Effects of acetyl-DL-leucine on cerebellar ataxia (ALCAT trial): study protocol for a multicenter, multinational, randomized, double-blind, placebo-controlled, crossover phase III trial.

BACKGROUND: Cerebellar ataxia (CA) is a frequent and often disabling condition that impairs motor functioning and impacts on quality of life (QoL). No medication has yet been proven effective for the symptomatic or even causative treatment of hereditary or non-hereditary, non-acquired CA. So far, the only treatment recommendation is physiotherapy. Therefore, new therapeutic options are needed. Based on three observational studies, the primary objective of the acetyl-DL-leucine on ataxia (ALCAT) trial is to examine the efficacy and tolerability of a symptomatic therapy with acetyl-DL-leucine compared to placebo on motor function measured by the Scale for the Assessment and Rating of Ataxia (SARA) in patients with CA. METHODS/DESIGN: An investigator-initiated, multicenter, European, randomized, double-blind, placebo-controlled, 2-treatment 2-period crossover phase III trial will be carried out. In total, 108 adult patients who meet the clinical criteria of CA of different etiologies (hereditary or non-hereditary, non-acquired) presenting with a SARA total score of at least 3 points will be randomly assigned in a 1:1 ratio to one of two different treatment sequences, either acetyl-DL-leucine (up to 5 g per day) followed by placebo or vice versa. Each sequence consists of two 6-week treatment periods, separated by a 4-week wash-out period. A follow-up examination is scheduled 4 weeks after the end of treatment. The primary efficacy outcome is the absolute change in the SARA total score. Secondary objectives are to demonstrate that acetyl-DL-leucine is effective in improving (1) motor function measured by the Spinocerebellar Ataxia Functional Index (SCAFI) and SARA subscore items and (2) QoL (EuroQoL 5 dimensions and 5 level version, EQ-5D-5 L), depression (Beck Depression Inventory, BDI-II) and fatigue (Fatigue Severity Score, FSS). Furthermore, the incidence of adverse events will be investigated. DISCUSSION: The results of this trial will inform whether symptomatic treatment with the modified amino-acid acetyl-DL-leucine is a worthy candidate for a new drug therapy to relieve ataxia symptoms and to improve patient care. If superiority of the experimental drug to placebo can be established it will also be re-purposing of an agent that has been previously used for the symptomatic treatment of dizziness. TRIAL REGISTRATION: The trial was prospectively registered at www.clinicaltrialsregister.eu (EudraCT no. 2015-000460-34) and at https://www.germanctr.de (DRKS-ID: DRKS00009733 ).

Effects of trimester-specific and total gestational weight gain on children's anthropometrics.

BACKGROUND: Gestational weight gain (GWG) has been shown to be a risk factor for overweight in offspring.Aim of this study was to quantify the contributions of trimester-specific and total GWG on offspring's BMI and waist circumference (WC). This is of interest for the design of interventions targeted at women showing a high GWG in early pregnancy. METHODS: In a retrospective cohort study data on GWG (total and by trimester, exposure), a number of potential confounders, and children's BMI z-scores and WC (outcomes) were analyzed using structural equation models to disentangle the trimester-specific direct effects of GWG and indirect effects mediated via total GWG. RESULTS: 7313 mother child pairs with a children's mean age of 5.81 years were analyzed. Total effects (indirect + direct) of GWG (kg/week) on children's BMI z-score and WC (cm) were observed in all trimesters, most prominently in the second. The longitudinal effect of GWG is a composite of trimester-specific direct effects (on BMI: 0.105, 0.255, 0.002, on WC: 0.538, 1.64, 0.308) and total GWG (on BMI 0.608, on WC: 1.03) at the end of pregnancy. CONCLUSIONS: Both trimester-specific priming and total GWG explained offspring's anthropometrics. The results indicate, that reversal from additional weight gain attained early in pregnancy resulting in normal total GWG at the end of pregnancy might still contribute to a substantial reduction of offspring's BMI and WC.

Prevention of headache in adolescents: population-attributable risk fraction for risk factors amenable to intervention.

