Motor Point as an Alternative to Femoral Nerve Stimulation for the Assessment of Quadriceps Muscle Inhibition in Healthy Women.

CONTEXT: The evaluation of quadriceps muscle inhibition with the interpolated twitch technique is usually performed by stimulating the femoral nerve (FN). However, there are some problems related to the use of this stimulation site, which may be partially overcome by delivering the stimulation over the motor point (MP). This study sought to compare MP to FN stimulation at different joint angles for the evaluation of quadriceps muscle inhibition, resting peak torque, and discomfort in healthy women. DESIGN: Cross-sectional study. METHODS: Sixteen healthy women (age: 28 [4] y; body mass: 60 [5] kg; height: 162 [5] cm) participated in this study. Supramaximal paired stimuli were delivered to the FN and to the rectus femoris MP before and during maximal voluntary contractions at different knee angles (15°, 30°, 45°, 60°, and 90° of knee flexion) to assess muscle inhibition and resting peak torque. Discomfort was also recorded for each stimulation site and knee angle. RESULTS: Muscle inhibition was similar between the 2 stimulation sites (P > .05) and was higher at 45° than at 90° (P = .03). MP stimulation evoked lower resting peak torque at 30° (P = .004), 60° (P = .006), and 90° (P = .006) and higher discomfort at 30° (P = .008) and 90° (P = .027) compared to FN stimulation. CONCLUSIONS: Despite lower resting peak torque and higher discomfort at some angles, MP stimulation provided similar muscle inhibition to FN stimulation at all knee angles and is therefore a valid method to evaluate quadriceps muscle inhibition in healthy women. MP stimulation can be used as an alternative to FN stimulation for the evaluation of quadriceps muscle inhibition with no added discomfort at the angles where muscle inhibition is the highest.

In Vivo Evaluation of Laser-Induced Optical Breakdown (LIOBS) by 1064-nm Nd:YAG Fractional Picosecond Laser With Reflectance Confocal Microscopy and Precise Histopathologic Correlation.

OBJECTIVES: Picosecond lasers with a microlens array can cause laser-induced optical breakdown (LIOBS) and LIC (Intradermal laser-induced cavitation) within high-fluence areas. This study aimed to describe the clinical, reflectance confocal microscopy (RCM), histopathological findings, and the characteristics of vacuoles caused by LIOBS and LIC in individuals with skin types III and IV. MATERIALS AND METHODS: This study was performed on six Chilean healthy volunteers, males and females, aged 35-65 years old with Fitzpatrick skin phototypes III-IV. The laser was applied in the inner proximal area of the nondominant arm. RCM evaluation was performed 24 h later; 48 h later, skin biopsies were performed on the laser-treated areas. Clinical, histological, and RCM findings were recorded. RESULTS: Every individual developed a 10 mm2 area of clinical erythema in the treated area. Under RCM, all six volunteers had hyporeflective spherical structures at the level of the epidermis, consistent with intraepidermal vacuoles. Histopathological evaluation revealed different sizes of vacuoles in both the epidermis and dermis. CONCLUSION: The LIOBS and LIC processes and the secondary production of vacuoles could be highly valuable for effective dermal remodeling treatment and aid in promoting the production of new collagen, elastic fibers, and growth factors that could improve skin texture. These structures were visible under RCM and histopathological evaluation.

Anconeus and pronation: a palpatory and ultrasonographic study.

