A Flexible Implant for Multi-Day Monitoring of Colon Segment Activity.

Monitoring of colon activity is currently limited to tethered systems like anorectal manometry. These systems have significant drawbacks, but fundamentally limit the observation time of colon activity, reducing the likelihood of detecting specific clinical events. While significant technological advancement has been directed to mobile sensor capsules, this work describes the development and feasibility of a stationary sensor for describing the coordinated activity between neighboring segments of the colon. Unlike wireless capsules, this device remains in position and measures propagating pressure waves and impedances between colon segments to describe activity and motility. This low-power, flexible, wireless sensor-the colon monitor to capture activity (ColoMOCA) was validated in situ and in vivo over seven days of implantation. The ColoMOCA diameter was similar to common endoscopes to allow for minimally invasive diagnostic placement. The ColoMOCA included two pressure sensors, and three impedance-sensing electrodes arranged to describe the differential pressures and motility between adjacent colon segments. To prevent damage after placement in the colon, the ColoMOCA was fabricated with a flexible polyimide circuit board and a silicone rubber housing. The resulting device was highly flexible and suitable for surgical attachment to the colon wall. In vivo testing performed in eleven animals demonstrated suitability of both short term (less than 3 hours) and 7-day implantations. Data collected wirelessly from animal experiments demonstrated the ColoMOCA described colon activity similarly to wired catheters and allowed untethered, conscious monitoring of organ behavior.

Automated closed-loop stimulation to inhibit neurogenic bladder overactivity.

Individuals with spinal cord injury (SCI) usually develop neurogenic detrusor overactivity (NDO), resulting in bladder urgency and incontinence, and reduced quality of life. Electrical stimulation of the genital nerves (GNS) can inhibit uncontrolled bladder contractions in individuals with SCI. An automated closed-loop bladder neuromodulation system currently does not exist but could improve this approach. We have developed a custom algorithm to identify bladder contractions and trigger stimulation from bladder pressure data without need for abdominal pressure measurement. The goal of this pilot study was to test the feasibility of automated closed-loop GNS using our custom algorithm to identify and inhibit reflex bladder contractions in real time. Experiments were conducted in a single session in a urodynamics laboratory in four individuals with SCI and NDO. Each participant completed standard cystometrograms without and with GNS. Our custom algorithm monitored bladder vesical pressure and controlled when GNS was turned on and off. The custom algorithm detected bladder contractions in real time, successfully inhibiting a total of 56 contractions across all four subjects. There were eight false positives, six of those occurring in one subject. It took approximately 4.0 ± 2.6 s for the algorithm to detect the onset of a bladder contraction and trigger stimulation. The algorithm maintained stimulation for approximately 3.5 ± 1.7 s, which was enough to inhibit activity and relieve feelings of urgency. Automated closed-loop stimulation was well-tolerated and subjects reported that algorithm decisions generally matched with their perceptions of bladder activity. The custom algorithm automatically, successfully identified bladder contractions to trigger stimulation to inhibit bladder contractions acutely. Closed-loop neuromodulation using our custom algorithm is feasible, but further testing is needed refine this approach for use in a home environment.

Interdisciplinary bodyweight management program for persons with SCI.

Objective: Persons with spinal cord injury (SCI) have a higher prevalence of being overweight than the general population, which is thought to be due to a variety of metabolic, physiologic and psychological changes. The quality improvement project described in this work was designed to help overweight persons with SCI lose bodyweight through nutrition, exercise, and behavioral management strategies.Methods: Eighteen persons with SCI who were overweight were enrolled in a 12-week interdisciplinary weight management program. Participants were limited to persons at least one-year post-acute SCI with an established overweight status. Measurements, including a person's weight, body mass index, and waist circumference (WaC), were taken at the program's start, at its end, and six months post program.Results: Seventeen out of 18 participants experienced weight loss, (WaC) decreased (P < 0.001), and the program was effective at reducing weight (P < 0.001). Six months following participation in the program participants did experience a significant change in weight or waist size six months post program, thus indicating that subjects did not regain weight after completion of the program.Conclusion: This quality improvement project provided indications of the benefits of an SCI-specific interdisciplinary weight management program. Clinical research evaluating methods for helping persons with SCI achieve a healthy bodyweight is indicated.

Neural engineering: the process, applications, and its role in the future of medicine.