INTRODUCTION: Several risk factors for headache have been identified, some of which are potentially amenable to interventions. The potential effect of such interventions can be predicted by the population-attributable risk fraction (PARF). We assessed PARFs of the the following risk factors: neck muscle pain, chronic stress, alcohol consumption, smoking, coffee consumption, and physical inactivity. We studied the maximal possible effect achievable by avoidance of these risk factors. METHODS: Two approaches to estimate PARFs are compared, which assess their cumulative and individual impact of risk factors by age: the Levin formula and the average attributable fraction. RESULTS: The overall impact for removal of all six risk factors amounts to 19.7% for the average attributable fraction. Neck tension and consumption of alcohol ranked as the strongest population-attributable risk factor for any headache. The potential impact for migraine was considerably higher (43.8%). With increasing age, the overall impact of risk factors on headache increases by 18.9%. CONCLUSION: Based on the estimations of the most appropriate approach, up to 20% of headaches in general and up to 43% of migraine in adolescents might be preventable by removing risk factors amenable to intervention, with increasing proportions by age.

The Semont-Plus Maneuver or the Epley Maneuver in Posterior Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Study.

Importance: Questions remain concerning treatment efficacy for the common condition of benign paroxysmal positional vertigo (BPPV). Objective: To compare the effectiveness of the Semont-plus maneuver (SM-plus) and the Epley maneuver (EM) for treatment of posterior canal benign paroxysmal positional vertigo (pcBPPV) canalolithiasis. Design, Setting, and Participants: This prospective randomized clinical trial was performed at 3 national referral centers (in Munich, Germany; Siena, Italy; and Bruges, Belgium) over 2 years, with a follow-up to 4 weeks after the initial examination. Recruitment took place from June 1, 2020, until March 10, 2022. Patients were selected randomly during routine outpatient care after being referred to 1 of the 3 centers. Two hundred fifty-three patients were assessed for eligibility. After consideration of the exclusion criteria as well as informed consent, 56 patients were excluded and 2 declined to participate, with 195 participants included in the final analysis. The analysis was prespecified and per-protocol. Interventions: After being randomized to the SM-plus or the EM group, patients received 1 initial maneuver from a physician, then subsequently performed self-maneuvers at home 3 times in the morning, 3 times at noon, and 3 times in the evening. Main Outcome and Measures: Patients had to document whether they could provoke positional vertigo every morning. The primary end point was the number of days until no positional vertigo could be induced on 3 consecutive mornings. The secondary end point was the effect of the single maneuver performed by the physician. Results: Of the 195 participants included in the analysis, the mean (SD) age was 62.6 (13.9) years, and 125 (64.1%) were women. The mean (SD) time until no positional vertigo attacks could be induced in the SM-plus group was 2.0 (1.6) days (median, 1 [range, 1-8] day; 95% CI, 1.64-2.28 days); in the EM group, 3.3 (3.6) days (median, 2 [range, 1-20] days; 95% CI, 2.62-4.06 days) (P = .01; α = .05, 2-tailed Mann-Whitney test). For the secondary end point (effect of a single maneuver), no significant difference was detected (67 of 98 [68.4%] vs 61 of 97 [62.9%]; P = .42; α = .05). No serious adverse event was detected with both maneuvers. Nineteen patients (19.6%) in the EM group and 24 (24.5%) in the SM-plus group experienced relevant nausea. Conclusions and Relevance: The SM-plus self-maneuver is superior to the EM self-maneuver in terms of the number of days until recovery in pcBPPV. Trial Registration: ClinicalTrials.gov Identifier: NCT05853328.

From sleep duration to childhood obesity--what are the pathways?