PURPOSE: Depending on its axis, pronation varies from the radius rotation around the steady ulna to the reciprocal adduction of the radius and abduction of the ulna. While there is no question that pronator teres is a central pronation agonist, anconeus's role is not settled. The current investigation comparing palpation and ultrasonography in these two muscles during pronation along the axis capitulum-second digit evolved from a serendipitous finding in a clinical anatomy seminar. METHODS: Single-hand palpation and two-transducer ultrasonography over anconeus and pronator teres were used on ten normal subjects to investigate their contraction during pronation around the capitulum-second digit axis. These studies were done independently and blind to the results of the other. The statistical analysis between palpation and ultrasonography was performed with Cohen's kappa coefficient and the χ2 test. RESULTS: On palpation, on resisted full pronation, anconeus contracted in 8/10 subjects and pronator teres in 10/10 subjects. Without resistance, the corresponding ratios were 5/10 and 9/10. On two-transducer ultrasonography, the comparable ratios were 7/10 and 10/10, and 3/10 and 10/10. A fair concordance (Cohen's kappa = 0.21) between palpation and ultrasonography in detecting the simultaneous status of anconeus and pronator teres during resisted full pronation. Anatomic dissection illustrated the elements involved. CONCLUSIONS: Plain palpation confirmed by ultrasonography showed the simultaneous contraction of anconeus and pronator teres during resisted pronation in most of the studied subjects. The study suggests that palpation can be helpful in directly studying muscle activity during movement.

Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans.

Myocardial reperfusion injury (MRI) accounts for up to 50% of the final size in acute myocardial infarction and other conditions associated with ischemia-reperfusion. Currently, there is still no therapy to prevent MRI, but it is well known that oxidative stress has a key role in its mechanism. We previously reduced MRI in rats through a combined antioxidant therapy (CAT) of ascorbic acid, N-acetylcysteine, and deferoxamine. This study determines the safety and pharmacokinetics of CAT in a Phase I clinical trial. Healthy subjects (n = 18) were randomized 2:1 to CAT or placebo (NaCl 0.9% i.v.). Two different doses/infusion rates of CATs were tested in a single 90-minute intravenous infusion. Blood samples were collected at specific times for 180 minutes to measure plasma drug concentrations (ascorbic acid, N-acetylcysteine, and deferoxamine) and oxidative stress biomarkers. Adverse events were registered during infusion and followed for 30 days. Both CAT1 and CAT2 significantly increased the CAT drug concentrations compared to placebo (P < .05). Most of the pharmacokinetic parameters were similar between CAT1 and CAT2. In total, 6 adverse events were reported, all nonserious and observed in CAT1. The ferric-reducing ability of plasma (an antioxidant biomarker) increased in both CAT groups compared to placebo (P < .001). The CAT is safe in humans and a potential treatment for patients with acute myocardial infarction undergoing reperfusion therapy.

Acute Effect of Transcranial Direct Current Stimulation in Pelvic Floor Muscle Function in Young Healthy Women: Initial Findings of a Randomized Controlled Trial.

INTRODUCTION AND HYPOTHESIS: Transcranial direct current stimulation (tDCS) can enhance muscle function in healthy individuals. However, it is unknown if tDCS associated with pelvic floor muscle training (PFMT) can improve pelvic floor muscle function (PFMF) in healthy women. The aim of this study was to investigate the acute effect of a single session of tDCS in PFMF compared with sham-tDCS in healthy women. METHODS: A double-blind, cross-over, randomized clinical trial was conducted with healthy, nulliparous and sexually active women. PFMF was assessed by bidigital palpation (PERFECT scale) and intravaginal pressure by a manometer (Peritron™). Participants randomly underwent two tDCS sessions (active and sham) 7 days apart. The electrode was positioned equal for both protocols, the anode electrode in the supplementary motor area (M1) and the cathode electrode in the right supraorbital frontal cortex (Fp2). The current was applied for 20 min at 2 mA in active stimulation and for 30 s in sham-tDCS. The tDCS applications were associated with verbal instructions to PFMT in a seated position. After each tDCS session PFMF was reevaluated. RESULTS: Twenty young healthy women (aged 23.4 ± 1.7 years; body mass index 21.7 ± 2.2 kg/m2) were included. No difference was observed in power, endurance, and intravaginal pressure of PFMF (p > 0.05). The number of sustained contractions improved from 3.0 (2.0-3.5) to 4.0 (3.0-5.0) after active-tDCS (p = 0.0004) and was superior to sham-tDCS (p = 0.01). CONCLUSION: The number of sustained contractions of PFM improved immediately after a single active-tDCS session, with a difference compared with the post-intervention result of sham-tDCS in healthy young women.

