Non-invasive Device Research Articles

Development of a near infrared region based non-invasive therapy device for diabetic peripheral neuropathy.

Diabetic Peripheral Neuropathy (DPN) is a nerve damage that is treated with painkillers and steroids which have the drawback of interference with other medications and the dangers of side effects. Novelty of the proposed work is to develop a Near Infrared Region (NIR) based non-invasive therapy device called 'DPNrelief-1.0V'developed with a 890 nm wavelength diodes. DPNrelief-1.0V delivers a total dosage of 6.174 J/cm2 with heat absorption by tissue of 61.74 Joules at 30 minutes. The device was tested by carrying out a pilot study with 8 patients where 4 were treatment group and control group. The DPNrelief-1.0V is validated by Nerve Conduction Study (NCS) test. The degenerated nerves pre-therapy showed less amplitude, Conduction Velocity (CV) and latency which was improved post-therapy by 100% in amplitude of nerve signal, 100% in CV and a decrease of 36.2% in latency. Independent t-test was conducted to find the difference between control and treatment, wherein a p value < 0.05 was obtained depicting significant difference between two groups. Furthermore, the performance of the device is validated by one-way test repeated measures Analysis of Variance (ANOVA), wherein a p value of < 0.05 was obtained depicting a difference in nerve condition pre-and post-therapy. The performance of DPNrelief-1.0V has outperformed Anodyne therapy device with lesser dosage, treatment time and portability and in curing the symptoms of DPN. DPNrelief-1.0V finds its potential in the field of medicine for treating DPN.

DNAR-03. ONCOMAGNETIC TREATMENT KILLS GLIOMA CELLS BY INHIBITING MITOCHONDRIAL ELECTRON TRANSPORT AND BY INDUCING OXIDATIVE STRESS AND DNA DAMAGE

Abstract A new noninvasive cancer therapeutic device developed in our laboratory called the Oncomagnetic device involves repeated stimulation with oscillating magnetic fields (sOMF) produced by spinning permanent magnets. It is technologically and mechanistically distinct from the Optune® device approved by the FDA and provides a novel approach for CNS tumor treatment. In 7 end-stage GBM patients, this device reversed the progression of recurrent tumors causing &amp;gt;30% reduction in their contrast-enhanced volumes within 4 – 8 weeks of treatment. Immune-competent mice with implanted mouse glioma cells in their brains also showed marked reduction in tumor size, increased survival (p&amp;lt; 0.05, n = 9) and greater DNA damage (γ-H2AX foci) in implanted tumor after sOMF treatment. Normal mice exposed to sOMF for 4 months had no adverse effects on the brain and other organs. In-vitro, sOMF inhibited mitochondrial ETC complex-I and markedly increased reactive oxygen species (ROS) levels in GBM cells. Detection of γ-H2AX and 53BP1 foci showed that sOMF caused significant DNA damage in GBM cells and diffuse intrinsic pontine glioma (DIPG) cells but not in normal astroglial SVGp12 cells. GBM cells exposed to sOMF for 4 h caused cell cycle arrest in the G1 phase and 30% - 40% loss of surviving colonies detected by clonogenic cell survival assay, while normal SVGp12 cells were not affected. This loss of survival in GBM cells was rescued by the antioxidant Trolox. These results indicate that sOMF stimulation has high anticancer potency comparable to low dose radiation therapy at the cellular level with an underlying mechanism of action that is substantially different from that proposed for Optune® TTF.