UNLABELLED: Sleep duration has been identified as risk factor for obesity already in children. Besides investigating the role of fat mass (FM), this study addressed the question whether endocrine mechanisms act as intermediates in the association between sleep duration and overweight/obesity. Within the framework of the IDEFICS study, the present research was conducted in 609 German resident children aged 2-9 years with information on fasting insulin, C-reactive protein and cortisol levels next to anthropometric measurements and parental questionnaires. Emphasising methodological aspects, an age-specific measure of sleep duration was derived to account for alteration in sleep duration during childhood/period of growth. Multivariate linear regression and quantile regression models confirmed an inverse relationship between sleep duration and measures of overweight/obesity. The estimate for the association of sleep duration and body mass index (BMI) was approximately halved after adjustment for FM, but remained significant. The strength of this association was also markedly attenuated when adjusting for insulin mainly for the upper BMI quantiles (Q80, ß = -0.36 vs. ß = -0.26; Q95, ß = -0.87 vs. ß = -0.47). Adjustment for cortisol and CrP did not yield this attenuation. CONCLUSION: The inverse relationship between sleep duration and BMI is mainly explained by the association between sleep duration and FM. Insulin may explain part of this association, in particular at the upper tail of the BMI distribution.

Validation and extension of a simple questionnaire to assess physical activity in pre-school children.

OBJECTIVE: To (i) validate a recently proposed questionnaire tool for the simple assessment of physical activity (PA) in pre-school children by comparison with accelerometry and heart-rate recordings; and (ii) extend the tool by adding more questions to improve validity and to refine the classification from two to three categories (PA low, medium, high). SETTING: Baseline data of an intervention evaluation study. SUBJECTS: Pre-school children. DESIGN: Children were categorized as either physically active or non-active, based on their parents' answers to the five-item questionnaire. Activity and heart rate were recorded for 6 d (Actiheart device; CamNtech, Cambridge, UK). Nightly sleeping periods were removed and mean accelerometry counts (MACT), time spent in moderate-to-vigorous intensity physical activity (MVPA) and time spent in sedentary behaviour (SB) were computed. In a second step, additional questions that improved validity were added, resulting in an extended seven-item questionnaire. RESULTS: For 748 (90·4 %) of the participating children aged 2·3-6·7 years, the questionnaires were filled out sufficiently for classification. Children classified as physically active showed 9·6 % higher MACT (P < 0·0003), spent more time in MVPA and insignificantly less time in SB. Using the extended questionnaire, children with PA classified as medium (reference: low) showed 11·0 % more MACT, spent 11·8 % more time in MVPA and 4·8 % less time in SB. Children with PA classified as high showed 16·9 % more MACT, spent 20·2 % more time in MVPA and 7·2 % less time in SB. CONCLUSIONS: With validated PA questionnaires for pre-school children lacking, the proposed questionnaire might be a reasonable option to include for PA assessment in epidemiological studies where more elaborate measurements are unavailable.

BPPV: Comparison of the SémontPLUS With the Sémont Maneuver: A Prospective Randomized Trial.

Objective: To compare the efficacy of the Sémont maneuver (SM) with the new "SémontPLUS maneuver" (SM+) in patients with posterior canal BPPV canalolithiasis (pcBPPVcan). Methods and Patients: In a prospective trinational (Germany, Italy, and Belgium) randomized trial, patients with pcBPPVcan were randomly assigned to SM or SM+; SM+ means overextension of the head by 60+° below earth horizontal line during the movement of the patient toward the affected side. The first maneuver was done by the physician, and the subsequent maneuvers by the patients 9 times/day on their own. Each morning the patient documented whether vertigo could be induced. The primary endpoints were: "How long (in days) does it take until no attacks can be induced?" and "What is the efficacy of a single SM/SM+?" Results: In the 194 patients analyzed (96 SM, 98 SM+), it took 2 days (median, range 1-21 days, mean 3.6 days) for recovery with SM and 1 day (median, range 1-8 days, mean 1.8 days) with SM+ (p = 0.001, Mann-Whitney U-test). There was no difference in the second primary endpoint (chi2-test, p = 0.39). Interpretation: This prospective trial shows that SM+ is more effective than SM when repeated therapeutic maneuvers are performed but not when a single maneuver is performed. It also supports the hypothesis of the biophysical model: overextension of the head during step 2 brings the clot of otoconia beyond the vertex of the canal, which increases the effectivity. Classification of Evidence: This study provides Class I evidence that SM+ is superior to SM for multiple treatment maneuvers of pcBPPVcan.