ABCG2 polymorphism and rivaroxaban pharmacokinetics in healthy individuals after a single dose.

Rivaroxaban is a direct factor Xa inhibitor. Its interindividual variability is large and may be connected to the occurrence of adverse drug reactions or drug inefficacy. Pharmacogenetics studies concentrating on the reasons underlying rivaroxaban's inadequate response could help explain the differences in treatment results and medication safety profiles. Against this background, this study evaluated whether polymorphisms in the gene encoding the ABCG2 transporter modify the pharmacokinetic characteristics of rivaroxaban. A total of 117 healthy volunteers participated in two bioequivalence experiments with a single oral dose of 20 mg rivaroxaban, with one group fasting and the other being fed. Ultra-high-performance liquid chromatography coupled with mass spectrometry was employed to determine the plasma concentrations of rivaroxaban, and the WinNonlin program was used to calculate the pharmacokinetics parameters. In the fasting group, the rivaroxaban pharmacokinetic parameters of Vd (508.27 vs 334.45 vs 275.59 L) and t1/2 (41.04 vs 16.43 vs 15.47 h) were significantly higher in ABCG2 421 A/A genotype carriers than in ABCG2 421 C/C and 421 C/A genotype carriers (P<0.05). The mean values of Cmax (145.81 vs 176.27 vs 190.19 ng/mL), AUC0-t (1193.81 vs 1374.69 vs 1570.77 ng/mL·h), and Cl (11.82 vs 14.50 vs 13.01 mL/h) for these groups were lower, but this difference was not statistically significant (P>0.05). These findings suggested that the ABCG2 421 A/A genotype may impact rivaroxaban parameters after a single dose in healthy subjects. This finding must be validated before it is applied in clinical practice.

Pharmacokinetic Profile and Comparative Bioavailability of an Oral Fixed-Dose Combination of Metformin and Acetylsalicylic Acid (Aspirin).

Patients with diabetes face a 2-4-fold greater cardiovascular risk compared to those without diabetes. Both metformin and acetylsalicylic acid (aspirin) treatment have demonstrated a significant reduction in this risk. This single-center, open-label, sequence randomized, 2 × 2 crossover, single-dose clinical trial evaluated the pharmacokinetics profile and comparative bioavailability of a novel oral fixed-dose combination (FDC) of metformin/acetylsalicylic acid (500/100 mg tablet) versus the reference mono-drugs administered concomitantly, metformin 500 mg tablet and acetylsalicylic acid 100 mg tablet, in 22 healthy Mexican adult volunteers under fasting conditions. Blood samples were collected predose and at specified intervals across a 24-hour period following administration and were analyzed for metformin and salicylic acid using high-performance liquid chromatography coupled with tandem mass spectrometry. Test products were considered to have comparative bioavailability if confidence intervals of natural log-transformed (maximum plasma drug concentration (Cmax), (area under the plasma drug concentration-time curve form 0 up to last sampling time (AUC0 -t), and (area under the plasma drug concentration-time cruve from 0 up to infinity (AUC0 ∞) data were within the range of 80%-125%. The results obtained from the present clinical study demonstrate the comparative bioavailability of the FDC when compared with the coadministration of reference mono-drugs. There were no adverse events or adverse reactions reported throughout the study.

Comparative Bioavailability of a Novel Fixed-dose Combination Etoricoxib and Tramadol.