CSIG-04. ANTI-TUMOR RESPONSE OF ONCOMAGNETIC MONOTHERAPY IN GLIOBLASTOMA

Abstract BACKGROUND Glioblastoma (GBM) is the most lethal primary malignant brain tumor with a median survival of 15–20 months. Concurrent temozolomide (TMZ) chemotherapy and radiation (XRT) remain the current standard of care (SOC) treatment for newly diagnosed GBM. The addition of tumor treating fields (TTFs) improves median survival for newly diagnosed GBM from 16 to 20.9 months. This modest improvement underscores the urgent need to identify a new treatment modality as a safe and effective therapy. PURPOSE The noninvasive Oncomagnetic device developed in our laboratory selectively kills glioblastoma (GBM) in vitro. We studied the cellular and molecular effects of Oncomagnetic monotherapy (OMT) on GBM cell lines and investigated immune response in a syngeneic mouse model. RESULTS OMT significantly reduces cell proliferation and cell survival in vitro. OMT induces persistent ROS primarily by increasing superoxide level in cancer cells and reduces mitochondrial-membrane potential in GBM cells. It also induces DNA damage and arrests cells in G1-phase of the cell cycle. Whole-body Oncomagnetic stimulation caused a substantial retardation of tumor growth and reduction of the contrast-enhanced tumor volume in 9.4T MRI scans. OMT showed significant increase in overall survival in treated mice. We also observed upregulated immune response indicated by RNA sequencing data obtained from OMT-treated GBM cells as well as in treated GBM mouse tumor sections by imaging mass cytometry analysis. The tSNE analysis of various immune clusters suggests significant increase in immune response by activating CD4+, CD8+, murine-macrophages and M1-macrophages located at tumor site in the treated group. CONCLUSION The obtained data indicate significant anti-tumor response by inhibiting cancer signaling pathways and an increased immune response. Our findings suggest unique mechanism of action for OMT stimulation and provide a strong rationale for standalone OMT for GBM.

The influence of the general vibration on the quality of the assessment of the pilot's physiological indicators

The article considers flight safety issues related to continuous monitoring of the pilot's functional state by using means of monitoring physiological health indicators, which is due to the complexity of flight work, accompanied by a whole range of unfavorable factors that reduce the efficiency of professional activity. The article studies the influence of the general vibration factor on the quality (accuracy) of the assessment of the pilot's physiological indicators recorded by non-invasive diagnostic devices in transmitted light. Such indicators include heart rate, fractional blood saturation level, and respiratory rate. A mathematical model of quasi-deterministic general vibration, which is the resultant of individual frequency components of corrected vibration acceleration directed along three axes of the Cartesian coordinate system, has been developed. Mathematical modeling of the effect of general vibration on the information photoplethysmographic signal has been performed and it has been shown that the effect changes the frequency-time structure of the signal and relative errors of the estimated physiological parameters appear – the level of fractional blood saturation (4.16 %), heart rate (4.78 %) and respiration (3.75 %). As a result of a practical experiment to analyze the effect of general vibration on the quality of assessment of the specified physiological parameters, it was found that, compared to the declared error of a pulse oximeter of ±2 %, the errors in determining the heart rate, fractional blood saturation and respiration rate increased by 3.221 %; 2.483 % and 1.906 %, respectively. The results of theoretical and practical studies have a strong pair correlation according to Pearson, the pair correlation coefficients were 0.72, 0.83, 0.76 for the results of measurements of heart rate, fractional blood saturation level and respiratory rate, respectively, which indicates the validity of the adopted simplifi ations in the development of the mathematical model. The obtained results can be used to develop devices for non-invasive diagnostics of the pilot's physiological indicators, functioning directly during the flight.

Different Pathways of Skin Aging: Objective Instrumental Evaluation.

Background/Objectives: Hypertrophic and atrophic skin aging represent two distinct phenotypes: hypertrophic aging is marked by deep wrinkles and a leathery texture, whereas atrophic aging is characterized by overall skin thinning, increased vascularity, and a higher risk of non-melanoma skin cancers. This study aims to elucidate the characteristics and differences between hypertrophic and atrophic facial aging subtypes using two non-invasive imaging devices: VISIA® and dynamic optical coherence tomography (D-OCT). Methods: We retrospectively evaluated patients who had presented to the outpatient dermatological clinic at Policlinico Umberto I hospital in Rome, Italy for a non-invasive facial imaging check-up. We included 40 patients aged 60-75 who were imaged with VISIA® and dynamic optical coherence tomography (D-OCT). Based on the number of UV spots and amount of red found on VISIA®, subjects were grouped into four subgroups (PIGM, RED, CONTROL, PIGM + RED), and trends among them were analyzed. Results: We found a strong correlation between VISIA® red area scores and D-OCT vascular density at 300 µm depth, confirming VISIA®'s effectiveness for assessing facial vascularity. Wrinkle count was highest in areas with UV spots, particularly in the PIGM and PIGM + RED groups. Conversely, low attenuation coefficients and dermal density were observed in regions with low UV spots but high red areas. Intermediate subgroups (CONTROL and PIGM + RED) displayed varying parameters. Conclusions: Non-invasive imaging devices are effective in evaluating facial aging and distinguishing between aging subtypes. This study identified two intermediate aging types in addition to the hypertrophic and atrophic subtypes.