Quality of life in adolescents with headache: results from a population-based survey.

The aim of the investigation was to study the impact of headache on quality of life (QOL) in adolescents in a population-based sample (N = 1047, aged between 13 and 17 years). QOL was assessed using the KINDL-R (Revidierter Kinder Lebensqualitätsfragebogen) questionnaire with its six dimensions. In order to assess potential differences in the impact on QOL according to the type of headache, a stratified analysis was performed. QOL differences compared to the 'no headache' group are presented with adjustment for socio-demographic confounders. Headache at least once per month was reported in 48% of the adolescents and accounted for a small but significant reduction of 2.5 points in the total KINDL-R score, which was mainly caused by a reduction in physical wellbeing by 6.8 points. Adolescents with migraine reported higher reductions in physical wellbeing and total QOL than subjects with tension-type headache (TTH). The size of the reduction in QOL scores was small but similar to that observed for other chronic conditions in adolescents. Headache prevention programs might therefore have an impact on QOL in adolescents.

Diagnostic indices for vertiginous diseases.

BACKGROUND: Vertigo and dizziness are symptoms which are reported frequently in clinical practice. We aimed to develop diagnostic indices for four prevalent vertiginous diseases: benign paroxysmal positional vertigo (BPPV), Menière's disease (MD), vestibular migraine (VM), and phobic postural vertigo (PPV). METHODS: Based on a detailed questionnaire handed out to consecutive patients presenting for the first time in our dizziness clinic we preselected a set of seven questions with desirable diagnostic properties when compared with the final diagnosis after medical workup. Using exact logistic regression analysis diagnostic scores, each comprising of four to six items that can simply be added up, were built for each of the four diagnoses. RESULTS: Of 193 patients 131 questionnaires were left after excluding those with missing consent or data. Applying the suggested cut-off points, sensitivity and specificity were 87.5 and 93.5% for BPPV, 100 and 87.4% for MD, 92.3 and 83.7% for VM, 73.7 and 84.1% for PPV, respectively. By changing the cut-off points sensitivity and specificity can be adjusted to meet diagnostic needs. CONCLUSIONS: The diagnostic indices showed promising diagnostic properties. Once further validated, they could provide an ease to use and yet flexible tool for screening vertigo in clinical practice and epidemiological research.

Sleep duration and obesity in children: is the association dependent on age and choice of the outcome parameter?

STUDY OBJECTIVES: To assess the association between sleep duration in children and different markers of body fat by age and weight status. DESIGN: Nation-wide health survey. Measurement of BMI and body fat percentage (KFA) calculated from weight, height, skin fold thickness, age, and sex. Sleep duration and potential confounding variables were assessed in a parent questionnaire. SETTING: N/A. PARTICIPANTS: 7767 German resident children from 3 to 10 years of age. INTERVENTIONS: N/A. MEASUREMENTS AND RESULTS: Prolongation of sleep duration from the lowest to the highest percentile accounted for a similar mean decrease founding variables and did not show a systematic age dependency. The greatest effects of sleep duration were seen for the upper tails of the BMI and KFA distributions, which were about four as high as the lower tails. CONCLUSIONS: The association between sleep duration and weight status is of similar size through ages 3 to 10 years. The sleep-associated changes in BMI are likely to be a consequence of higher body fat and primarily affect children whose BMI or KFA is already elevated. These findings favor hormonal pathways nurturing adipose tissue playing a key role in the underlying physiological mechanisms.

Co-morbidities of vertiginous diseases.

