Validity and reliability study of a novel surface electromyography sensor using a well-consolidated electromyography system in individuals with cervical spinal cord injury.

STUDY DESIGN: Non-interventional, cross-sectional pilot study. OBJECTIVES: To establish the validity and reliability of the BioStamp nPoint biosensor (Medidata Solutions, New York, NY, USA [formerly MC10, Inc.]) for measuring electromyography in individuals with cervical spinal cord injury (SCI) by comparing the surface electromyography (sEMG) metrics with the Trigno wireless electromyography system (Delsys, Natick, MA, USA). SETTING: Participants were recruited from the Shirley Ryan AbilityLab registry. METHODS: Individuals aged 18-70 years with cervical SCI were evaluated with the two biosensors to capture activity on upper-extremity muscles during two study sessions conducted over 2 days (day 1-consent alone; day 2-two data collections in same session). Time and frequency metrics were captured, and signal-to-noise ratio was determined for each muscle group. Test-retest reliability was determined using Pearson's correlation. Validation of the BioStamp nPoint system was based on Bland-Altmann analysis. RESULTS: Among the 11 participants, 30.8% had subacute cervical injury at C5-C6; 53.8% were injured within 1 year of the study. Results from the test-retest reliability assessment revealed that most Pearson's correlations between the two sensory measurements were strong (≥0.50). The Bland-Altman analysis found values of the signal-to-noise ratio, frequency, and peak amplitude were within the level of agreement. Signal-to-noise ratios ranged from 7.06 to 22.1. CONCLUSIONS: In most instances, the performance of the BioStamp nPoint sensors was moderately to strongly correlated with that of the Trigno sensors in all muscle groups tested. The BioStamp nPoint system is a valid and reliable approach to assess sEMG measures in individuals with cervical SCI. SPONSORSHIP: The present study was supported by AbbVie Inc.

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments.

BACKGROUND: Increasingly, drug and device clinical trials are tracking activity levels and other quality of life indices as endpoints for therapeutic efficacy. Trials have traditionally required intermittent subject visits to the clinic that are artificial, activity-intensive, and infrequent, making trend and event detection between visits difficult. Thus, there is an unmet need for wearable sensors that produce clinical quality and medical grade physiological data from subjects in the home. The current study was designed to validate the BioStamp nPoint® system (MC10 Inc., Lexington, MA, USA), a new technology designed to meet this need. OBJECTIVE: To evaluate the accuracy, performance, and ease of use of an end-to-end system called the BioStamp nPoint. The system consists of an investigator portal for design of trials and data review, conformal, low-profile, wearable biosensors that adhere to the skin, a companion technology for wireless data transfer to a proprietary cloud, and algorithms for analyzing physiological, biometric, and contextual data for clinical research. METHODS: A prospective, nonrandomized clinical trial was conducted on 30 healthy adult volunteers over the course of two continuous days and nights. Supervised and unsupervised study activities enabled performance validation in clinical and remote (simulated "at home") environments. System outputs for heart rate (HR), heart rate variability (HRV) (including root mean square of successive differences [RMSSD] and low frequency/high frequency ratio), activity classification during prescribed activities (lying, sitting, standing, walking, stationary biking, and sleep), step count during walking, posture characterization, and sleep metrics including onset/wake times, sleep duration, and respiration rate (RR) during sleep were evaluated. Outputs were compared to FDA-cleared comparator devices for HR, HRV, and RR and to ground truth investigator observations for activity and posture classifications, step count, and sleep events. RESULTS: Thirty participants (77% male, 23% female; mean age 35.9 ± 10.1 years; mean BMI 28.1 ± 3.6) were enrolled in the study. The BioStamp nPoint system accurately measured HR and HRV (correlations: HR = 0.957, HRV RMSSD = 0.965, HRV ratio = 0.861) when compared to ActiheartTM. The system accurately monitored RR (mean absolute error [MAE] = 1.3 breaths/min) during sleep when compared to a Capnostream35TM end-tidal CO2 monitor. When compared with investigator observations, the system correctly classified activities and posture (agreement = 98.7 and 92.9%, respectively), step count (MAE = 14.7, < 3% of actual steps during a 6-min walk), and sleep events (MAE: sleep onset = 6.8 min, wake = 11.5 min, sleep duration = 13.7 min) with high accuracy. Participants indicated "good" to "excellent" usability (average System Usability Scale score of 81.3) and preferred the BioStamp nPoint system over both the Actiheart (86%) and Capnostream (97%) devices. CONCLUSIONS: The present study validated the BioStamp nPoint system's performance and ease of use compared to FDA-cleared comparator devices in both the clinic and remote (home) environments.