Effects of multicomponent exercise intervention on cardiometabolic risk factors in children and young adults with cerebral palsy: a multiple-baseline trial.

Adults with cerebral palsy (CP) have a high risk of cardiometabolic diseases. It is unknown whether this risk is elevated in young people with CP and whether exercise can reduce this risk. Therefore, we investigated the effects of the EXErcise for Cerebral Palsy (EXECP) intervention on cardiometabolic risk in children and young adults with CP and compared this risk to typically developing children and young adults (TDs). Ambulatory male and female participants with spastic CP, aged 9-24 years, and age- and sex-matched TDs without musculoskeletal disorders were recruited. Participants with CP were measured at baseline, after a three-month control period manifesting normal development, and after the three-month strength, gait, and flexibility training intervention. TDs were measured at baseline and after the control period. They did not attend the intervention. Cardiometabolic risk factors included body weight, body fat percentage, and skeletal muscle mass index assessed with bioimpedance; resting systolic and diastolic blood pressure and aortic pulse wave velocity assessed with a non-invasive oscillometric device; fasting plasma high-density and low-density lipoprotein cholesterol, triglyceride, and glucose levels. Data were analyzed with independent samples t-tests and linear mixed-effects models adjusted for sex and age. The study involved 18 participants with CP (13 males, 9-22year, mean 14.2 ± 4.4) and 17 TDs (12 males, 9-22year, mean 14.6 ± 4.3). At baseline, participants with CP had a 1.0 (95% confidence interval (CI) [-2.0, -0.0]) kg/m2 lower skeletal muscle mass index than TDs. During the control period, no statistically significant between-group differences were observed in the change of any outcome. In the CP group, body weight (β = 1.87, 95% CI [1.04, 2.70]), fat percentage (β = 1.22 [0.07, 2.37], and blood glucose (β = 0.19, 95% CI [0.01, 0.37]) increased, while diastolic blood pressure (β=-2.31, 95% CI [-4.55, -0.06]) and pulse wave velocity (β=-0.44, 95% CI [-0.73, -0.16]) decreased. In the TD group, only body weight increased (β = 0.85, 95% CI [0.01, 1.68]) statistically significantly. In the CP group, no changes were observed during the intervention. Young people with and without CP do not exhibit significant differences in most cardiometabolic risk factors. EXECP intervention may attenuate some adverse development trajectories occurring without the intervention but greater volume and intensity of aerobic exercise may be needed to reduce cardiometabolic risk. ISRCTN69044459; Registration date 21/04/2017.

Empowering Mental Health Monitoring Using a Macro-Micro Personalization Framework for Multimodal-Multitask Learning: Descriptive Study.

