Accessibility and Ease of Use in Neuromodulation Devices.

BACKGROUND: The utilization of neuromodulation therapy continues to grow as therapeutic indications expand. These conditions often present with comorbid physical, visual, and auditory impairments. Patients with disabilities in these categories may have difficulty operating their devices. Thus, reviewing the accessibility and inclusive design of neuromodulation devices is imperative to ensure equal access for patients of all ability levels. To date, the literature provides little insight into this topic. MATERIALS AND METHODS: Manufacturers of Food and Drug Administration-approved neuromodulation devices in the United States completed our electronic survey to assess neuromodulation device features, universal/inclusive design guidelines, and methods used to make the device accessible to patients with disabilities. RESULTS: We assessed 11 devices from seven manufacturers. Of those, there were six spinal cord, two peripheral nerve, and three deep brain stimulators. Of all respondents, 91% used universal inclusive design guidelines. Of the studied devices, 91% have an interface that uses visual feedback, and 82% have an interface that uses auditory feedback. All surveyed devices were reported to have an interface that requires physical handling. DISCUSSION: Our study found that most devices incorporate auditory signals, buttons with raised indentations, speech commands, or other useful features to assist those with visual disabilities. Visual interfaces may be sufficient for a patient with hearing impairment to use all the surveyed devices. However, dual sensory impairment presents a significant limitation in all devices surveyed. Furthermore, the biggest barrier to using neuromodulation devices was physical impairment because all surveyed devices require physical handling. CONCLUSIONS: Manufacturers have awareness of universal inclusive design principles. However, our study was unable to find a device that is accessible to all users regardless of ability. As such, it is critical to involve universal design principles to ensure that inclusive devices are available to improve patient adherence, treatment efficacy, and outcomes.

A review of the bioelectronic implications of stimulation of the peripheral nervous system for chronic pain conditions.

BACKGROUND: Peripheral Nerve Stimulation has been used to treat human disease including pain for several decades. Innovation has made it a more viable option for treatment of common chronic pain processes, and interest in the therapy is increasing. MAIN BODY: While clinical data is forthcoming, understanding factors that influence successful outcomes in the use of PNS still needs to be delineated. This article reviews the evolution and bioelectronic principles of peripheral nerve stimulation including patient selection, nerve targets, techniques and guidance of target delivery. We collate the current evidence for outcomes and provide recommendations for salient topics in PNS. CONCLUSION: Peripheral nerve stimulation has evolved from a surgically invasive procedure to a minimally invasive technique that can be used early in the treatment of peripheral nerve pain. This review identifies and addresses many of the variables which influence the success of PNS in the clinical setting.

Spinal cord stimulation for visceral pain from chronic pancreatitis.

BACKGROUND AND OBJECTIVES: Spinal cord stimulation (SCS) may reduce pain scores and improve function in patients with various chronic abdominal pain syndromes including chronic pancreatitis. Here described is a large clinical experience in SCS for severe chronic pancreatitis. METHODS: SCS was trialed in 30 patients with chronic pancreatitis. SCS trials lasted 7-14 days (median 9 days). SCS lead tips were mostly positioned at the T5 (N= 10) or T6 (N= 10) vertebral level. RESULTS: Twenty-four patients (80%) reported at least 50% pain relief on completion of the trial. Among these, pre-trial visual analog scale (VAS) pain scores averaged 8 ± 1.6 (standard deviation) and opioid use averaged 165 ± 120 mg morphine sulfate equivalents. During the trial, VAS pain scores decreased to 3.67 ± 2 cm (p < 0.001, Mann-Whitney Rank Sum Test) and opioid use decreased to 105 ± 101 mg morphine equivalent a day. Six patients failed the trial; one was lost to follow-up; in three patients after the implantation, the system had to be removed due to infection or lead migration; and 20 were followed for the whole year. For 20 patients followed for the whole year, VAS pain scores remained low (3.6 ± 2 cm; p < 0.001) at one year, as did opioid use (48.6 ± 58 mg morphine equivalents). CONCLUSIONS: SCS may be a useful therapeutic option for patients with severe visceral pain from chronic pancreatitis. Prospective trial is warranted.