Stimulation Device Research Articles

Epilepsy first aid awareness among healthcare workers in Saudi Arabia: A cross-sectional study.

Epilepsy is a neurological disorder affecting more than 50 million human lives of all ages, its social, physical and psychological implications is of huge concern. The current study and as a continuation of epilepsy knowledge assessment projects conducted by our research team is aimed to assess the knowledge of healthcare workers regarding epilepsy first aid in Saudi Arabia. A cross-sectional questionnaire-based study was carried out from 2020 to 2021. During the study period, 272 healthcare workers were recruited; participants were males and females from different nationalities in various Saudi Arabian cities, possess diverse qualifications, and belong to several healthcare-related professions. The question, "Did you witness an epileptic seizure"? was answered as "Yes" by 42% of participants, and in response to the question "If you know that this patient struggles during seizure attacks," 58% of respondents stated that they would not call an ambulance. Moreover, the question "Put something in his/her mouth to prevent tongue biting" was incorrectly answered as "Yes" by 42% of respondents, and the question "Try to catch him/her and stop his/her movement" in order to control the attack was answered "Yes" by 21% of respondents. Furthermore, almost 90% of healthcare participants do not know how to use the Vagus Nerve Stimulation device. The mean knowledge score among participants was 23.7; sex, as well as type of higher qualification obtained, was found to be significantly associated with the score of knowledge. Knowledge toward epilepsy and epilepsy first aid among healthcare workers in Saudi Arabia was found fragile. Further research is appreciated to support the current findings.

Design and Testing of a Compact, Portable Single-Pulse Transcranial Magnetic Stimulation Device

Design and Testing of a Compact, Portable Single-Pulse Transcranial Magnetic Stimulation Device

Use of the transfemoral access approach for cardiac stimulation device implantation when the superior venous approach is not feasible: A single-centre twenty-year series

Background: When permanent cardiac stimulation device implantation via superior venous access (i.e., cephalic, axillary or subclavian veins) is not possible or advisable, safe and feasible surgical alternatives must be used. The transfemoral approach is relatively unknown; therefore, it is seldom used and studied. This single-centre study analysed the 20-year outcomes of patients who underwent implantation using a transfemoral implantation approach. Methods: Data on the implantation procedure (indication, approach, lead and pacemaker models, complications), patient characteristics (age, sex, medications, comorbidities), and follow-up were analysed for all patients who underwent permanent cardiac stimulation device implantation using the transfemoral approach between June 2001 and December 2021. Results: A permanent cardiac stimulation device was implanted using the transfemoral approach in 66 patients (mean age, 76 years [range: 45-96], 40 [60%] men). The most frequent indication was atrioventricular block, associated with sinus rhythm in 36 patients and atrial fibrillation in 11 patients. The mean implantation time was 61 min (range: 20-210), and the mean fluoroscopy time was 7.9 min (range: 0.2-87). The minimum follow-up period was one year (December 2022), with a mean of 60 months [range: 2-180]). Overall, 26 patients (42%) were treated with oral anticoagulants postimplantation. No deaths, septic episodes, or severe complications were associated with the procedure in the short or long term. Follow-up data were available for 64 patients, of whom 52 (81%) died during follow-up (mean age, 84 years [range: 55-101]). No deaths were associated with the use of the transfemoral technique. Conclusions: Permanent cardiac stimulation device implantation using the transfemoral access approach is feasible and straightforward for an experienced implant surgeon. The outcomes of systems implanted by the transfemoral access approach were comparable to those of systems implanted by the superior venous approach, and no severe complications were observed at the 20-year follow-up.

Advances in Non-Invasive Neuromodulation: Designing Closed-Loop Devices for Respiratory-Controlled Transcutaneous Vagus Nerve Stimulation.