Clinical feasibility of a wearable, conformable sensor patch to monitor motor symptoms in Parkinson's disease.

INTRODUCTION: Clinical assessment of motor symptoms in Parkinson's disease (PD) is subjective and may not reflect patient real-world experience. This two-part pilot study evaluated the accuracy of the NIMBLE wearable biosensor patch (containing an accelerometer and electromyography sensor) to record body movements in clinic and home environments versus clinical measurement of motor symptoms. METHODS: Patients (Hoehn & Yahr 2-3) had motor symptom fluctuations and were on a stable levodopa dose. Part 1 investigated different sensor body locations (six patients). In Part 2, 21 patients wore four sensors (chest, and most affected side of shin, forearm and back-of-hand) during a 2-day clinic- and 1-day home-based evaluation. Patients underwent Unified Parkinson's Disease Rating Scale assessments on days 1-2, and performed pre-defined motor activities at home on day 3. An algorithm estimated motor-symptom severity (predicted scores) using patch data (in-clinic); this was compared with in-clinic motor symptom assessments (observed scores). RESULTS: The overall correlation coefficient between in-clinic observed and sensor algorithm-predicted scores was 0.471 (p = 0.031). Predicted and observed scores were identical 45% of the time, with a predicted score within a ±1 range 91% of the time. Exact accuracy for each activity varied, ranging from 32% (pronation/supination) to 67% (rest-tremor-amplitude). Patients rated the patch easy-to-use and as providing valuable data for managing PD symptoms. Overall patch-adhesion success was 97.2%. The patch was safe and generally well tolerated. CONCLUSIONS: This study showed a correlation between sensor algorithm-predicted and clinician-observed motor-symptom scores. Algorithm refinement using patient populations with greater symptom-severity range may potentially improve the correlation.

A novel adhesive biosensor system for detecting respiration, cardiac, and limb movement signals during sleep: validation with polysomnography.

BACKGROUND: Although in-lab polysomnography (PSG) remains the gold standard for objective sleep monitoring, the use of at-home sensor systems has gained popularity in recent years. Two categories of monitoring, autonomic and limb movement physiology, are increasingly recognized as critical for sleep disorder phenotyping, yet at-home options remain limited outside of research protocols. The purpose of this study was to validate the BiostampRC® sensor system for respiration, electrocardiography (ECG), and leg electromyography (EMG) against gold standard PSG recordings. METHODS: We report analysis of cardiac and respiratory data from 15 patients and anterior tibialis (AT) data from 19 patients undergoing clinical PSG for any indication who simultaneously wore BiostampRC® sensors on the chest and the bilateral AT muscles. BiostampRC® is a flexible, adhesive, wireless sensor capable of capturing accelerometry, ECG, and EMG. We compared BiostampRC® data and feature extractions with those obtained from PSG. RESULTS: The heart rate extracted from BiostampRC® ECG showed strong agreement with the PSG (cohort root mean square error of 5 beats per minute). We found the thoracic BiostampRC® respiratory waveform, derived from its accelerometer, accurately calculated the respiratory rate (mean average error of 0.26 and root mean square error of 1.84 breaths per minute). The AT EMG signal supported periodic limb movement detection, with area under the curve of the receiver operating characteristic curve equaling 0.88. Upon completion, 88% of subjects indicated willingness to wear BiostampRC® at home on an exit survey. CONCLUSION: The results demonstrate that BiostampRC® is a tolerable and accurate method for capturing respiration, ECG, and AT EMG time series signals during overnight sleep when compared with simultaneous PSG recordings. The signal quality sufficiently supports analytics of clinical relevance. Larger longitudinal in-home studies are required to support the role of BiostampRC® in clinical management of sleep disorders involving the autonomic nervous system and limb movements.

