital approach over a 3‐month period in late 2020. Epilepsy‐specific costs in the German health care sector from 2003, 2008, and 2013 were corrected for inflation to allow for a valid comparison.
Results
Data on the disease‐specific costs for 253 patients in 2020 were analyzed. The mean total costs were calculated at €5551 (±€5805, median = €2611, range = €274–€21 667) per 3 months, comprising mean direct costs of €1861 (±€1905, median = €1276, range = €327–€13 158) and mean indirect costs of €3690 (±€5298, median = €0, range = €0–€11 925). The main direct cost components were hospitalization (42.4%), antiseizure medication (42.2%), and outpatient care (6.2%). Productivity losses due to early retirement (53.6%), part‐time work or unemployment (30.8%), and seizure‐related off‐days (15.6%) were the main reasons for indirect costs. However, compared to 2013, there was no significant increase of direct costs (−10.0%), and indirect costs significantly increased (p < .028, +35.1%), resulting in a significant increase in total epilepsy‐related costs (p < .047, +20.2%). Compared to the 2013 study population, a significant increase of cost of illness could be observed (p = .047).
Significance
The present study shows that disease‐related costs in adult patients with active epilepsy increased from 2013 to 2020. As direct costs have remained constant, this increase is attributable to an increase in indirect costs. These findings highlight the impact of productivity loss caused by early retirement, unemployment, working time reduction, and seizure‐related days off.
Abstract
Background and purpose:Diagnosing a patient with headache as a migraineur is critical for state-of-the-art migrainemanagement. Screening tools are imperative means to improve the diagnostic yield in the primary care settings andspecialized clinics. This study aims to translate and assess the diagnostic accuracy of a German version of theID Migraine™as a widely used and efficient screening instrument.
Methods:
The Functional Assessment of Chronic Illness Therapy translation methodology was used to translate theoriginal three-itemID Migraine™, including a fourth question for aura, from the English language into the German language.Diagnostic accuracy of the GermanID Migraine™and predictors of false screening results were assessed among patientspresenting to a headache outpatient clinic of a tertiary care center in Germany over a 6-month period.
Results:
The translation procedure yielded a harmonized GermanID Migraine™and its diagnostic accuracy was assessedin 105 patients (80 female, 46.5+17.2 years of age), including 79 patients (75.2%) with migraine. The three-item GermanID Migraine™provides a sensitivity of 99%, specificity of 68%, and positive and negative predictive values of 90% and 95%,respectively, using a cutoff of2. Positive and negative predictive values in a general headache population are estimated tobe 74% and 98%, respectively. The aura question identified 18 out of 20 migraineurs with aura.
Conclusions:
The GermanID Migraine™is an accurate screening tool for migraine even in a challenging population of aspecialized outpatient clinic. Its diagnostic accuracy indicates a potential utility for screening in primary health care.
Background: Intensive speech-language therapy (SLT) can promote recovery from chronic post-stroke aphasia, a major consequence of stroke. However, effect sizes of intensive SLT are moderate, potentially reflecting a physiological limit of training-induced progress. Transcranial direct current stimulation (tDCS) is an easy-to-use, well-tolerated and low-cost approach that may enhance effectiveness of intensive SLT. In a recent phase-II randomized controlled trial, 26 individuals with chronic post-stroke aphasia received intensive SLT combined with anodal-tDCS of the left primary motor cortex (M1), resulting in improved naming and proxy-rated communication ability, with medium-to-large effect sizes.
Aims: The proposed protocol seeks to establish the incremental benefit from anodal-tDCS of M1 in a phase-III randomized controlled trial with adequate power, ecologically valid outcomes, and evidence-based SLT.
Methods: The planned study is a prospective randomized placebo-controlled (using sham-tDCS), parallel-group, double-blind, multi-center, phase-III superiority trial. A sample of 130 individuals with aphasia at least 6 months post-stroke will be recruited in more than 18 in- and outpatient rehabilitation centers.
Outcomes: The primary outcome focuses on communication ability in chronic post-stroke aphasia, as revealed by changes on the Amsterdam-Nijmegen Everyday Language Test (A-scale; primary endpoint: 6-month follow-up; secondary endpoints: immediately after treatment, and 12-month follow-up). Secondary outcomes include measures assessing linguistic-executive skills, attention, memory, emotional well-being, quality of life, health economic costs, and adverse events (endpoints: 6-month follow-up, immediately after treatment, and 12-month follow-up).