Multimodal analgesia is defined as using several drugs or techniques simultaneously to target different pain pathways or receptors to avoid pain propagation. This study evaluated the pharmacokinetic profile and comparative bioavailability of etoricoxib 90 mg and tramadol 50 mg dosing alone (reference drugs) or in a novel fixed-dose combination (test drug) under fasting conditions in Mexican healthy volunteers. This was a randomized, open-label, 3-way, crossover, single-dose, prospective, and longitudinal study with a 14-day washout period. Eligible subjects were healthy Mexican adult volunteers. The drugs were dosing orally, according to the randomization sequence, after 10 hours of fasting and 4 hours before breakfast with 250 mL of water at room temperature. Serial blood samples were collected before and after dosing, both drugs were quantified using high-performance liquid chromatography coupled with tandem mass spectrometry. Forty-two subjects were enrolled and 38 completed the study (28 men and 14 women, mean age 25.2 years, mean weight 66.6 kg). Test products were considered to have comparative bioavailability if confidence intervals of natural log-transformed for (maximum plasma drug concentration (Cmax), (area under the plasma drug concentration-time curve form 0 up to last sampling time (AUC0-t), and (area under the plasma drug concentration-time curve from 0 up to infinity (AUC0-∞) data were within the range of 80%-125%. Non-serious adverse events were observed. The results demonstrate that the pharmacokinetic profile and bioavailability of the etoricoxib/tramadol fixed-dose combination are comparable to those of the reference products.

Screen Time and Hours of Sleep Influence the Estimate Risk of Diabetes Mellitus and Metabolic Syndrome in Healthy Young Males.

Objective: Screen time (ST) has shown negative effects on physical and mental health, with an increase in the prevalence of overweight, metabolic syndrome (MetS), and obesity. The time spent in front of the screens was also associated with higher odds of selecting indicators of cardiometabolic disease in adulthood. In view of this, the aim of this study was to identify the risk of MetS and type 2 diabetes mellitus (T2DM) in healthy young males and relate it to ST and sleep time. Methods: We evaluated physical and laboratory characteristics, dichotomous diagnosis criteria, and continuous scores to assess MetS and Finnish Diabetes Risk Score questionnaire to measure the T2DM risk. Results: The means of MetS dichotomous and continuous severity criteria, among individuals with <7 hr of sleep, were higher than those with adequate sleep. We did not observe a direct impact of ST on the risk of MetS; nevertheless, >8 hr of ST increased 1.22 points in the T2DM risk. Conclusion: Excessive ST increased the risk of T2DM, but not of MetS. Moreover, sleeping <7 hr was associated with a higher mean of dichotomous and continuous severity criteria for MetS.

Can Diet Alter the Intestinal Barrier Permeability in Healthy People? A Systematic Review.

Dietary factors can modify the function of the intestinal barrier, causing permeability changes. This systematic review analyzed evidence on the link between diet or dietary interventions and changes in intestinal barrier permeability (IBP) in healthy individuals. A systematic search for primary studies was conducted using the virtual databases EMBASE, PubMed, Web of Science, CINAHL, and Scopus. This review adhered to PRISMA 2020 guidelines, assessing the methodological quality using the Newcastle-Ottawa scale for observational studies and ROB 2.0 for randomized clinical trials. Out of 3725 studies recovered, 12 were eligible for review. Chicory inulin and probiotics reduced IBP in adults with a moderate GRADE level of evidence. The opposite result was obtained with fructose, which increased IBP in adults, with a very low GRADE level of evidence. Only intervention studies with different dietary components were found, and few studies evaluated the effect of specific diets on the IBP. Thus, there was no strong evidence that diet or dietary interventions increase or decrease IBP in healthy individuals. Studies on this topic are necessary, with a low risk of bias and good quality of evidence generated, as there is still little knowledge on healthy populations.

Evaluating Dielectric Properties for Assessing Water Content at Acupuncture Points: New Methodology.

Importance: Understanding acupuncture point microenvironments is vital for optimizing treatment efficacy. Evaluating changes in water content at these points can provide further insights into the effects of acupuncture on tissues. Objective: This study aimed to measure tissue dielectric constant (TDC) and assess changes in water content, specifically at stomach 36 (ST36, Zusanli) and spleen 6 (SP6, Sanyinjiao) acupuncture points. Methods: In a controlled, blinded, randomized trial, 113 healthy volunteers were divided into six groups based on TDC sensor diameters (XS, M, and L): three control groups and three acupuncture groups. They were assessed at three time points: T1, baseline; T2, 20 min post-needle withdrawal; and T3, 40 min post-needle withdrawal. Electrical impedance (EI) was also analyzed. Significance level was set at p < 0.001. Results: TDC at ST36 and SP6 significantly decreased with the XS probe at T2 and T3 compared with that at T1 (F8, 452: 54.61). TDC did not significantly vary between T2 and T3 with M and L probes. EI data indicated that the current passage increased in the SP (F2, 226: 39.32) and ST (F2, 226: 37.32) groups during T2 and T3 compared with that during T1 within their respective groups and controls. Conclusions: and Relevance: This study demonstrated the efficacy of TDC measurements in detecting water content fluctuations at acupuncture points and their responses to needles. TDC measurements, which were validated against EI, provide valuable insights into acupuncture point microenvironments and thus help optimize treatments.

