A novel pilot study to evaluate the efficacy and safety of a wireless patch system in patients with chronic nausea and vomiting.

BACKGROUND: Gastric sensorimotor disorders (functional dyspepsia [FD] and gastroparesis [GP]) are prevalent and burdensome. Prolonged ambulatory recording using a wireless patch may provide novel information in these patients. METHODS: Consecutive adult patients (age ≥ 18 years) referred for gastric emptying scintigraphy (GES) were eligible for study inclusion. Patients were excluded if they had prior foregut surgery; were taking opioids or other medications known to affect gastric emptying; had a HgbA1C > 10; or were recently hospitalized. Three wireless motility patches were applied to the skin prior to GES. Patients wore the patches for 6 days while recording meals, symptoms, and bowel movements using an iPhone app. KEY RESULTS: Twenty-three consecutive adults (87% women; mean age = 43.9 years; mean BMI = 26.7 kg/m2) were enrolled. A gastric histogram revealed three levels of gastric myoelectric activity: weak, moderate, and strong. Patients with delayed gastric emptying at 4 h had weak gastric myoelectrical activity. Patients with nausea and vomiting had strong intestinal activity. Those with FD had weak gastric and intestinal myoelectric activity, and a weak meal response in the stomach, intestine, and colon compared to those with nausea alone or vomiting alone. CONCLUSIONS AND INFERENCES: Patients with FD, and those with delayed gastric emptying, had unique gastrointestinal myoelectrical activity patterns. Reduced postprandial pan-intestinal myoelectric activity may explain the symptoms of FD in some patients. Recording gastrointestinal activity over a prolonged period in the outpatient setting has the potential to identify unique pathophysiologic patterns and meal-related activity that distinguishes patients with distinct gastric sensorimotor disease states.

Gastrointestinal Myoelectric Measurements via Simultaneous External and Internal Electrodes in Pigs.

INTRODUCTION: Currently, there is no accurate noninvasive measurement system to diagnose gastrointestinal (GI) motility disorders. Wireless skin patches have been introduced to provide an accurate noninvasive measurement of GI myoelectric activity which is essential for developing neuro-stimulation devices to treat GI motility disorders. The aim of this study is to compare the external and internal electrical signal measurements in ambulatory pigs. METHODS: Yucatan pigs underwent placement of internal electrodes on the stomach, small intestine, and colon. Wires were brought through the abdominal wall. Signals were collected by a wireless receptor. Four external patches were placed on the abdominal skin to record the signals simultaneously. Pigs were kept for 6 d while the sensors were continuously recording the data from both systems. RESULTS: Internal sensors detected rich signals from each organ. The stomach had a dominant frequency that ranged from 4 to 4.5 cpm, with occasional higher frequencies at 2, 3 and 4 times that. Small intestine signals had their primary energy in the 12-15 cpm range. Colon signals primarily displayed a dominant broad peak in the 4-6 cpm region. External skin patches detected a substantial fraction of the activities measured by the internal electrodes. A clear congruence in the frequency spectrum was observed between the internal and external readings. CONCLUSIONS: Internally measured myoelectrical signals confirmed different patterns of rhythmic activity of the stomach, small intestine, and colon. Skin patches provided GI myoelectric measurement with a range of frequencies that could be useful in the diagnosis and treatment of motility disorders.

Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations.

BACKGROUND AND AIMS: Limited means exist to assess gastrointestinal activity in a noninvasive, objective way that is highly predictive of underlying motility disorders. The aim of this paper is to demonstrate the feasibility of recording myoelectric gastrointestinal activity by cutaneous patches and to correlate myoelectric signals with gastrointestinal function in various clinical settings. METHODS: A novel wireless patch system (WPS) (G-Tech Medical) that acquires gastrointestinal myoelectrical signals was placed on the patients' anterior abdomens. Data were transmitted wirelessly to a mobile device with a user interface and forwarded to a cloud server where processing algorithms identified episodes of motor activity, quantified their parameters, and nominally assigned them to specific gastrointestinal organs based on their frequencies. RESULTS: The inherent reproducibility of the WPS measurement technique itself and from the underlying gut activity, coupled with source validation and sensitivity to changes in gut activity in several physiologic and pathologic states, demonstrates its feasibility, safety, and performance in clinical settings. CONCLUSIONS: The novel WPS technology, measuring myoelectric intestinal activity noninvasively and continuously over multiple days, is feasible in a wide range of clinical settings, highlighting its promise in the diagnosis and management of motility disorders. Further research is required for more extensive validation and to determine how best to employ this information to optimize patient care.

Cutaneous Patches to Monitor Myoelectric Activity of the Gastrointestinal Tract in Postoperative Pediatric Patients.