Studies suggest non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) as a potential therapeutic option for various pathological conditions, such as epilepsy and depression. Exhalation-controlled taVNS, which synchronizes stimulation with internal body rhythms, holds promise for enhanced neuromodulation, but there is no closed-loop system in the literature capable of performing such integration in real time. In this context, the objective was to develop real-time signal processing techniques and an integrated closed-loop device with sensors to acquire physiological data. After a conditioning stage, the signal is processed and delivers synchronized electrical stimulation during the patient's expiratory phase. Additional modules were designed for processing, software-controlled selectors, remote and autonomous operation, improved analysis, and graphical visualization. The signal processing method effectively extracted respiratory cycles and successfully attenuated signal noise. Heart rate variability was assessed in real time, using linear statistical evaluation. The prototype feedback stimulator device was physically constructed. Respiratory peak detection achieved an accuracy of 90%, and the real-time processing resulted in a small delay of up to 150 ms in the detection of the expiratory phase. Thus, preliminary results show promising accuracy, indicating the need for additional tests to optimize real-time processing and the application of the prototype in clinical studies.

Wireless Deep Brain Stimulation by Ultrasound-Responsive Molecular Piezoelectric Nanogenerators.

Implantable neural stimulation devices are becoming prevalent in bioelectronic medicine for the precise treatment of various clinical diseases. Nevertheless, the limited lifespan and buckling size of the implanted devices remain significant obstacles for chronic clinical application. In this study, we developed an ultrasound-driven battery-free neurostimulator based on a high-performance mini-sized nanogenerator and demonstrated its successful application for the deep-brain-stimulation (DBS) therapy of Parkinson's disease in a rat model. This soft piezoelectric-triboelectric hybrid nanogenerators (PTNG) are made of porous thin-films of molecular piezoelectric materials, which have great advantages of facile, scalable, low-temperature, and flexible processing. Without any bucky accessory control circuits, the subcutaneously implanted soft PTNG can function as a wirelessly powered neurostimulator, allowing for the adjustment of stimulation parameters through external programmable ultrasound pulses. This DBS electroceutical application of energy-harvesting thin-film devices based on molecular piezoelectric materials provides valuable insight into the development of a soft high-performance bioelectronic device.

Millimetric devices for nerve stimulation: a promising path towards miniaturization.

Nerve stimulation is a rapidly developing field, demonstrating positive outcomes across several conditions. Despite potential benefits, current nerve stimulation devices are large, complicated, and are powered via implanted pulse generators. These factors necessitate invasive surgical implantation and limit potential applications. Reducing nerve stimulation devices to millimetric sizes would make these interventions less invasive and facilitate broader therapeutic applications. However, device miniaturization presents a serious engineering challenge. This review presents significant advancements from several groups that have overcome this challenge and developed millimetric-sized nerve stimulation devices. These are based on antennas, mini-coils, magneto-electric and opto-electronic materials, or receive ultrasound power. We highlight key design elements, findings from pilot studies, and present several considerations for future applications of these devices.

A perspective on translating genomic discoveries into targets for brain-machine interface and deep brain stimulation devices.

Mental illnesses have a huge impact on individuals, families, and society, so there is a growing need for more efficient treatments. In this context, brain-computer interface (BCI) technology has the potential to revolutionize the options for neuropsychiatric therapies. However, the development of BCI-based therapies faces enormous challenges, such as power dissipation constraints, lack of credible feedback mechanisms, uncertainty of which brain areas and frequencies to target, and even which patients to treat. Some of these setbacks are due to the large gap in our understanding of brain function. In recent years, large-scale genomic analyses uncovered an unprecedented amount of information regarding the biology of the altered brain function observed across the psychopathology spectrum. We believe findings from genetic studies can be useful to refine BCI technology to develop novel treatment options for mental illnesses. Here, we assess the latest advancements in both fields, the possibilities that can be generated from their intersection, and the challenges that these research areas will need to address to ensure that translational efforts can lead to effective and reliable interventions. Specifically, starting from highlighting the overlap between mechanisms uncovered by large-scale genetic studies and the current targets of deep brain stimulation treatments, we describe the steps that could help to translate genomic discoveries into BCI targets. Because these two research areas have not been previously presented together, the present article can provide a novel perspective for scientists with different research backgrounds. This article is categorized under: Neurological Diseases > Genetics/Genomics/Epigenetics Neurological Diseases > Biomedical Engineering.

