Dennis J. Bourbeau

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.

Real-Time Classification of Bladder Events for Effective Diagnosis and Treatment of Urinary Incontinence

Diagnosis of lower urinary tract dysfunction with urodynamics has historically relied on data acquired from multiple sensors using nonphysiologically fast cystometric filling. In addition, state-of-the-art neuromodulation approaches to restore bladder function could benefit from a bladder sensor for closed-loop control, but a practical sensor and automated data analysis are not available. We have developed an algorithm for real-time bladder event detection based on a single in situ sensor, making it attractive for both extended ambulatory bladder monitoring and closed-loop control of stimulation systems for diagnosis and treatment of bladder overactivity. Using bladder pressure data acquired from 14 human subjects with neurogenic bladder, we developed context-aware thresholding, a novel, parameterized, user-tunable algorithmic framework capable of real-time classification of bladder events, such as detrusor contractions, from single-sensor bladder pressure data. We compare six event detection algorithms with both single-sensor and two-sensor systems using a metric termed Conditional Stimulation Score, which ranks algorithms based on projected stimulation efficacy and efficiency. We demonstrate that adaptive methods are more robust against day-to-day variations than static thresholding, improving sensitivity and specificity without parameter modifications. Relative to other methods, context-aware thresholding is fast, robust, highly accurate, noise-tolerant, and amenable to energy-efficient hardware implementation, which is important for mapping to an implant device.

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.

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.

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.

Real-time, autonomous bladder event classification and closed-loop control from single-channel pressure data

Urinary incontinence, or the loss of bladder control, is a debilitating condition affecting millions worldwide, which significantly reduces quality of life. Neuromodulation of lower urinary tract nerves can be used to treat sensations of urgency in many subjects, including those with Spinal Cord Injury (SCI). Event driven, or conditional stimulation has been investigated as a possible improvement to the state-of-the-art open-loop stimulation systems available today. However, this requires a robust, adaptive, and noise-tolerant method of classifying bladder function from real-time bladder pressure measurements. Context-Aware Thresholding (CAT) has been previously shown to work well on prerecorded single contraction urodynamic data. In this work, for the first time, we present real-time detection of multiple serial bladder contractions using urodynamic recordings from human subjects with SCI and Neurogenic Detrusor Overactivity (NDO). CAT demonstrated a high degree of accuracy and noise tolerance on prerecorded data from 15 human subjects, with a mean accuracy of 92% and average false positive rate of 0.3 false positives per contraction. Analysis of event detection latencies showed that CAT identified and responded to events 1.4 seconds faster than the original human experimenter. Finally, we present a case study in which CAT was used live for real-time autonomous, closed-loop bladder control in a single human subject with SCI and NDO, successfully inhibiting four consecutive unwanted bladder contractions and increasing bladder capacity by 40%.

Ultralow-power data compression for implantable bladder pressure monitor: Algorithm and hardware implementation

Urinary incontinence, overactive bladder, and other dysfunctions of the lower urinary tract are conditions which affect millions worldwide, imposing a high financial burden and greatly affecting quality of life. Diagnosis of these conditions can be facilitated by monitoring bladder activity over time. Recent work has demonstrated the feasibility of device implantation for chronic bladder pressure monitoring, which can help to improve existing diagnostic techniques. For wireless implants, a significant portion of the implant power consumption results not from pressure sensing, but rather from data transmission. In this paper, we present a novel algorithm which is designed to perform efficient, on-chip compression of bladder pressure data with tunable quality, resulting in significant overall power savings. We validate our approach by applying the algorithm to prerecorded bladder pressure data from 14 human subjects, and demonstrate high average compression ratios (∼5x), leading to similar reductions in transmission power draw, with low reconstruction error (RMSE « 1.09). An ultralow-power hardware implementation of the proposed algorithm is obtained by synthesizing the design with TSMC 0.18 μm technology, yielding an area of 1.34 mm2 and average power of 2.3 nW using low power design techniques. To our knowledge, this is the first example of dedicated on-chip compression for bladder pressure data designed for an ultralow-power biomedical implant.

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

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.

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.

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 implants 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