PURPOSE: Limited means exist to assess gastrointestinal activity in pediatric patients postoperatively. Recently, myoelectric gastrointestinal activity recorded by cutaneous patches has been shown in adult patients to be predictive of clinical return of gastrointestinal function postoperatively. The aim of this case series is to demonstrate the feasibility of this system in pediatric patients and to correlate myoelectric signals with return of bowel function clinically. METHODS: Pediatric patients undergoing abdominal surgery were recruited to have wireless patches placed on the abdomen within two hours postoperatively. Myoelectric data were transmitted wirelessly to a mobile device with a user-interface and forwarded to a cloud server where processing algorithms identified episodes of motor activity, quantified their parameters and nominally assigned them to specific gastrointestinal organs based on their frequencies. RESULTS: Three patients (ages 5 months, 4 year, 16 year) were recruited for this study. Multiple patches were placed on the older subjects, while the youngest had a single patch due to space limitations. Rhythmic signals of the stomach, small intestine, and colon could be identified in all three subjects. Patients showed gradual increase in myoelectric intestinal and colonic activity leading up to the first recorded bowel movement. CONCLUSION: Measuring myoelectric intestinal activity continuously using a wireless patch system is feasible in a wide age range of pediatric patients. The increase in activity over time correlated well with the patients' return of bowel function. More studies are planned to determine if this technology can predict return of bowel function or differentiate between physiologic ileus and pathologic conditions.

Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus.

BACKGROUND: Passage of flatus after abdominal surgery signals resolution of physiological postoperative ileus (POI) and often, particularly after complex open surgeries, serves as the trigger to initiate oral feeding. To date, there is no objective tool that can predict time to flatus allowing for timely feeding and optimizing recovery. In an open, prospective study, we examine the use of a noninvasive wireless patch system that measures electrical activity from gastrointestinal smooth muscles in predicting time to first flatus. METHODS: Eighteen patients who underwent open abdominal surgery at El Camino Hospital, Mountain View, CA, were consented and studied. Immediately following surgery, wireless patches were placed on the patients' anterior abdomen. Colonic frequency peaks in the spectra were identified in select time intervals and the area under the curve of each peak times its duration was summed to calculate cumulative myoelectrical activity. RESULTS: Patients with early flatus had stronger early colonic activity than patients with late flatus. At 36 h post-surgery, a linear fit of time to flatus vs cumulative colonic myoelectrical activity predicted first flatus as much as 5 days (± 22 h) before occurrence. CONCLUSIONS: In this open, prospective pilot study, noninvasive measurement of colon activity after open abdominal surgery was feasible and predictive of time to first flatus. Interventions such as feeding can potentially be optimized based on this prediction, potentially improving outcomes, decreasing length of stay, and lowering costs.

Monitoring gastric myoelectric activity after pancreaticoduodenectomy for diet "readiness".

Postoperative delayed gastric emptying (DGE) is a frustrating complication of pancreaticoduodenectomy (PD). We studied whether monitoring of postoperative gastric motor activity using a novel wireless patch system can identify patients at risk for DGE. Patients ( n = 81) were prospectively studied since 2016; 75 patients total were analyzed for this study. After PD, battery-operated wireless patches (G-Tech Medical) that acquire gastrointestinal myoelectrical signals are placed on the abdomen and transmit data by Bluetooth. Patients were divided into early and late groups by diet tolerance of 7 days [enhanced recovery after surgery (ERAS) goal]. Subgroup analysis was done of patients included after ERAS initiation. The early and late groups had 50 and 25 patients, respectively, with a length of stay (LOS) of 7 and 11 days ( P < 0.05). Nasogastric insertion was required in 44% of the late group. Tolerance of food was noted by 6 versus 9 days in the early versus late group ( P < 0.05) with higher cumulative gastric myoelectrical activity. Diminished gastric myoelectrical activity accurately identified delayed tolerance to regular diet in a logistical regression analysis [area under the curve (AUC): 0.81; 95% confidence interval (CI), 0.74-0.92]. The gastric myoelectrical activity also identified a delayed LOS status with an AUC of 0.75 (95% CI, 0.67-0.88). This stomach signal continued to be predictive in 90% of the ERAS cohort, despite earlier oral intake. Measurement of gastric activity after PD can distinguish patients with shorter or longer times to diet. This noninvasive technology provides data to identify patients at risk for DGE and may guide the timing of oral intake by gastric "readiness." NEW & NOTEWORTHY Limited clinical indicators exist after pancreaticoduodenectomy to allow prediction of delayed gastric emptying (DGE). This study introduces a novel, noninvasive, wireless patch system capable of accurately monitoring gastric myoelectric activity after surgery. This system can differentiate patients with longer or shorter times to a regular diet as well as provide objective data to identify patients at risk for DGE. This technology has the potential to individualize feeding regimens based on gastric activity patterns to improve outcomes.