Effect of transcranial static magnetic stimulation over unilateral or bilateral motor association cortex on performance of simple and choice reaction time tasks.

Transcranial static magnetic stimulation (tSMS) is a non-invasive brain stimulation technique that place a strong neodymium magnet on scalp to reduce cortical excitability. We have recently developed a new tSMS device with three magnets placed close to each other (triple tSMS) and confirmed that this new device can produce a stronger and broader static magnetic field than the conventional single tSMS. The aim of the present study was to investigate the effect of the conventional single tSMS as well as triple tSMS over the unilateral or bilateral motor association cortex (MAC) on simple and choice reaction time (SRT and CRT) task performance. There were two experiments: one involved the conventional tSMS, and the other involved the triple tSMS. In both experiments, right-handed healthy participants received each of the following stimulations for 20 min on different days: tSMS over the unilateral (left) MAC, tSMS over the bilateral MAC, and sham stimulation. The center of the stimulation device was set at the premotor cortex. The participants performed SRT and CRT tasks before, immediately after, and 15 min after the stimulation (Pre, Post 0, and Post 15). We evaluated RT, standard deviation (SD) of RT, and accuracy (error rate). Simulation was also performed to determine the spatial distribution of magnetic field induced by tSMS over the bilateral MAC. The spatial distribution of induced magnetic field was centered around the PMd for both tSMS systems, and the magnetic field reached multiple regions of the MAC as well as the sensorimotor cortices for triple tSMS. SD of CRT was significantly larger at Post 0 as compared to Pre when triple tSMS was applied to the bilateral MAC. No significant findings were noted for the other conditions or variables. We found that single tSMS over the unilateral or bilateral MAC did not affect performance of RT tasks, whereas triple tSMS over the bilateral MAC but not over the unilateral MAC increased variability of CRT. Our finding suggests that RT task performance can be modulated using triple tSMS.

"O" no: a Reddit analysis of orgasmic dysfunction.

Female Reddit users frequently discussed potential causes of orgasm difficulties and its implications on mental health and relationships. This study aimed to evaluate the experiences of women discussing orgasms on the Internet site Reddit. We sought to qualitatively analyze the topics that arose in users' discussions to better understand the potential causes of orgasm difficulties and its implications on quality of life. Posts on the subreddit r/TwoXChromosomes containing the keywords "orgasm" and "climax" were included in the dataset. Posts and their associated comments were qualitatively analyzed using the grounded theory approach. Two independent researchers coded each thread to identify dominant themes and emergent concepts. The most frequently coded primary topics included: (1) orgasm (32.2% [n = 337]), (2) psychological (17.8% [n = 186]), (3) relationships (15.4% [n = 161]), and (4) treatment (10.7% [n = 112]). Qualitative analysis of 107 threads and approximately 6300 comments resulted in 5 major categories: psychological aspect of orgasms, difficulty orgasming with partners, partners' responses to orgasmic dysfunction, types of orgasms, and treatments for orgasmic dysfunction. Preliminary themes included (1) the presence of an emotional component or history of trauma related to orgasmic difficulty, (2) difficulty orgasming with a partner regardless of ability to orgasm during masturbation and a variety of stimulation required to orgasm, (3) mixed partner responses to orgasmic dysfunction, (4) the definition of a normal orgasm, and (5) self-motivated treatment for orgasmic dysfunction, including clitoral stimulation devices and masturbation techniques. Notably, few posters discussed their orgasmic dysfunction with healthcare providers. The study reveals insights into the possible causes, psychosocial implications, and treatment of orgasm difficulties from a patient perspective, and can guide future research on female orgasms in a more precise, patient-oriented direction. The anonymous nature of the forum allowed for insight into sensitive topics related to female orgasms and sexual trauma. Limitations include the demographic distribution of Reddit users, which was primarily younger women in their 20s and 30s, which restricts generalizability. Reddit provides a medium for individuals with orgasm difficulties to discuss their experiences. Posts addressed users' inability to orgasm, their mental health and relationships, the stimulation required for orgasm, and treatments for orgasmic dysfunction. Interestingly, very few posts discussed healthcare, potentially suggesting that women do not classify their orgasmic dysfunction as a health issue.