Discussion: Positive results will increase the quality of life for persons with aphasia and their families while reducing societal costs. After trial completion, a workshop with relevant stakeholders will ensure transfer into best-practice guidelines and successful integration within clinical routine.
Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03930121.
Background: Stereotactic electroencephalography (SEEG) is an invasive diagnostic tool for localizing the epileptic zone in patients with medically refractory focal epilepsy. Despite technical and imaging advances in guiding the electrode placement, vascular injury is still one of its most serious complications. Object: To investigate the usefulness of intraoperative cerebral C-arm CT angiogram (CCTA) in avoiding intracranial hemorrhagic complications during SEEG electrode implantation. Methods: Trajectory data from 12 patients who underwent SEEG electrode implantation were studied in detail. This included an analysis of the implantation of 146 SEEG electrodes, which were guided by intraoperative CCTA, as well as the standard planning based on preoperative contrast-enhanced MRI. In addition, a prospective analysis of SEEG hemorrhagic complications using the studied methodology was performed in a total of 87 patients receiving 1,310 electrodes. Results: There was no complication related to the CCTA itself. Intraoperative CCTA entailed modification of the original trajectory based on the preoperative MRI in 27 of 146 electrode implantations (18.5%). In 10 of them, a severe vascular complication was adverted by intraoperative CCTA. The safety of this new approach was also confirmed by the analysis of postinterventional CT, which revealed a symptomatic hematoma caused by 1 single electrode out of the 1,310 implanted. Conclusions: This study showed that intraoperative CCTA in addition to preoperative MRI is useful in guiding a safer SEEG electrode implantation. The combination of both imaging modalities essentially minimizes the risk of serious hemorrhagic complications.
Background
Fatigue is a common symptom in patients with multiple sclerosis. Several studies suggest that outdoor temperature can impact fatigue severity, but a systematic study of seasonal variations is lacking.
Methods
Fatigue was assessed with the Fatigue Scale for Motor and Cognitive Functions (FSMC) in a temperate climatic zone with an average outdoor temperature of 8.8°C. This study included 258 patients with multiple sclerosis from 572 visits temporally distributed over the year. The data were adjusted for age, sex, cognition, depression, disease severity, and follow-up time. Linear regression models were performed to determine whether the temporal course of fatigue was time-independent, linearly time dependent, or non-linearly time dependent.
Results
Fatigue was lowest during January (mean FSMC: 49.84) and highest during August (mean FSMC: 53.88). The regression analysis showed the best fit with a model that included months + months2, which was a non-linear time dependency. Mean FSMC per month correlated significantly with the average monthly temperature (ρ = 0.972; p < 0.001).
Conclusion
In multiple sclerosis, fatigue showed a natural temporal fluctuation. Fatigue was higher during summer compared to winter, with a significant relationship of fatigue with outdoor temperature. This finding should be carefully taken into account when clinically monitoring patients over time to not interpret higher or lower scores independent of seasonal aspects.
The Role of Vascular Risk Factors in Post-Stroke Delirium: A Systematic Review and Meta-Analysis
(2022)
Vascular risk factors may predispose to post-stroke delirium (PSD). A systematic review and meta-analysis were performed by searching PubMed, Web of Science, and Scopus. The primary outcome was the prevalence of vascular risk factors in PSD vs. non-PSD patients. Odds ratios (ORs) with 95% confidence intervals (CIs) and mean differences (MDs) with 95% CIs were calculated for categorical and continuous variables, respectively. Fixed effects or random effects models were used in case of low- or high-statistical heterogeneity, respectively. We found an increased prevalence of atrial fibrillation (OR = 1.74, p = 0.0004), prior stroke (OR = 1.48, p < 0.00001), coronary artery disease (OR = 1.48, p < 0.00001), heart failure (OR = 2.01, p < 0.0001), and peripheral vascular disease (OR = 2.03, p < 0.00001) in patients with vs. without PSD. PSD patients were older (MD = 5.27 y, p < 0.00001) compared with their non-PSD counterparts. Advanced age, atrial fibrillation, prior stroke, coronary artery disease, heart failure, and peripheral vascular disease appeared to be significantly associated with PSD.