Primary migration of a mini-implant under a functional orthodontic loading.

OBJECTIVES: The objective of this study was to examine whether cortical bone thickness and bone mineral density (BMD) can explain the primary migration of a mini-implant under a functional orthodontic tangential loading at the early stage following implantation. MATERIALS AND METHODS: Mini-implants were installed in human mandibular sections. A constant tangential load (2 N) was applied to the mini-implant under hydration. Creep, which is a time-dependent viscoelastic displacement in the bone surrounding the mini-implant, was assessed as the change in displacement during 2 h of loading. The total migration was measured as a maximum displacement that combined an initial elastic displacement and creep. After removal of the mini-implant, all specimens were scanned together by cone beam computed tomography. Cortical bone thickness and BMD were measured for the bone voxels surrounding the implant site. RESULTS: BMD had significant correlations with the displacement parameters (p < 0.019), but the cortical bone thickness did not (p > 0.272). Permanent bone deformation adjacent to the implant was observed to be resulting from substantial creep development under the orthodontic functional loading level. CONCLUSIONS: BMD controls the primary migration of the mini-implant system in mandibular bone. Viscoelastic creep can develop at a small constant functional loading level, leading to migration of the mini-implant. CLINICAL RELEVANCE: The current results indicated that mini-implant migration can develop under the small level of functional orthodontic load used in clinic. If the active bone remodeling around the mini-implant accelerates the migration, the risk of causing damage in vital organs next to the mini-implant increases.

Trunk muscle reflex amplitudes increased in patients with subacute, recurrent LBP treated with a 10-week stabilization exercise program.

Altered trunk muscle reflexes have been observed in patients with low back pain (LBP). Altered reflexes may contribute to impaired postural control, and possibly recurrence of LBP. Specific stabilization exercise (SSE) programs have been shown to decrease the risk of LBP recurrence in a select group of patients with acute, first episode LBP. It is not known if trunk muscle reflex responses improve with resolution of subacute, recurrent LBP when treated with a SSE program. A perturbation test was used to compare trunk muscle reflexes in patients with subacute, recurrent LBP, before and after 10 weeks of a SSE program and a group of matched control subjects (CNTL). The LBP group pre therapy had delayed trunk muscle reflexes compared with the CNTL group. Post therapy reflex latencies remained delayed, but amplitudes increased. Increased reflex amplitudes could limit excessive movement of the spine when perturbed; potentially helping prevent recurrence.

Effect of estrogen deficiency on regional variation of a viscoelastic tissue property of bone.

Estrogen deficiency changes the regional distribution of tissue mineral density leading to alteration of the mechanical properties of bone at the tissue level. Direct measurement of the regional variation of elastic modulus and viscosity, which is the capacity to resist time-dependent viscoelastic deformation, will aid in our understanding of how estrogen deficiency alters bone quality. It was observed that, compared to bone from other anatomical sites, the jaw bone is less sensitive to estrogen deficiency. Thus, the objective of this study was to examine the effect of estrogen deficiency on (1) the regional variations of tissue modulus and viscosity of bone using nanoindentation, and (2) the modulus-viscosity relationships in jaw and vertebral bones for comparison between different anatomical sites. Mandibular and vertebral bone specimens of sham surgery and ovariectomized (OVX) rat groups were subject to nanoindentation in hydration. Indentation modulus and viscosity were measured at relatively new (less mineralized) tissue regions and at the corresponding pre-existing old (more mineralized) tissue regions of mandibular and vertebral bones. In the mandibular bones, significant regional variations of indentation modulus and viscosity were observed (p<0.039) and OVX increased the indentation viscosity. While significant positive correlations were found between indentation modulus and viscosity (p<0.001), the correlation slopes for the mandibular and vertebral bones were significant different (p<0.001). The current results indicated that changes in viscoelastic property and its regional variation should be examined to obtain a better understanding of estrogen deficiency-dependent alteration of bone quality.

Increased variability of bone tissue mineral density resulting from estrogen deficiency influences creep behavior in a rat vertebral body.