Model-Based Bioequivalence Analysis to Assess and Predict the Relative Bioavailability of Valproic Acid Formulations.

BACKGROUND AND OBJECTIVE: Model-based bioequivalence (MBBE) encompasses the use of nonlinear mixed effect models supporting the estimation of pharmacokinetic endpoints to assess the relative bioavailability between multi-source drug products. This application emerges as a valuable alternative to the standard non-compartmental analysis (NCA) in bioequivalence (BE) studies in which dense sampling is not possible. In this work, we aimed to assess the application of MBBE compared to traditional methods in evaluating the relative bioavailability of two formulations with different drug release properties. Additionally, we sought to predict the performance of a modified-release formulation in a multiple-dose scenario, leveraging data from a single-dose study. METHODS: MBBE analysis was implemented to estimate the BE endpoints (90% CI for the Test/Reference geometric mean ratio, T/R GMR) in area under the concentration-time curve (AUC) and maximum concentration (Cmax) using data from a single-dose, 2-period, 2-sequence BE study performed in 14 healthy subjects between a locally developed valproic acid extended-release formulation (Test) and the brand-name delayed-release formulation (Reference). RESULTS: Results were compared with the standard approach, revealing that MBBE analysis achieved higher discrimination between formulations for Cmax, addressing limitations of the experimental sampling design and highlighting an advantage for this model-based analysis even when rich data are available. Additionally, the bioequivalence outcome under the multiple-dose scenario was predicted through a simulation-based study for both total and unbound valproic acid concentrations, considering the impact of valproic acid saturable binding on BE conclusions. CONCLUSIONS: The MBBE analysis was superior to the NCA approach in detecting product-related differences, overcoming limitations in the study experimental design. Predictions for the multiple-dose scenario preclude that the extended-release properties of the Test formulation would persist at steady state, resulting in lower peak-to-trough fluctuation and bioequivalent performance in terms of the extent of drug absorption. Overall, these results should discourage unnecessary experimentation in healthy subjects.

Lumbar multifidus layers stiffness at L5-S1 level in prone and sitting posture measured by shear wave elastography.

BACKGROUND: Multifidus is an important lumbar muscle with distinct superficial and deep fibers responsible for torque production and stabilization, respectively. Its mechanical properties change when transitioning from lying to sitting positions, necessitating enhanced stability. It holds crucial clinical relevance to assess these layers separately, especially in the sitting posture, which demands increased neuromuscular control compared to the prone position. OBJECTIVE: To compare lumbar multifidus stiffness in lying versus sitting postures, analyzing both superficial and deep layers. METHODS: Supersonic Shear Imaging captured elastographic images from 26 asymptomatic volunteers in prone and seated positions. RESULTS: Left multifidus shear modulus in lying: 5.98 ± 1.80/7.96 ± 1.59 kPa (deep/superficial) and sitting: 12.58 ± 4.22/16.04 ± 6.65 kPa. Right side lying: 6.08 ± 1.97/7.80 ± 1.76 kPa and sitting: 13.25 ± 4.61/17.95 ± 7.12 kPa. No side differences (lying p= 0.99, sitting p= 0.43). However, significant inter-postural differences occurred. CONCLUSION: Lumbar multifidus exhibits increased stiffness in sitting, both layers affected, with superior stiffness in superficial versus deep fibers. Applying these findings could enhance assessing multifidus stiffness changes, for classifying tension-induced low back pain stages.