BACKGROUND: Co-morbidities of vertiginous diseases have so far not been investigated systematically. Thus, it is still unclear whether the different vertigo syndromes (e.g. benign paroxysmal positional vertigo (BPPV), Meniere's disease (MD), vestibular migraine and phobic vertigo (PPV)) have also different spectrums of co-morbidities. METHODS: All patients from a cohort of 131 participants were surveyed using a standardised questionnaire about the co-morbidities hypertension, diabetes mellitus, BMI (body mass index), migraine, other headache, and psychiatric diseases in general and the likelihood of a depression in particular. RESULTS: We noted hypertension in 29.0% of the cohort, diabetes mellitus in 6.1%, migraine in 8.4%, other headache in 32.1%, psychiatric diseases in 16.0%, overweight and obesity in 33.6% and 13.7% respectively, as well as a clinical indication for depression in 15.9%. CONCLUSION: In general, we did not detect an increased prevalence of the co-morbidities diabetes mellitus, arterial hypertension, migraine, other headache and obesity compared to the general population. There was an increased prevalence of psychiatric co-morbidity in patients with PPV, and the prevalence of hypertension was elevated in patients with MD.

A simple assessment of physical activity is associated with obesity and motor fitness in pre-school children.

OBJECTIVE: Physical activity is an important determinant of energy balance. However, its impact on overweight/obesity has proved difficult to measure in pre-school children and few studies have found significant associations. A set of simple questions was used to distinguish pre-school children with high and low physical activity, and the association of this classification with childhood overweight/obesity and performance in an established motor test was investigated. DESIGN: Survey, cross-sectional. SETTING AND SUBJECTS: Weight and height were measured in 12,556 children taking part in the obligatory school entrance health examination 2004-5 and 2005-6 in three urban and three rural Bavarian regions. Their parents were asked to answer a questionnaire with a set of questions on physical activity. RESULTS: The mean age of the children evaluated was 5.78 (sd 0.43) years, 6535 (52.1 %) were boys. Physically active children were less likely to be overweight (OR = 0.786, 95 % CI 0.687, 0.898) or obese (OR = 0.655, 95 % CI 0.506, 0.849) and achieved 6.7 (95 % CI 5.8, 7.7) % more jumps per 30 s than less active children in a motor test, adjusted for a number of potentially confounding variables. CONCLUSIONS: Classification of pre-school children as physically active or not, based on a small set of questions, revealed significant associations with overweight/obesity and a motor test. Once further validated, this classification might provide a valuable tool to assess the impact of physical activity on the risk of childhood overweight and obesity.

Results and lessons learnt from a randomized controlled trial: prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG).

BACKGROUND: Vestibular migraine (VM) is the most frequent cause of recurrent spontaneous attacks of vertigo causally related to migraine. The objective of the Prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG) trial was to demonstrate that metoprolol succinate is superior to placebo in the prevention of episodic vertigo- and migraine-related symptoms in patients with VM. METHODS: This phase III, two-arm, parallel-group, double-blind, randomized placebo-controlled trial was designed to be conducted at tertiary referral centres at neurology and ear, nose and throat departments of eight German university hospitals. The planned sample size was a total of 266 patients to be allocated. Adults aged 18 years or above diagnosed with probable or definitive VM according to the Neuhauser criteria 2001 were randomly assigned 1:1 to 6 months blinded metoprolol (maintenance dosage of 95 mg daily) or placebo. The primary efficacy outcome was the self-reported number of vertiginous attacks per 30 days documented by means of a paper-based daily symptom diary. The pre-specified time period of primary interest was defined as months 4 to 6. Secondary outcomes included the patient-reported number of migraine days and vertigo days, the Dizziness Handicap Inventory, and clinical assessments. Adverse events were reported throughout the whole 9-month study period. RESULTS: At the time of trial termination, no evidence for a difference in the incidence of vertiginous attacks between groups was detected. For the full analysis set, the incidence rate ratio was 0.983 (95% confidence interval (CI) 0.902-1.071) for metoprolol versus placebo. In both groups, there was a significant decline over time in the overall monthly vertigo attacks by a factor of 0.830 (95% CI 0.776-0.887). Results were consistent for all subjective and objective key measures of efficacy. The treatment was well tolerated with no unexpected safety findings. CONCLUSIONS: After randomizing 130 patients PROVEMIG had to be discontinued because of poor participant accrual not related to the tolerability of the study medication or safety concerns; no treatment benefit of metoprolol over placebo could be established. Additional preparatory work is much needed in the development, psychometric evaluation and interpretation of clinically meaningful end points in trials on episodic syndromes like VM taking into consideration the complexity of this disease entity comprising two domains (vertigo- and headache-related disability). TRIAL REGISTRATION: EudraCT, 2009-013701-34. Prospectively registered on 8 April 2011.