Highly flexible, wearable, and disposable cardiac biosensors for remote and ambulatory monitoring.

Contemporary cardiac and heart rate monitoring devices capture physiological signals using optical and electrode-based sensors. However, these devices generally lack the form factor and mechanical flexibility necessary for use in ambulatory and home environments. Here, we report an ultrathin (~1 mm average thickness) and highly flexible wearable cardiac sensor (WiSP) designed to be minimal in cost (disposable), light weight (1.2 g), water resistant, and capable of wireless energy harvesting. Theoretical analyses of system-level bending mechanics show the advantages of WiSP's flexible electronics, soft encapsulation layers and bioadhesives, enabling intimate skin coupling. A clinical feasibility study conducted in atrial fibrillation patients demonstrates that the WiSP device effectively measures cardiac signals matching the Holter monitor, and is more comfortable. WiSP's physical attributes and performance results demonstrate its utility for monitoring cardiac signals during daily activity, exertion and sleep, with implications for home-based care.

Soft, stretchable, epidermal sensor with integrated electronics and photochemistry for measuring personal UV exposures.

Excessive ultraviolet (UV) radiation induces acute and chronic effects on the skin, eye and immune system. Personalized monitoring of UV radiation is thus paramount to measure the extent of personal sun exposure, which could vary with environment, lifestyle, and sunscreen use. Here, we demonstrate an ultralow modulus, stretchable, skin-mounted UV patch that measures personal UV doses. The patch contains functional layers of ultrathin stretchable electronics and a photosensitive patterned dye that reacts to UV radiation. Color changes in the photosensitive dyes correspond to UV radiation intensity and are analyzed with a smartphone camera. A software application has feature recognition, lighting condition correction, and quantification algorithms that detect and quantify changes in color. These color changes are then correlated with corresponding shifts in UV dose, and compared to existing UV dose risk levels. The soft mechanics of the UV patch allow for multi-day wear in the presence of sunscreen and water. Two evaluation studies serve to demonstrate the utility of the UV patch during daily activities with and without sunscreen application.

Techniques and evaluation from a cross-platform imaging comparison of quantitative ultrasound parameters in an in vivo rodent fibroadenoma model.

This contribution demonstrates that quantitative ultrasound (QUS) capabilities are platform independent, using an in vivo model. Frequency-dependent attenuation estimates, backscatter coefficient, and effective scatterer diameter estimates are shown to be comparable across four different ultrasound imaging systems with varied processing techniques. The backscatter coefficient (BSC) is a fundamental material property from which several QUS parameters are estimated; therefore, consistent BSC estimates among different systems must be demonstrated. This study is an intercomparison of BSC estimates acquired by three research groups (UIUC, UW, ISU) from four in vivo spontaneous rat mammary fibroadenomas using three clinical array systems and a single-element laboratory scanner system. Because of their highly variable backscatter properties, fibroadenomas provided an extreme test case for BSC analysis, and the comparison is across systems for each tumor, not across the highly heterogeneous tumors. RF echo data spanning the 1 to 12 MHz frequency range were acquired in three dimensions from all animals using each system. Each research group processed their RF data independently, and the resulting attenuation, BSC, and effective scatterer diameter (ESD) estimates were compared. The attenuation estimates across all systems showed the same trends and consistently fit the power-law dependence on frequency. BSCs varied among the multiple slices of data acquired by each transducer, with variations between transducers being of a similar magnitude as those from slice to slice. Variation between BSC estimates was assessed via functional signal-to-noise ratios derived from backscatter data. These functional signal-to-noise ratios indicated that BSC versus frequency variations between systems ranged from negligible compared with the noise level to roughly twice the noise level. The corresponding functional analysis of variance (fANOVA) indicated statistically significant differences between BSC curves from different systems. However, root mean squared difference errors of the BSC values (in decibels) between different transducers and imaging platforms were less than half of the BSC magnitudes in most cases. Statistical comparison of the effective scatterer diameter (ESD) estimates resulted in no significant differences in estimates from three of the four transducers used for those estimates, demonstrating agreement among estimates based on the BSC. This technical advance demonstrates that these in vivo measurements can be made in a system-independent manner; the necessary step toward clinical implementation of the technology.