The field of mental health technology presently has significant gaps that need addressing, particularly in the domain of daily monitoring and personalized assessments. Current noninvasive devices such as wristbands and smartphones are capable of collecting a wide range of data, which has not yet been fully used for mental health monitoring. This study aims to introduce a novel dataset for personalized daily mental health monitoring and a new macro-micro framework. This framework is designed to use multimodal and multitask learning strategies for improved personalization and prediction of emotional states in individuals. Data were collected from 298 individuals using wristbands and smartphones, capturing physiological signals, speech data, and self-annotated emotional states. The proposed framework combines macro-level emotion transformer embeddings with micro-level personalization layers specific to each user. It also introduces a Dynamic Restrained Uncertainty Weighting method to effectively integrate various data types for a balanced representation of emotional states. Several fusion techniques, personalization strategies, and multitask learning approaches were explored. The proposed framework was evaluated using the concordance correlation coefficient, resulting in a score of 0.503. This result demonstrates the framework's efficacy in predicting emotional states. The study concludes that the proposed multimodal and multitask learning framework, which leverages transformer-based techniques and dynamic task weighting strategies, is superior for the personalized monitoring of mental health. The study indicates the potential of transforming daily mental health monitoring into a more personalized app, opening up new avenues for technology-based mental health interventions.

A Case for Co-oximetry: Methemoglobinemia secondary to a Rare Hemoglobin Variant

Abstract Introduction/Objective The presence of dyshemoglobins and some inherited hemoglobin (Hb) variants can cause over or underestimation of oxygen saturation (O2sat) when using a pulse oximeter (ox). These noninvasive medical devices rely on two wavelengths, a pulsing arterial bed, and light absorption properties of Hb to measure the difference between deoxy- and oxy-Hb. In contrast, a co-oximeter (co-ox) requires arterial blood. By using at least four wavelengths, co-ox measures the functional and fractional O2sat to detect all forms of Hb, including those that do not bind oxygen (O2), such as methemoglobin (metHb). Methemoglobinemia may be congenital or acquired, resulting from exposure to certain toxins, metabolic disorders, enzymatic deficiencies such as cytochrome b5 reductase deficiency, or hemoglobinopathies. Methods/Case Report A healthy, adolescent male undergoing a sports physical at his pediatrician’s office was hypoxic by pulse ox and sent to the emergency department (ED) for evaluation. On exam, he had cold, blue tinged fingertips and lips but was otherwise asymptomatic. His O2sat was 88-90% on room air with minimal improvement with 6L of supplemental O2. Co-ox revealed a metHb level &amp;gt; 20%. The father also mentioned that the mother had frequent ED visits for hypoxia. Capillary Hb electrophoresis showed peaks in the HbA, HbF, and HbA2 zones of 78.3%, 17.9%, and 3.6%, respectively. All CBC parameters were within the reference intervals. The large peak in the HbF zone would suggest hereditary persistence of fetal hemoglobin (HPFH); however, the clinical picture was not consistent. Further reference laboratory investigation determined that the patient was heterozygous for Hb Tübingen (HbTüb), a beta globin chain variant resulting from a point mutation at position 106. By mass spectrometry, the variant quantified as 38% of the total hemoglobin, indicating underestimation by electrophoretic techniques. Results (if a Case Study enter NA) NA Conclusion This case presents an essentially asymptomatic patient with hypoxia and elevated methemoglobin levels. Electrophoretic hemoglobinopathy and CBC workup were clinically inconsistent with HPFH and the presence of an aberrant hemoglobin migrating in the HbF must be considered in the differential diagnosis. The manifestation of HbTüb as methemoglobinemia in this context adds complexity to the diagnostic puzzle. Further laboratory exploration into the underlying mechanisms driving this unique presentation is crucial for a comprehensive understanding and tailored management approach.

X-ray/γ-ray/Ultrasound-Activated Persistent Luminescence Phosphors for Deep Tissue Bioimaging and Therapy.