A randomized double-blind, placebo-controlled, cross-over trial (Vestparoxy) of the treatment of vestibular paroxysmia with oxcarbazepine.

OBJECTIVE: Vestibular paroxysmia (VP) is characterized by short, often oligosymptomatic attacks of vertigo which occur spontaneously or are sometimes provoked by turning the head. Despite the description of the disease almost 40 years ago (first termed "disabling positional vertigo"), no controlled treatment trial has been published to date. The Vestparoxy trial was designed as a randomized, placebo-controlled, double-blind cross-over trial to examine the therapeutic effect of oxcarbazepine (OXA) in patients with definite or probable VP. METHODS: Patients were recruited from August 2005 to December 2011 in the outpatient Dizziness Unit of the Department of Neurology of the Munich University Hospital, and randomized to receive OXA (first week: 300 mg once per day, second week: 300 mg b.i.d., third week: 300 mg t.i.d. until the end of the third month), followed by placebo or vice versa with a 1-month wash-out period in between. The primary endpoint was the number of days with one or more attacks. Secondary endpoints were the number of attacks during the observed days, and the median (for each day) duration of attacks. All these endpoints were assessed using standardized diaries collected at the end of each treatment phase. RESULTS: Forty-three patients were randomized, 18 patients provided usable data (2525 patient days) for at least one treatment phase and were included in the main (intention-to-treat) analysis. The most common reasons for discontinuation documented were adverse events. The risk of experiencing a day with at least one attack was 0.41 under OXA, and 0.62 under placebo treatment, yielding a relative risk of 0.67 (95% CI 0.47-0.95, p = 0.025). The number of attacks during the observed days ratio was 0.53 (95% CI 0.42-0.68, p < 0.001) under OXA compared to placebo. Median attack duration was 4 s (Q25: 2 s, Q75: 120 s) under OXA, and 3 s (Q25: 2 s, Q75: 60 s) under placebo treatment. When days with no attacks, i.e., duration = 0, were included in the analysis, these figures changed to 0 (Q25: 0, Q75: 3 s), and 2 (Q25: 0, Q75: 6 s). No serious adverse events or new safety findings were identified during the trial. CONCLUSIONS: The Vestparoxy trial showed a significant reduction of VP attacks under OXA compared to placebo treatment, confirming the known and revealing no new side effects.

Comparison of the Bedside Head-Impulse Test with the Video Head-Impulse Test in a Clinical Practice Setting: A Prospective Study of 500 Outpatients.

OBJECTIVES: The primary aim was to determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the bedside head-impulse test (bHIT) using the video HIT (vHIT) as the gold standard for quantifying the function of the vestibulo-ocular reflex (VOR). Secondary aims were to determine the bHIT inter-rater reliability and sensitivity in detecting unilateral and bilateral vestibulopathy. METHODS: In this prospective study, 500 consecutive outpatients presenting to a tertiary neuro-otology clinic with vertigo or dizziness of various vestibular etiologies who did not have any of the pre-defined exclusion criteria were recruited. Bedside HITs were done by three experienced neuro-otology clinicians masked to the diagnosis, and the results were compared with the vHIT. The patients were likewise blinded to the bHIT and vHIT findings. Patients with VOR deficits were identified on the vHIT by referencing to the pre-selected "pathological" gain of <0.7. The data were then analyzed using standard statistical methods. RESULTS: For the primary outcome (vHIT "pathological" VOR gain <0.7), the three-rater mean bHIT sensitivity = 66.0%, PPV = 44.3%, specificity = 86.2%, and NPV = 93.9%. Shifting the "pathological" threshold from 0.6 to 0.9 caused the bHIT sensitivity to decrease while the PPV increased. Specificity and NPV tended to remain stable. Inter-rater agreement was moderate (Krippendorff's alpha = 0.54). For unilateral vestibulopathy, overall bHIT sensitivity = 69.6%, reaching 86.67% for severely reduced unilateral gain. For VOR asymmetry <40% and >40%, the bHIT sensitivity = 51.7 and 83%, respectively. For bilateral vestibulopathy, overall bHIT sensitivity = 66.3%, reaching 86.84% for severely reduced bidirectional gains. CONCLUSION: For the primary outcome, the bHIT had moderate sensitivity and low PPV. While the study did not elucidate the best choice for vHIT reference, it demonstrated how the bHIT test properties varied with vHIT thresholds: selecting a lower threshold improved the sensitivity but diminished the PPV, while a higher threshold had the opposite effect. The VOR was most likely normal if the bHIT was negative due to its high NPV. The bHIT was moderately sensitive for detecting unilateral and bilateral vestibulopathy overall, but better for certain subgroups.