OBJECTIVE: Recent advances in neural engineering have restored mobility to people with paralysis, relieved symptoms of movement disorders, reduced chronic pain, restored the sense of hearing, and provided sensory perception to individuals with sensory deficits. APPROACH: This progress was enabled by the team-based, interdisciplinary approaches used by neural engineers. Neural engineers have advanced clinical frontiers by leveraging tools and discoveries in quantitative and biological sciences and through collaborations between engineering, science, and medicine. The movement toward bioelectronic medicines, where neuromodulation aims to supplement or replace pharmaceuticals to treat chronic medical conditions such as high blood pressure, diabetes and psychiatric disorders is a prime example of a new frontier made possible by neural engineering. Although one of the major goals in neural engineering is to develop technology for clinical applications, this technology may also offer unique opportunities to gain insight into how biological systems operate. MAIN RESULTS: Despite significant technological progress, a number of ethical and strategic questions remain unexplored. Addressing these questions will accelerate technology development to address unmet needs. The future of these devices extends far beyond treatment of neurological impairments, including potential human augmentation applications. Our task, as neural engineers, is to push technology forward at the intersection of disciplines, while responsibly considering the readiness to transition this technology outside of the laboratory to consumer products. SIGNIFICANCE: This article aims to highlight the current state of the neural engineering field, its links with other engineering and science disciplines, and the challenges and opportunities ahead. The goal of this article is to foster new ideas for innovative applications in neurotechnology.

Effects of Genital Nerve Stimulation Amplitude on Bladder Capacity in Spinal Cord Injured Subjects.

BACKGROUND/PURPOSE: Few studies have investigated the effects of changing the amplitude of dorsal genital nerve stimulation (GNS) on the inhibition of neurogenic detrusor overactivity in individuals with spinal cord injury (SCI). The present study determined the acute effects of changes in GNS amplitude on bladder capacity gain in individuals with SCI and neurogenic detrusor overactivity. METHODS: Cystometry was used to assess the effects of continuous GNS on bladder capacity during bladder filling. The cystometric trials were conducted in a randomized sequence of cystometric fills with continuous GNS at stimulation amplitudes ranging from 1 to 4 times of threshold (T) required to elicit the genitoanal reflex. RESULTS: The bladder capacity increased minimally and maximally by approximately 34% and 77%, respectively, of the baseline bladder capacity at 1.5 T and 3.2 T, respectively. Stimulation amplitude and bladder capacity were significantly correlated (R = 0.55, P = 0.01). CONCLUSION: This study demonstrates a linear correlation between the stimulation amplitude ranging from 1 to 4T and bladder capacity gain in individuals with SCI in acute GNS experiments. However, GNS amplitude out of the range of 1-4T might not be exactly a linear relationship due to subthreshold or saturation factors. Thus, further research is needed to examine this issue. Nevertheless, these results may be critical in laying the groundwork for understanding the effectiveness of acute GNS in the treatment of neurogenic detrusor overactivity.

At-home genital nerve stimulation for individuals with SCI and neurogenic detrusor overactivity: A pilot feasibility study.

OBJECTIVE: Neurogenic bladder dysfunction, including neurogenic detrusor overactivity (NDO) is one of the most clinically significant problems for persons with spinal cord injury (SCI), affecting health and quality of life. Genital nerve stimulation (GNS) can acutely inhibit NDO-related reflex bladder contractions and increase bladder capacity. However, it is unknown if GNS can improve urinary continence or help meet individuals' bladder management goals during sustained use, which is required for GNS to be clinically effective. DESIGN: Subjects maintained voiding diaries during a one-month control period without stimulation, one month with at-home GNS, and one month after GNS. Urodynamics and quality of life assessments were conducted after each treatment period, and a satisfaction survey was taken at study completion. SETTING: Subject screening and clinical procedures were conducted at the Louis Stokes Cleveland VA Medical Center. Stimulation use and voiding diary entries were conducted in subjects' homes. PARTICIPANTS: Subjects included five men with SCI and NDO. INTERVENTIONS: This study tested one month of at-home portable non-invasive GNS. OUTCOME MEASURES: The primary outcome measure was leakage events per day. Secondary outcome measures included self-reported subject satisfaction, bladder capacity, and stimulator use frequency. RESULTS: GNS reduced the number of leakage events from 1.0 ± 0.5 to 0.1 ± 0.4 leaks per day in the four subjects who reported incontinence data. All study participants were satisfied that GNS met their bladder goals; wanted to continue using GNS; and would recommend it to others. CONCLUSIONS: Short term at-home GNS reduced urinary incontinence and helped subjects meet their bladder management goals. These data inform the design of a long-term clinical trial testing of GNS as an approach to reduce NDO.

An Interdisciplinary Approach to Reducing Opioid Prescriptions to Patients with Chronic Pain in a Spinal Cord Injury Center.