Persistent luminescence phosphors (PLPs) can remain luminescent after excitation ceases and have been widely explored in bioimaging and therapy since 2007. In bioimaging, PLPs can efficiently avoid tissue autofluorescence and light scattering interference by collecting persistent luminescence signals after the end of excitation. Outstanding signal-to-background ratios, high sensitivity, and resolution have been achieved in bioimaging with PLPs. In therapy, PLPs can continuously produce therapeutic molecules such as reactive oxygen species after removing excitation sources, which realizes sustained therapeutic activity after a single dose of light stimulation. However, most PLPs are activated by ultraviolet or visible light, which makes it difficult to reactivate the PLPs in vivo, particularly in deep tissues. In recent years, excitation sources with deep tissue penetration have been explored to activate PLPs, including X-ray, γ-ray, and ultrasound. Researchers found that various inorganic and organic PLPs can be activated by X-ray, γ-ray, and ultrasound, making these PLPs valuable in the imaging and therapy of deep-seated tumors. These X-ray/γ-ray/ultrasound-activated PLPs have not been systematically introduced in previous reviews. In this review, we summarize the recently developed inorganic and organic PLPs that can be activated by X-ray, γ-ray, and ultrasound to produce persistent luminescence. The biomedical applications of these PLPs in deep-tissue bioimaging and therapy are also discussed. This review can provide instructions for the design of PLPs with deep-tissue-renewable persistent luminescence and further promote the applications of PLPs in phototheranostics, noninvasive biosensing devices, and energy harvesting.

Pilot Randomized Clinical Trial of a Passive Non-invasive Positive End-Expiratory Pressure (PEEP) Device for Delivering Positive Pressure Therapy Compared to Standard Care in Non-critically Ill Patients With COVID-19.

During the COVID-19 pandemic, there were reports of a shortage of ventilators and oxygen supply, particularly in resource-limited settings. We report the preliminary evaluation of a non-invasive positive end-expiratory pressure (PEEP) mask in hospitalized non-critically ill patients with COVID-19. We randomly assigned hospitalized adult patients with confirmed COVID-19 infection and requiring greater than 40% supplemental oxygen to either standard care oxygen delivery (control) or via Materialise passive non-invasive PEEP device mask (intervention; Belgium). The primary outcome was a change in mean respiratory rate from baseline over the first three hours after the commencement of the intervention. Secondary outcomes included dyspnea score, need for escalation of respiratory or cardiovascular support, days alive and free of ICU, and day-28 mortality. Between April 30, 2021, and October 10, 2021, we enrolled 132 (65 control, 67 intervention) patients in the study. The mean respiratory rates at baseline were 23 ± 3 and 23 ± 3 in the control and intervention groups, with no significant differences at three hours (23 ± 2.3 vs. 23 ± 2.1, p=0.14). The control group had a higher mean dyspnea score compared to the intervention group (day 5: 5.4 ± 1.6 vs. 4.7 ± 1.4, p=0.015; day 6: 4.7 ± 1.7 vs. 4.0 ± 0.7, p=0.008). A higher proportion of patients in the control group required escalation of respiratory support (38%), as compared to intervention (12%) (p=0.0004). The two groups had no significant differences across other secondary outcomes or with respect to adverse events (barotrauma, aspiration pneumonia, need for vasopressor support). The use of the novel mask compared to standard care in hospitalized non-critically ill patients with COVID-19 was not associated with reductions in the respiratory rate but was associated with a reduction in the need for escalation of respiratory support without an increase in adverse effects. Large-scale clinical trials of this device are warranted.

Comparison of Machine Learning Approaches for The Modelling of Non-Invasive Optical-Based Hemoglobin Measurement Device

This paper discusses the comparison of several machine learning approaches to build a model for our developed non-invasive optical-based hemoglobin measurement device. Optical data for hemoglobin prediction was obtained from 120 volunteering patients taken in two different time periods, i.e., experiment 1 and experiment 2. The gold standard of these data for model training was taken from laboratory hemoglobin tests conducted at IPB University’s Policlinic. The two experiments suggest that univariate feature selection and Multi-Variable Linear Regression (MVLR) are promising for model building. Simulation results for several features show that a total of 30 features were able to produce the best model with Mean Absolute Error (MAE) = 1.25 g/dL, Mean Squared Error (MSE) = 2.56 and an R-squared (R2) = 0.24. This means that the 30 coefficients obtained for the 30 most important features can be embedded in the developed non-invasive optical-based hemoglobin measurement device. However, more data is needed to produce a better model.

Tear-Based Ocular Wearable Biosensors for Human Health Monitoring.