Clinical evaluation of the bed cycling test.

OBJECTIVE: Additionally to the forearm rolling test to detect mild unilateral upper limb dysfunction, the bed cycling test (BCT) for detection of mild to moderate lower limb dysfunction was developed, evaluated and compared to the leg holding test. METHODS: In a prospective observer-blinded study, 60 patients with MRI/CT-proven focal cerebral hemisphere lesions and a mild to moderate unilateral paresis of the lower limb (graduated MRC 3-4/5), and 60 control persons with normal imaging were examined and filmed. Nine observers blinded to the diagnosis evaluated these videos. The sensitivity, specificity and the positive and negative predictive values of the clinical tests were analyzed. RESULTS: The observers gave a correct evaluation of BCT in 35.5% of all patients with focal cerebral lesions compared to 26.0% for the leg holding test. On the other hand, observers had false negative results in 29.1% of cases with BCT and 44.7% with leg holding test. In 36.7% of patients, only BCT was pathological while leg holding test was unremarkable. The sensitivity of the combination of both tests was 0.68 (95% CI 0.61-0.75). The BCT is more sensitive (64.3%) than leg holding test (46.2%) while the specificity of leg holding test (85.6%) is higher than of BCT (70.1%) to detect a cerebral lesion affecting the lower limb. The inter-rater variability is high with no differences comparing different types of clinical experience. CONCLUSIONS: The BCT is a useful additional clinical bedside test to detect subtle unilateral cerebral lesions. The BCT is easy to perform and can be added to the routine neurological examination.

The takeaway Frenzel goggles: a Fresnel-based device.

OBJECTIVE: To develop and evaluate new thin and light glasses for the examination of patients with nystagmus and to compare them with Frenzel goggles. METHODS: First, we designed new examination glasses: a Fresnel-based device with a short focal length that is not as heavy or bulky as Frenzel goggles. Second, visual-fixation suppression of postrotatory nystagmus with Frenzel goggles and the Fresnel-based device, the latter with 2 different magnifications (2- and 4-fold), was compared in 13 healthy subjects. Third, the intensity of the peripheral vestibular spontaneous nystagmus-in 6 patients with acute vestibular neuritis-with the Frenzel goggles and the Fresnel-based device with the 4-fold magnification was compared. Fourth, the visibility and clinical applicability were evaluated. RESULTS: The Fresnel-based device weighs 6 g (dimensions 12 × 8 × 0.3 cm). There was no significant difference in the intensity of postrotatory nystagmus between the Fresnel-based device with 4-fold magnification (37.3 ± 17.9°/s) and the Frenzel goggles (39.0 ± 18.3°/s). There was also no significant difference between the intensity of peripheral vestibular spontaneous nystagmus in the patients with acute vestibular neuritis. The Fresnel-based device can be easily applied. CONCLUSION: For suppression of nystagmus, the new Fresnel-based device or so-called M glasses is not inferior to Frenzel goggles. Doctors can carry it in their pocket, it is inexpensive, and easy to handle and to fix to the patient's nose so that it can be used in daily practice for the bedside examination. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that, in subjects with nystagmus, a Fresnel-based device identifies a similar intensity of nystagmus as that identified by Frenzel goggles.