BACKGROUND: The increasing use of prescription opioids has contributed to the epidemic of opioid abuse in the United States. Efforts to reduce opioid prescriptions and offer alternatives for pain management are needed. OBJECTIVE: To determine the success of a multidisciplinary project to manage chronic pain while reducing reliance on opioids in a population of patients with spinal cord injury (SCI). DESIGN: Retrospective analysis. SETTING: This study was conducted in an SCI system of care in northeast Ohio. PARTICIPANTS: Individuals with SCI receiving outpatient care were included. INTERVENTIONS: Clinicians in SCI and pain management specialties developed a plan to manage individuals with SCI, particularly for individuals using opioids, including physical, occupational, recreational, and vocational therapy. These services worked closely with the SCI physicians when chronic pain was identified to help better medically manage their pathology and support efforts to decrease opioid use in a multipronged approach. MAIN OUTCOMES: The primary outcome measures from opioid prescription data from 2008 to 2016 were the percent of outpatients receiving opioids, opioid prescription rates, and opioid prescription doses over time. RESULTS: The percentage of outpatients receiving opioids and the number of opioid prescriptions through the outpatient service significantly decreased, from 39% to 16% and from 2.5 to 1.5 prescriptions per patient per quarter, respectively, correlating with the introduction of the multidisciplinary interventions. The total morphine equivalent quantities of prescription medications, particularly nonmethadone opioids, also decreased significantly. CONCLUSIONS: The multidisciplinary interventional approach was associated with marked decreases in the percentage of patients receiving opioids and the amounts of opioids being prescribed. This reduction could have a significant impact on the opioid crisis. LEVEL OF EVIDENCE: IV.

Genital nerve stimulation is tolerable and effective for bladder inhibition in sensate individuals with incomplete SCI.

BACKGROUND: Neurogenic detrusor overactivity after spinal cord injury (SCI) causes urinary incontinence and reduces bladder capacity. Surface electrical genital nerve stimulation (GNS) acutely inhibits reflex bladder contractions. The stimulation amplitude selected for GNS is typically twice the amplitude that is required to evoke the pudendal-anal reflex. There is concern about the ability of persons with sensation to comfortably tolerate effective levels of GNS. The objective of this work is to determine if persons with incomplete SCI are able to tolerate acute GNS for bladder inhibition. METHODS: Twenty-four subjects with neurogenic detrusor overactivity, SCI, and pelvic sensation were enrolled in this case series. The setting was the Spinal Cord Injury Service of a Veterans Affairs Medical Center. Primary outcome measures were sensation threshold and tolerable stimulation amplitude; secondary outcome measures were bladder capacity and bladder contraction inhibition. RESULTS: GNS was tolerable up to 30±16 mA (range 8 mA to ≥60 mA) at amplitudes greater than twice the pudendal-anal (PA) reflex threshold, which was 8±5 mA (range 4 mA to 20 mA). Twelve subjects tolerated GNS at greater than twice the PA, six tolerated 1-1.5 times the PA, and five had no identifiable PA. GNS at tolerable amplitudes inhibited reflexive bladder contractions or increased bladder capacity 135±109 mL (n=23). GNS did not cause autonomic dysreflexia or intolerable spasticity. CONCLUSIONS: GNS is tolerable at amplitudes that effectively inhibit neurogenic detrusor overactivity in individuals with pelvic sensation. GNS therefore is a tool with potential clinical applications for persons with preserved sensation.

Genital nerve stimulation increases bladder capacity after SCI: A meta-analysis.

BACKGROUND: Neurogenic detrusor overactivity (NDO) often results in decreased bladder capacity, urinary incontinence, and vesico-ureteral reflux. NDO can trigger autonomic dysreflexia and can impair quality of life. Electrical stimulation of the genital nerves (GNS) acutely inhibits reflex bladder contractions and can increase bladder capacity. Quantifying the effect of GNS on bladder capacity and determining what study factors and subject factors influence bladder capacity improvements will inform the design of clinical GNS interventions. METHODS: We measured bladder capacity in 33 individuals with NDO, with and without GNS. These data were combined with data from seven previous GNS studies (n=64 subjects). A meta-analysis of the increase in bladder capacity and potential experimental factors was conducted (n=97 subjects total). RESULTS: Bladder capacity increased 131±101 ml with GNS across subjects in all studies. The number of individuals whose bladder capacity was greater than 300 ml increased from 24% to 62% with GNS. Stimulus amplitude was a significant factor predicting bladder capacity gain. The variance of the bladder capacity gain significantly increased with increasing infusion rate. Other factors did not contribute to bladder capacity gain. CONCLUSION: GNS acutely increases bladder capacity in individuals with NDO. The consistent increase in magnitude of bladder capacities across the eight studies, and the lack of dependence on individual-specific factors, provide confidence that GNS could be an effective tool for many individuals with NDO. Studies of the chronic effect of GNS on bladder control, with clinical measures such as urinary continence, are needed.