Wearable tear-based biosensors have garnered substantial interest for real time monitoring with an emphasis on personalized health care. These biosensors utilize major tear biomarkers such as proteins, lipids, metabolites, and electrolytes for the detection and recording of stable biological signals in a non-invasive manner. The present comprehensive review delves deep into the tear composition along with potential biomarkers that can identify, monitor, and predict certain ocular diseases such as dry eye disease, conjunctivitis, eye-related infections, as well as diabetes mellitus. Recent technologies in tear-based wearable point-of-care medical devices, specifically the state-of-the-art and prospects of glucose, pH, lactate, protein, lipid, and electrolyte sensing from tear are discussed. Finally, the review addresses the existing challenges associated with the widespread application of tear-based sensors, which will pave the way for advanced scientific research and development of such non-invasive health monitoring devices.

Evaluation of tear film function by Oculus Keratograph 5M and IDRA ocular surface analyser.

The aim of this study was to evaluate the function of tear film with Oculus Keratograph 5M (Oculus K5M) and IDRA ocular surface analyser (IDRA), analyse their consistency and explore the potential of IDRA in the diagnosis of dry eye disease (DED). This cross-sectional study enrolled 36 participants (DED group, 14 eyes; non-DED group, 22 eyes). The parameters of tear film function, including the first noninvasive breakup time (fNIBUT), average NIBUT (aNIBUT), tear meniscus height (TMH), lipid layer thickness (LLT), lipid layer colour (LLC), lipid layer uniformity (LLU), morphology of meibomian glands (MGs) and MG loss, were obtained with Oculus K5M and IDRA. The consistency of parameter measurements between the two devices was evaluated. All the parameters except LLT, which can be measured only by IDRA, were not significantly different between the two instruments in DED eyes. However, IDRA reported lower values of fNIBUT, aNIBUT and TMH as well as higher MG loss scores in non-DED eyes than Oculus K5M did (p < 0.001, < 0.001, = 0.002, and = 0.002, respectively). Further regression analysis revealed that aNIBUT and LLT measured by IDRA were the optimal parameters for diagnosing DED (OR = 0.567 and 0.845, p = 0.057 and 0.043, respectively), and their combination had the strongest diagnostic potential (AUC = 0.841, sensitivity = 85.7%, and specificity = 77.3%). As a user-friendly noninvasive device, the tear film function parameters measured by IDRA were highly consistent with those measured by Oculus K5M in DED patients. The combination of aNIBUT and LLT measured by IDRA had the best diagnostic accuracy for DED.

Using noninvasive imaging to assess manual lymphatic drainage on lymphatic/venous responses in a spaceflight analog

This retrospective case series (clinicaltrials.gov NCT06405282) used noninvasive imaging devices (NIID) to assess the effect of manual lymphatic drainage (MLD) on dermal/venous fluid distribution, perfusion, and temperature alterations of the head, neck, upper torso, and legs while in the 6-degree head-down tilt validated spaceflight analog. A lymphatic fluid scanner measured tissue dielectric constant levels. Near-infrared spectroscopy assessed perfusion, by measuring tissue oxygenation saturation. Long-wave infrared thermography measured tissue temperature gradients. Fifteen healthy, university students participated. NIID assessments were taken 1 minute after assuming the HDT position and then every 30 minutes, with MLD administered from 180 to 195 minutes. Subjects returned to the sitting position and were assessed at post-225 min NIID demonstrated significant changes from baseline (p < 0.01), although these changes at areas of interest varied. MLD had a reverse effect on all variables. NIID assessment supported the potential use of MLD to mitigate fluid shifts during a spaceflight analog.

Maternal vascular indices and hemodynamic parameters at 36 weeks' gestation in gestational and pre-existing diabetes mellitus.