Progressive vertebral deformation increases the fracture risk of a vertebral body in the postmenopausal patient. Many studies have observed that bone can demonstrate creep behavior, defined as continued time-dependent deformation even when mechanical loading is held constant. Creep is a characteristic of viscoelastic behavior, which is common in biological materials. We hypothesized that estrogen deficiency-dependent alteration of the mineral distribution of bone at the tissue level could influence the progressive postmenopausal vertebral deformity that is observed as the creep response at the organ level. The objective of this study was thus to examine whether the creep behavior of vertebral bone is changed by estrogen deficiency, and to determine which bone property parameters are responsible for the creep response of vertebral bone at physiological loading levels using an ovariectomized (OVX) rat model. Correlations of creep parameters with bone mineral density (BMD), tissue mineral density (TMD) and architectural parameters of both OVX and sham surgery vertebral bone were tested. As the vertebral creep was not fully recovered during the post-creep unloading period, there was substantial residual displacement for both the sham and OVX groups. A strong positive correlation between loading creep and residual displacement was found (r=0.868, p<0.001). Of the various parameters studied, TMD variability was the parameter that best predicted the creep behavior of the OVX group (p<0.038). The current results indicated that creep caused progressive, permanent reduction in vertebral height for both the sham and OVX groups. In addition, estrogen deficiency-induced active bone remodeling increased variability of trabecular TMD in the OVX group. Taken together, these results suggest that increased variability of trabecular TMD resulting from high bone turnover influences creep behavior of the OVX vertebrae.

Viscoelastic properties of elastomeric chains: an investigation of pigment and manufacturing effects.

INTRODUCTION: Orthodontic elastomeric chains are commercially available in various colors from many manufacturers. In this study, we investigated the viscoelastic properties of elastomeric chains using dynamic mechanical analysis to perform color and brand comparisons. METHODS: Ten colors of Sunburst chains (GAC International, Bohemia, NY) were selected for the color study. Three colors of Sunburst, Bobbin Alastik (3M Unitek, Monrovia, Calif), and Energy (Rocky Mountain Orthodontics, Denver, Colo) chains were selected for the brand study. Nine specimens of each type were measured and tested. Dynamic mechanical analysis was performed at room temperature at 8 frequencies ranging from 0.125 to 16.0 Hz. Three variables (storage stiffness, loss stiffness, and tan δ) were analyzed by using repeated-measures analysis of variance (ANOVA) and pairwise t tests, comparing all frequencies for each specimen type and all specimen types for each frequency (with Bonferroni corrections). Significance was set at α = 0.05. RESULTS: Significant differences were found among all specimen dimensions, all frequencies, and all 3 dynamic mechanical analysis variables in both the color and brand studies. Comparisons focused on tan δ, which does not depend on specimen dimensions as do storage stiffness and loss stiffness. CONCLUSIONS: Statistically significant differences in tan δ values among colors were relatively small, so the clinical significance is questionable and requires further investigation. Differences in tan δ values among brands were greater and more likely to be clinically significant. Further studies are needed to relate viscoelastic properties to force decay.

Scapula kinematic alterations following a modified push-up plus task.

Scapular kinematic and muscle activity alterations have been identified in individuals with subacromial impingement syndrome of the shoulder, including workers and athletes who regularly perform overhead activities. Serratus anterior fatigue is a proposed mechanism for these kinematic alterations, although no direct evidence supports such a relationship. The purpose of this study was to examine three-dimensional scapula kinematics in asymptomatic participants before and after a task intended to preferentially fatigue serratus anterior. Twenty-eight participants completed the study. The experimental task consisted of five repetitions of scapular plane arm elevation and the fatigue task was the isometric hold of scapular protraction in the push-up position. Electromyography of four shoulder muscles was collected during the task to determine level of muscle fatigue, and the Borg CR10 scale was used to assess subjective fatigue. The fatigue task resulted in decreased median power frequency in all four muscles and significantly increased Borg scores. Scapula posterior tilting and internal rotation were most impacted by muscle fatigue, with decreased posterior tilting and increased internal rotation after the task. There was no effect on scapular upward rotation. Effect sizes were low to moderate (.13-.51) where these kinematic alterations reached statistical significance. Shoulder muscle fatigue contributes to scapular kinematic alterations and is a plausible risk factor for subacromial impingement syndrome.

Scapular muscle activation and co-activation following a fatigue task.

Scapular muscles precisely move the scapulothoracic articulation and if fatigued may contribute to pathology. Fatigue of serratus anterior may be a mechanism for shoulder pathology by altering scapula motions and requiring compensation by other shoulder muscles. A total of 28 asymptomatic subjects performed a task to fatigue the serratus anterior, while muscle activity was recorded from three muscles. Mean normalized activation levels and activation ratios were examined before and after the fatigue task during arm elevation and lowering. All muscles demonstrated meaningful declines in the median frequency of the electromyographic signal during the task. Following the task, only the upper trapezius had higher mean activation levels (mean difference 10.79% MVIC), while the serratus anterior/lower trapezius activation ratio was altered (mean difference -0.3). Higher mean upper trapezius activation may be compensatory for fatigue of other shoulder muscles and may reflect fiber type or central control mechanisms. Serratus anterior eccentric endurance training may be beneficial for the prevention of shoulder pathology.