Health-related quality of life and spinal cord stimulation in painful diabetic neuropathy

Peripheral neuropathic pain, including painful diabetic neuropathy (PDN), is associated with marked negative impact on health-related quality of life (HRQoL). The magnitude of reduction of HRQoL experienced by individual PDN patients appears to be strongly associated with their level of pain and disease severity. In spite of the availability of a range of pharmacotherapy, a substantive proportion of PDN patients continue to experience suboptimal HRQoL. Such patients are potential candidates for spinal cord stimulation (SCS) devices. Three randomised controlled trials in over 300 patients with refractory PDN have shown that the addition of SCS to standard of care therapy results in important health gains, including pain reduction and enhancement of HRQoL. Sham-controlled RCTs that enable blinding of patients, clinicians and researchers are needed to confirm the role of SCS in PDN.

Hypoglossal nerve stimulation for adults with obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a common chronic condition in which upper airway collapse interferes with breathing during sleep, reducing sleep quality. Untreated OSA can impair a patient's health and quality of life. The recommended first-line treatment for OSA in adults is positive airway pressure, but difficulty tolerating this device limits adherence to treatment for many patients. Treatment with an implanted hypoglossal nerve stimulation (HNS) device is a relatively new second-line option for these patients, and is gaining more widespread use. Clinicians who treat OSA or provide other healthcare services to patients with HNS implants should be familiar with these devices. This article reviews HNS technology and relevant OSA pathophysiology, along with device candidacy criteria, efficacy, risks, and considerations related to use of other medical technologies for patients with HNS implants.

Beyond Hypoglossal Hype: Social Media Perspectives on the Inspire Upper Airway Stimulation System

In the landscape of sleep surgery, the Inspire® Upper Airway Stimulation (UAS) device has gained prominence as an increasingly popular treatment option for obstructive sleep apnea, prompting significant discourse across social media platforms. This study explores the social media narrative of the UAS device, particularly the nature of multimedia content, author demographics, and audience engagement on Instagram, Facebook, and TikTok. Our analysis encompassed 423 public posts, revealing images (67.4%) and videos (28.1%) as the dominant content types, with over a third of posts authored by physicians. A notable 40% of posts were advertisements, whereas patient experiences comprised 34.5%. TikTok, although presenting a smaller sample size, showed a substantially higher engagement rate, with posts averaging 152.9 likes, compared with Instagram and Facebook at 32.7 and 41.2 likes, respectively. The findings underscore the need for otolaryngologists and healthcare professionals to provide clear, evidence-based information on digital platforms. Given social media’s expanding role in healthcare, medical professionals must foster digital literacy and safeguard the accuracy of health information online. In this study, we concluded that maintaining an evidence-based, transparent digital dialogue for medical innovations such as the UAS device necessitates collaborative efforts among physicians, health institutions, and technology companies.

Poster Session I: Binocular facilitation of the BOLD response to melanopsin stimulation in the suprachiasmatic nucleus.

In a recent analysis of archival data, Spitschan and Cajochen (2019) identify what appears to be substantial binocular facilitation of melatonin suppression due to melanopic light stimulation. This putative effect likely originates in the melanopsin-containing intrinsically photosensitive retinal ganglion cells (ipRGCs) which project directly to the suprachiasmatic nucleus (SCN) of the hypothalamus. We asked whether we could measure a direct physiological correlate of this binocular facilitation using a binocular, MRI-compatible, 10-primary spectral stimulation device. We present preliminary findings from a functional magnetic resonance imaging (fMRI) study designed to explore the blood oxygen level dependent (BOLD) response to monocular and binocular melanopic light stimulation. The study used a 30 s on/off design with three 'ocularity' conditions (binocular-low, monocular-high, binocular-high) and two classes of targeted photoreceptors (melanopsin and LMS cones). Throughout each scan, subjects (N=18) also responded to brief, cone-directed sinusoidal modulations of varying intensity. We report that binocular vs. monocular melanopsin stimulation induced significant BOLD activation in SCN but that this effect was not seen for cone-directed stimulation. This is consistent with the binocular facilitation effect described by Spitschan and Cajochen (2019) and provides the first direct evidence of melanopsin-driven activation and binocular facilitation in human subcortical nuclei.