The neural response properties and cortical organization of a rapidly adapting muscle sensory group response that overlaps with the frequencies that elicit the kinesthetic illusion.

Kinesthesia is the sense of limb movement. It is fundamental to efficient motor control, yet its neurophysiological components remain poorly understood. The contributions of primary muscle spindles and cutaneous afferents to the kinesthetic sense have been well studied; however, potential contributions from muscle sensory group responses that are different than the muscle spindles have not been ruled out. Electrophysiological recordings in peripheral nerves and brains of male Sprague Dawley rats with a degloved forelimb preparation provide evidence of a rapidly adapting muscle sensory group response that overlaps with vibratory inputs known to generate illusionary perceptions of limb movement in humans (kinesthetic illusion). This group was characteristically distinct from type Ia muscle spindle fibers, the receptor historically attributed to limb movement sensation, suggesting that type Ia muscle spindle fibers may not be the sole carrier of kinesthetic information. The sensory-neural structure of muscles is complex and there are a number of possible sources for this response group; with Golgi tendon organs being the most likely candidate. The rapidly adapting muscle sensory group response projected to proprioceptive brain regions, the rodent homolog of cortical area 3a and the second somatosensory area (S2), with similar adaption and frequency response profiles between the brain and peripheral nerves. Their representational organization was muscle-specific (myocentric) and magnified for proximal and multi-articulate limb joints. Projection to proprioceptive brain areas, myocentric representational magnification of muscles prone to movement error, overlap with illusionary vibrational input, and resonant frequencies of volitional motor unit contraction suggest that this group response may be involved with limb movement processing.

Tunable and Lightweight On-Chip Event Detection for Implantable Bladder Pressure Monitoring Devices.

Lower urinary tract dysfunctions, such as urinary incontinence and overactive bladder, are conditions that greatly affect the quality of life for millions of individuals worldwide. For those with more complex pathophysiologies, diagnosis of these conditions often requires a urodynamics study, providing physicians with a snapshot view of bladder mechanics. Recent advancements in implantable bladder pressure monitors and advanced data analysis techniques have made diagnosis through chronic monitoring a promising prospect. However, implants targeted at treatment must remain in the bladder for long periods of time, making minimizing power consumption a primary design objective. Currently, much of the typical implant's power draw is due to data transmission. Previous work has demonstrated an adaptive rate transmission technique to reduce power consumption. However, the ultimate reduction in power consumption can only be attained when the device does not transmit bladder pressure samples, but rather bladder events. In this paper, we present an algorithm and circuit level implementation for on-chip bladder pressure data compression and event detection. It is designed to be a complete, tunable, and lightweight diagnosis and treatment framework for bladder pressure monitoring implants, capable of selectively transmitting compressed bladder pressure data with tunable quality, "snapshots" of significant bladder events, or simply indicate events occurred for the highest energy efficiency. The design aims to minimize area through resource reuse, leading to a total area of 1.75 , and employs advanced VLSI techniques for power reduction. With compression and event detection enabled, the design consumes roughly 2.6 nW in TSMC technology. With only event detection, this reduces to 2.1 nW, making this approach ideal for long-life implantable bladder pressure monitoring devices.

Ultrasound-Guided Steroid Injection of the Pisotriquetral Joint: A Multidisciplinary Effort.

From the perspective of a multidisciplinary team, the authors describe the first reported use of ultrasound guidance for steroid injection into the pisotriquetral joint to relieve wrist pain of a person with spinal cord injury undergoing acute inpatient rehabilitation. Musculoskeletal ultrasound guidance was used to improve the accuracy of a corticosteroid injection of the pisotriquetral joint and the basal thumb in a 70-year-old man with paraplegia experiencing multifocal degenerative wrist pain. There was no bleeding or bruising after the injections, and the patient reported complete pain resolution 1 wk after the injections, which continued for over 1 yr. A multidisciplinary team was key in diagnosis, selection of treatment, and evaluation of treatment effect. Corticosteroid injection of the pisotriquetral joint under ultrasound guidance can be used as a treatment modality for managing wrist pain stemming from that joint. Further investigation and studies evaluating the use of ultrasound versus other imaging modalities for injection of the wrist are indicated.

Functional electrical stimulation and spinal cord injury.

Spinal cord injuries (SCI) can disrupt communications between the brain and the body, resulting in loss of control over otherwise intact neuromuscular systems. Functional electrical stimulation (FES) of the central and peripheral nervous system can use these intact neuromuscular systems to provide therapeutic exercise options to allow functional restoration and to manage medical complications following SCI. The use of FES for the restoration of muscular and organ functions may significantly decrease the morbidity and mortality following SCI. Many FES devices are commercially available and should be considered as part of the lifelong rehabilitation care plan for all eligible persons with SCI.