To compare maternal vascular indices and hemodynamic parameters at 35-37 weeks' gestation in pregnancies complicated by gestational diabetes mellitus (GDM), those with pre-existing diabetes mellitus (DM) and those without GDM or pre-existing DM. This was a prospective observational study in women with a singleton pregnancy attending for a routine hospital visit at 35 + 0 to 36 + 6 weeks' gestation. The visit included recording of maternal demographic characteristics and medical history, and measurement of vascular indices and hemodynamic parameters using a non-invasive operator-independent device. These included carotid-to-femoral pulse-wave velocity, augmentation index, cardiac output, stroke volume, central systolic and diastolic blood pressure, total peripheral resistance and heart rate. The values in the GDM and pre-existing DM groups were compared to those in the unaffected group. We examined 6746 women, of whom 396 were excluded because they had chronic hypertension or developed pre-eclampsia or gestational hypertension. The study population of 6350 pregnancies contained 99 (1.6%) with pre-existing Type-I or Type-II DM and 617 (9.7%) that developed GDM, including 261 (42.3%) that were treated with diet alone, 239 (38.7%) treated with metformin alone and 117 (19.0%) treated with insulin with or without metformin. Among women with GDM and those with pre-existing DM, compared to those without GDM or pre-existing DM, there was a higher median cardiac output and heart rate, central systolic and diastolic blood pressure and pulse-wave velocity, but there was no significant difference in stroke volume and total peripheral resistance. There were no significant differences within the GDM group according to treatment type, except for higher heart rate in women treated with metformin alone compared to the group treated with diet alone. Women with GDM and those with pre-existing DM have evidence of early vascular disease in the third trimester, and this may contribute to their increased long-term cardiovascular risk. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.

Electromagnetic stimulation to reduce the hypertonia of the pelvic floor muscles and improve chronic pelvic pain in women.

The increased hypertonicity or activity of pelvic floor muscles can lead to chronic pelvic pain (CPP). It represents an aspecific and persistent pain with no apparent clinical reason, affecting an estimated 6% to 16% of women worldwide. This study aimed to evaluate with validated questionnaires the efficacy and the safeness of a new device that uses Top flat Magnetic Stimulation for the management of muscular hypertonia in women with CCP. All patients underwent 8 treatments with a non-invasive electromagnetic therapeutic device. The device produces a TOP Flat Magnetic Stimulation with a uniform profile so, the muscle work aims to reduce pain while also inhibiting muscle activity. The PISQ-12 questionnaire was used for the evaluation of improvements. Side effects were monitored. The PISQ-12 total mean score decreases from 29,2 (±3.3) to 17 (±2). Regarding the behavioural-emotive items (1-4), a decrease from 12 (±2) to 7 (±0.9) was visible. Physical items (5-9) decrease from 10,6 (±1.8) to 6 (±1.4) and the Partner Related items (10-12) from 6,6 (±1.6) to 3,9 (±0.4). Conclusions: The device we used in this research demonstrated to be a valid solution for the treatment of chronic pelvic pain in female patients.

Early Diagnosis of Bronchopulmonary Dysplasia with E-Nose: A Pilot Study in Preterm Infants

Bronchopulmonary dysplasia (BPD) is the most common respiratory disease in preterm and is still associated with increased mortality and morbidity. The great interest lies in identifying early biomarkers that can predict the development of BPD. This pilot study explores the potential of e-nose for the early identification of BPD risk in premature infants by analyzing volatile organic compounds (VOCs) in the exhaled breath condensate (EBC). Fourteen mechanically ventilated very preterm infants were included in this study. The clinical parameters and EBC were collected within the first 24 h of life. The discriminative ability of breath prints between preterms who did and did not develop BPD was investigated using pattern recognition, a machine learning algorithm, and standard statistical methods. We found that e-nose probes can significantly predict the outcome of “no-BPD” vs. “BPD”. Specifically, a subset of probes (S18, S24, S14, and S6) were found to be significantly predictive, with an AUC of 0.87, 0.89, 0.82, 0.8, and p = 0.019, 0.009, 0.043, 0.047, respectively. The e-nose is an easy-to-use, handheld, non-invasive electronic device that quickly samples breath. Our preliminary study has shown that it has the potential for early prediction of BPD in preterms.

Are previously validated blood pressure self-measurement devices accepted under the Universal Standard? A systematic review.