Taking Control: A Novel Galvanic Stimulation Device for the Visually Impaired.

The white cane has been the prominent and widely used mobility aid by visually impaired persons for many years, however, there are some limitations associated with the white cane mobility aid device. Primarily, the white cane exhibits restricted capability in detecting ground-level obstacles in proximity and does not provide reliable detection of aerial obstacles. Our work proposes a device for the safe navigation of visually impaired persons utilizing a non-invasive galvanic vestibular stimulation (GVS) technique. By delivering a signal (1-1.2mA) delivered behind the ear via electrode pads to the vestibular system, we induce a sensation of steering thereby facilitating navigation. Our proposed device utilizes a combination of Intel’s D435 depth camera and an object detection model, YOLOv5, to identify and process the detection of obstacles within a 3-meter range. Within 0.2 seconds, the object is detected, and the algorithm assesses the situation and sends instructions via User Datagram Protocol (UDP) packets wirelessly to the GVS device. The device receives the packets and steers the subject (human) autonomously. In total, four tests with different scenarios have been conducted, through experimentation, it was found that the system could successfully detect, process, and transmit geospatial information to the GVS module; and steers the user into the correct trajectory to avoid any hazards obstructing the user’s path.

Osteogenesis Stimulator Devices Reduce Surgical Intervention, Opioid Utilization, and Overall Costs in Patients with Fracture Nonunions.

Approximately 10% of fractures result in delayed union or nonunion. These cases result in pain and disability as well as increased utilization of healthcare resources such as pain medication, physical therapy, and subsequent surgery. Osteogenesis stimulator devices are a safe and low-cost, non-invasive option to aid healing in nonunion cases. Study objectives aimed to evaluate real-world data of osteogenesis stimulator device usage in a variety of healthcare utilization endpoints including surgical intervention for nonunion, pain medication use, and overall healthcare costs. Data were stratified into three groups: the Stim Device group and the No Stim and Surgical control groups. A retrospective analysis of a large claims-based database was conducted. The database was queried for adult patients having a diagnosis of nonunion, with evidence of a prior fracture in the previous 180 days (n = 11,010). The osteogenesis stimulator group (Stim Device group, n = 1,628) was defined as those patients having at least one claim for an osteogenesis stimulator in the period 90 to 180 days following fracture and up to 60 days following the nonunion diagnosis. The control group (No Stim group, n = 9,382) had a nonunion diagnosis with evidence of a fracture in the prior 180 days but did not receive a device. A total of 1,751 patients from the No Stim group were sub-grouped into surgical/operative controls (No Stim - Surgical group). Stim Device patients showed lower rates of surgical intervention for their bone nonunion compared to the No Stim patients (214/1,628, 13.1% vs.1,751/9,382, 18.7%, p < 0.001). Stim Device patients had lower rates of opioid utilization post-index compared to No Stim patients (948/1,628, 58.2% vs.6,359/9,382, 67.8%, p < 0.001). Overall healthcare costs were significantly reduced in the Stim Device group ($21,654) compared with No Stim ($29,101; p < 0.001) and Surgical ($35,914; p < 0.001) control groups. The results show that bone growth stimulator devices have a positive individual and societal impact on treating patients with fracture nonunions.

Oscillatory Responses to Tactile Stimuli of Different Intensity.

Tactile perception encompasses several submodalities that are realized with distinct sensory subsystems. The processing of those submodalities and their interactions remains understudied. We developed a paradigm consisting of three types of touch tuned in terms of their force and velocity for different submodalities: discriminative touch (haptics), affective touch (C-tactile touch), and knismesis (alerting tickle). Touch was delivered with a high-precision robotic rotary touch stimulation device. A total of 39 healthy individuals participated in the study. EEG cluster analysis revealed a decrease in alpha and beta range (mu-rhythm) as well as theta and delta increase most pronounced to the most salient and fastest type of stimulation. The participants confirmed that slower stimuli targeted to affective touch low-threshold receptors were the most pleasant ones, and less intense stimuli aimed at knismesis were indeed the most ticklish ones, but those sensations did not form an EEG cluster, probably implying their processing involves deeper brain structures that are less accessible with EEG.