Multivariate curve resolution-based data fusion approaches applied in 1H NMR metabolomic analysis of healthy cohorts.

BACKGROUND: Metabolomics plays a critical role in deciphering metabolic alterations within individuals, demanding the use of sophisticated analytical methodologies to navigate its intricate complexity. While many studies focus on single biofluid types, simultaneous analysis of multiple matrices enhances understanding of complex biological mechanisms. Consequently, the development of data fusion methods enabling multiblock analysis becomes essential for comprehensive insights into metabolic dynamics. RESULTS: This study introduces a novel guideline for jointly analyzing diverse metabolomic datasets (serum, urine, metadata) with a focus on metabolic differences between groups within a healthy cohort. The guideline presents two fusion strategies, 'Low-Level data fusion' (LLDF) and 'Mid-Level data fusion' (MLDF), employing a sequential application of Multivariate Curve Resolution with Alternating Least Squares (MCR-ALS), linking the outcomes of successive analyses. MCR-ALS is a versatile method for analyzing mixed data, adaptable at various stages of data processing-encompassing resonance integration, data compression, and exploratory analysis. The LLDF and MLDF strategies were applied to 1H NMR spectral data extracted from urine and serum samples, coupled with biochemical metadata sourced from 145 healthy volunteers. SIGNIFICANCE: Both methodologies effectively integrated and analysed multiblock datasets, unveiling the inherent data structure and variables associated with discernible factors among healthy cohorts. While both approaches successfully detected sex-related differences, the MLDF strategy uniquely revealed components linked to age. By applying this analysis, we aim to enhance the interpretation of intricate biological mechanisms and uncover variations that may not be easily discernible through individual data analysis.

Comparative analysis of pulmonary ventilation distribution between low-cost and branded incentive spirometers using electrical impedance tomography in healthy adults: Study protocol.

BACKGROUND: The Incentive Spirometer (IS) increases lung volume and improves gas exchange by visually stimulating patients to take slow, deep breaths. It prevents respiratory complications and treats postoperative atelectasis in patients undergoing abdominal, thoracic, and neurosurgical procedures. Its effectiveness has been validated in studies that support improved lung capacities and volumes in individuals with respiratory complications, postoperative thoracic surgery, upper abdominal surgery, and bariatric surgery. The modified Pachón incentive spirometer (MPIS) is a cost-effective alternative to branded IS. It is crucial to validate whether the MPIS distributes ventilation as effectively as commercial devices do. Ventilation distribution will be measured using electrical impedance tomography. OBJECTIVE: The aim is to compare the distribution of pulmonary ventilation between the MPIS and another commercial IS in healthy adults using electrical impedance tomography. METHODS: A crossover clinical trial is proposed to evaluate the measurement of pulmonary ventilation distribution using EIT in a sample of healthy adults. All participants will use a commercial flow IS and the MPIS, with the order of assignment randomized. This research will use electrical impedance tomography to validate the operation of the MPIS. CONCLUSIONS: This study protocol will compare two incentive spirometers' impact on pulmonary ventilation, potentially endorsing the adoption of a cost-effective device to enhance accessibility for targeted populations. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov (NTC05532748).

Tramadol/Diclofenac Fixed-Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product.

The multimodal analgesia strategy for acute pain involves using 2 or more analgesic medications with distinct mechanisms of action. This study assessed the bioavailability and tolerability of 2 tramadol hydrochloride (50 mg)/diclofenac sodium (50 mg) fixed-dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open-label, randomized, single-dose, 2-period, 2-way crossover trial was conducted, including healthy subjects of both sexes. Subjects received a single dose of either the test or reference formulation of tramadol/diclofenac fixed-dose combination tablets with a 7-day washout period. Blood samples were collected up to 36 hours after dosing for tramadol and 12 hours for diclofenac and quantified using a validated liquid chromatography-tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration-time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%-125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice.

Fast and accessible T2 mapping using off-resonance corrected DESPOT2 with application to 3D prostate.