This study aimed to analyze whether oscillometric blood pressure devices validated for the general population may be considered approved under Universal Standard criteria. A systematic review was conducted, with searches in nine databases, up to September 2023, including 32 validation studies of noninvasive arm cuff devices for self-measurement. The British Hypertension Society protocol was most common (68%), followed by the Association for the Advancement of Medical Instrumentation (40%). Most devices met Universal Standard criterion 1, but only 17 (53%) met criterion 2. Few studies contained details about the choice of cuffs, the number of participants by arm circumference, or the differences between methods by cuff subgroup. Due to the considerable differences between validation protocols, 53% of the devices analyzed were approved under the Universal Standard. The study contributes to expanding the validated pool of self-measurement devices under the Universal Standard.

Raw Photoplethysmography as an Enhancement for Research-Grade Wearable Activity Monitors.

Wearable monitors continue to play a critical role in scientific assessments of physical activity. Recently, research-grade monitors have begun providing raw data from photoplethysmography (PPG) alongside standard raw data from inertial sensors (accelerometers and gyroscopes). Raw PPG enables granular and transparent estimation of cardiovascular parameters such as heart rate, thus presenting a valuable alternative to standard PPG methodologies (most of which rely on consumer-grade monitors that provide only coarse output from proprietary algorithms). The implications for physical activity assessment are tremendous, since it is now feasible to monitor granular and concurrent trends in both movement and cardiovascular physiology using a single noninvasive device. However, new users must also be aware of challenges and limitations that accompany the use of raw PPG data. This viewpoint paper therefore orients new users to the opportunities and challenges of raw PPG data by presenting its mechanics, pitfalls, and availability, as well as its parallels and synergies with inertial sensors. This includes discussion of specific applications to the prediction of energy expenditure, activity type, and 24-hour movement behaviors, with an emphasis on areas in which raw PPG data may help resolve known issues with inertial sensing (eg, measurement during cycling activities). We also discuss how the impact of raw PPG data can be maximized through the use of open-source tools when developing and disseminating new methods, similar to current standards for raw accelerometer and gyroscope data. Collectively, our comments show the strong potential of raw PPG data to enhance the use of research-grade wearable activity monitors in science over the coming years.

Sensitivity Approach for Blood Glucose Impedance Data Using the Geselowitz Theorem

The article presents a preclinical study focused on developing a non-invasive blood glucose monitoring device. Current glucose monitoring methods, such as capillary or venous tests, are inconvenient for frequent use, making continuous monitoring challenging. This study explores the BGP (Bruna Gabriela Pedro) model, which links electrical impedance to blood glucose levels, as a potential alternative. Using the Geselowitz Theorem and impedance spectroscopy in a 4-electrode configuration, the study investigates the relationship between blood conductivity and glucose concentration. Impedance spectra were recorded for five human blood samples with glucose concentrations between 106 and 188 mg/dL. These samples were housed in an insulating container with four stainless steel electrodes. Conductivity was calculated using the Geselowitz Theorem at 1.0, 3.9, and 24.9 kHz. A finite element model built in COMSOL was employed to assess electrode sensitivity, which had a maximum regression error of 3.75 %. The results demonstrated a sigmoid relationship between blood glucose concentration and conductivity, with impedance decreasing non-linearly as glucose levels increased. Sensitivity diminished for glucose concentrations exceeding 188 mg/dL. An increase of 82 mg/dL in glucose concentration led to conductivity changes of 1.14, 2.82, and 5.14 S/m at frequencies of 1.0, 3.9, and 24.9 kHz, respectively. The findings suggest that the BGP analytical model could be refined through the inclusion of additional data on glucose's impact on electrical impedance. These improvements could support the development of non-invasive glucose meters. The research holds significant clinical potential for the creation of a simple, cost-effective glucose monitoring device. Continuous glucose monitoring could enhance diagnostic accuracy and support better therapeutic decision-making, particularly in emergency care. The affordability and accessibility of such a device may benefit a broad patient base.