Changes in vestibular-related responses to combined noisy galvanic vestibular stimulation and cerebellar transcranial direct current stimulation.

Vestibular nuclei and cerebellar function comprise vestibular neural networks that control vestibular-related responses. However, the vestibular-related responses to simultaneous stimulation of these regions are unclear. This study aimed to examine whether the combination of noisy galvanic vestibular stimulation (nGVS) and cerebellar transcranial direct current stimulation (ctDCS) using a complex transcranial electrical stimulation device alters vestibular-dominant standing stability and vestibulo-ocular reflex (VOR) function. The center of foot pressure (COP) sway and VOR of participants (28 healthy, young adults) were assessed under four conditions of transcranial electrical stimulation using nGVS and ctDCS. The COP was calculated with the participant standing on a soft-foam surface with eyes closed using a force plate to evaluate body sway. VOR measurements were collected via passive head movements and fixation on a target projected onto the front wall using a video head impulse test (vHIT). VOR gain was calculated in six directions using a semicircular canal structure based on the ratio of eye movement to head movement. The nGVS + ctDCS and nGVS + sham ctDCS conditions decreased COP sway compared to the sham nGVS + ctDCS and sham nGVS + sham ctDCS conditions. No significant differences were observed in the main effect of stimulation or the interaction of stimulation and direction on the vHIT parameters. The results of this study suggest that postural stability may be independently affected by nGVS. Our findings contribute to the basic neurological foundation for the clinical application of neurorehabilitation using transcranial electrical stimulation of the vestibular system.

Mitigating Infection Risk in Upper Airway Stimulation.

This study aims to define the incidence of infection with upper airway stimulation (UAS) devices requiring explantation in a single academic center and identify factors that may influence the risk of infection. A database of patients who underwent UAS at a single tertiary referral academic center from 2017 to 2021 was retrospectively reviewed to identify patients who developed surgical site infections, with and without subsequent explantation. Additional data for cases complicated by infection was extracted from the electronic medical record (EMR) and included: demographic information, medical history, complications and management, and overall outcomes. In March 2021, 2 modifications to infection control protocols were implemented: double skin preparation with Betadine and chlorhexidine, and MRSA decolonization. Statistical analysis was performed to compare infectious risk before and after these protocol changes. In the study period, 215 patients underwent UAS in the specified time period and 3 cases (1.4%) of postoperative infections were identified, all of which required explantation. The infection rate did not significantly change after modifications to the surgical prep protocol (P = .52). While no significant difference in infection risk was noted after modifying infection control protocols, additional longer-term study is warranted to elucidate effective infection reduction strategies.

Multimodal Gamma Stimulation Improves Activity but not Memory in Aged Tgf344-AD Rats.

Multimodal sensory gamma stimulation is a treatment approach for Alzheimers disease that has been shown to improve pathology and memory in transgenic mouse models of Alzheimer's. Because rats are closer to humans in evolution, we tested the hypothesis that the transgenic rat line bearing human APP and PS1, line TgF344-AD, would be a good supplemental candidate to test the efficacy of this treatment. Current therapy approaches under investigation seek to utilize the immune response to minimize or degrade the accumulation of β-amyloid plaque load in mouse models designed to overexpress Aβ. However, many of these models lack some of the hallmarks of Alzheimer's disease, such as hyperphosphorylated tau and neuronal cell loss. The TgF344-AD transgenic rat model is a good candidate to bridge the gap between mouse models and clinical efficacy in humans. The objective of this study was to use multimodal gamma stimulation at light and auditory modalities simultaneously to test whether this enhances memory performance as measured by the object location task and the spontaneous alternation task. In our study, we designed and built a low-cost, easy-to-construct multimodal light and sound gamma stimulator. Our gamma stimulation device was built using an Arduino microcontroller, which drives lights and a speaker at the gamma frequency. We have included in this paper our device's parts, hardware design, and software architecture for easy reproducibility. We then performed an experiment to test the effect of multimodal gamma stimulation on the cognitive performance of fourteen-month-old TgF344-AD rats. Rats were randomly assigned to either an experimental group that received gamma stimulation or a control group that did not. Performance in a Novel Object Location (NOL) task and spontaneous alternation task was evaluated in both groups before and after the treatment. Multimodal gamma stimulation did not improve memory compared to unstimulated TgF344-AD rats. However, the gamma-stimulated rats did spend significantly more time exploring objects in the novel location task than the unstimulated rats. In the spontaneous alternation task, gamma-stimulated rats exhibited significantly greater exploratory activity than unstimulated controls. Multimodal gamma stimulation did not enhance memory performance in the object location task or the spontaneous alternation task. However, in both tasks, the treatment group had improved measures of exploratory activity relative to the untreated group. We conclude that several limitations could have contributed to this mixed effect, including aging complications, different animal models, or light cycle effects.