PURPOSE: Most T1 and T2 mapping take long acquisitions or needs specialized sequences not widely accessible on clinical scanners. An available solution is DESPOT1/T2 (Driven equilibrium single pulse observation of T1/T2). DESPOT1/T2 uses Spoiled gradient-echo (SPGR) and balanced Steady-State Free Precession (bSSFP) sequences, offering an accessible and reliable way for 3D accelerated T1/T2 mapping. However, bSSFP is prone to off-resonance artifacts, limiting the application of DESPOT2 in regions with high susceptibility contrasts, like the prostate. Our proposal, DESPO+, employs the full bSSFP and SPGR models with a dictionary-based method to reconstruct 3D T1/T2 maps in the prostate region without off-resonance banding. METHODS: DESPO+ modifies the bSSFP acquisition of the original variable flip angle DESPOT2. DESPO+ uses variable repetition and echo times, employing a dictionary-based method of the full bSSFP and SPGR models to reconstruct T1, T2, and Proton Density (PD) simultaneously. The proposed DESPO+ method underwent testing through simulations, T1/T2 phantoms, and on fourteen healthy subjects. RESULTS: The results reveal a significant reduction in T2 map banding artifacts compared to the original DESPOT2 method. DESPO+ approach reduced T2 errors by up to seven times compared to DESPOT2 in simulations and phantom experiments. We also synthesized in-vivo T1-weighted/T2-weighted images from the acquired maps using a spin-echo model to verify the map's quality when lacking a reference. For in-vivo imaging, the synthesized images closely resemble those from the clinical MRI protocol, reducing scan time by around 50% compared to traditional spin-echo T1-weighted/T2-weighted acquisitions. CONCLUSION: DESPO+ provides an off-resonance insensitive and clinically available solution, enabling high-resolution 3D T1/T2 mapping and synthesized T1-weighted/T2-weighted images for the entire prostate, all achieved within a short scan time of 3.6 min, similar to DESPOT1/T2.

Validation of a sleep staging classification model for healthy adults based on two combinations of a single-channel EEG headband and wrist actigraphy.

STUDY OBJECTIVES: The aim of this study was to develop a sleep staging classification model capable of accurately performing on different wearable devices. METHODS: Twenty-three healthy participants underwent a full-night type I polysomnography and used two device combinations: (A) flexible single-channel electroencephalogram (EEG) headband + actigraphy (n = 12) and (B) rigid single-channel EEG headband + actigraphy (n = 11). The signals were segmented into 30-second epochs according to polysomnographic stages (scored by a board-certified sleep technologist; model ground truth) and 18 frequency and time features were extracted. The model consisted of an ensemble of bagged decision trees. Bagging refers to bootstrap aggregation to reduce overfitting and improve generalization. To evaluate the model, a training dataset under 5-fold cross-validation and an 80-20% dataset split was used. The headbands were also evaluated without the actigraphy feature. Participants also completed a usability evaluation (comfort, pain while sleeping, and sleep disturbance). RESULTS: Combination A had an F1-score of 98.4% and the flexible headband alone of 97.7% (error rate for N1: combination A = 9.8%; flexible headband alone = 15.7%). Combination B had an F1-score of 96.9% and the rigid headband alone of 95.3% (error rate for N1: combination B = 17.0%; rigid headband alone = 27.7%); in both, N1 was more confounded with N2. CONCLUSIONS: We developed an accurate sleep classification model based on a single-channel EEG device, and actigraphy was not an important feature of the model. Both headbands were found to be useful, with the rigid one being more disruptive to sleep. Future research can improve our results by applying the developed model in a population with sleep disorders. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging; URL: https://clinicaltrials.gov/study/NCT04943562; Identifier: NCT04943562. CITATION: Melo MC, Vallim JRS, Garbuio S, et al. Validation of a sleep staging classification model for healthy adults based on 2 combinations of a single-channel EEG headband and wrist actigraphy. J Clin Sleep Med. 2024;20(6):983-990.