Noninvasive Bioelectronic Treatment of Postcesarean Pain

Improved strategies are needed to decrease opioid use after cesarean delivery but still adequately control postoperative pain. Although transcutaneous electrical stimulation devices have proven effective for pain control after other surgical procedures, they have not been tested as part of a multimodal analgesic protocol after cesarean delivery, the most common surgical procedure in the United States. To determine whether treatment with a noninvasive high-frequency electrical stimulation device decreases opioid use and pain after cesarean delivery. This triple-blind, sham-controlled randomized clinical trial was conducted from April 18, 2022, to January 31, 2023, in the labor and delivery unit at a single tertiary academic medical center in Ohio. Individuals were eligible for the study if they had a singleton or twin gestation and underwent a cesarean delivery. Of 267 people eligible for the study, 134 (50%) were included. Participants were randomly assigned in a 1:1 ratio to a high-frequency (20 000 Hz) electrical stimulation device group or to an identical-appearing sham device group and received 3 applications at the incision site in the first 20 to 30 hours postoperatively. The primary outcome was inpatient postoperative opioid use, measured in morphine milligram equivalents (MME). Secondary outcomes included pain scores, measured with the Brief Pain Inventory questionnaire (scale, 0-10, with 0 representing no pain), MME prescribed at discharge, and receipt of additional opioid prescriptions in the postpartum period. Normally distributed data were assessed using t tests; otherwise via Mann-Whitney or χ2 tests as appropriate. Analyses were completed following intention-to-treat principles. Of 134 postpartum individuals who underwent a cesarean delivery (mean [SD] age, 30.5 [4.6] years; mean [SD] gestational age at delivery, 38 weeks 6 days [8 days]), 67 were randomly assigned to the functional device group and 67 to the sham device group. Most were multiparous, had prepregnancy body mass index (calculated as weight in kilograms divided by height in meters squared) higher than 30, were privately insured, and received spinal anesthesia. One participant in the sham device group withdrew consent prior to treatment. Individuals assigned to the functional device used significantly less opioid medication prior to discharge (median [IQR], 19.75 [0-52.50] MME) than patients in the sham device group (median [IQR], 37.50 [7.50-67.50] MME; P = .046) and reported similar rates of moderate to severe pain (85% vs 91%; relative risk [RR], 0.77 [95% CI, 0.55-1.29]; P = .43) and mean pain scores (3.59 [95% CI, 3.21-3.98] vs 4.46 [95% CI, 4.01-4.92]; P = .004). Participants in the functional device group were prescribed fewer MME at discharge (median [IQR], 82.50 [0-90.00] MME vs 90.00 [75.00-90.00] MME; P < .001). They were also more likely to be discharged without an opioid prescription (25% vs 10%; RR, 1.58 [95% CI, 1.08-2.13]; P = .03) compared with the sham device group. No treatment-related adverse events occurred in either group. In this randomized clinical trial of postoperative patients following cesarean delivery, use of a high-frequency electrical stimulation device as part of a multimodal analgesia protocol decreased opioid use in the immediate postoperative period and opioids prescribed at discharge. These findings suggest that the use of this device may be a helpful adjunct to decrease opioid use without compromising pain control after cesarean delivery.