Peripheral Nerve Stimulation Research Articles

Cost Savings in Chronic Pain Patients Initiating Peripheral Nerve Stimulation (PNS) with a 60-Day PNS Treatment.

This study evaluates the financial impact on healthcare payers when chronic pain patients initiate peripheral nerve stimulation (PNS) with a 60-day percutaneous PNS (60-Day PNS) treatment versus a conventional brief PNS trial (PNS-BT) with possible follow-on of a permanently implanted PNS system (PNS-PI). Centers for Medicare & Medicaid Services (CMS) fee-for-service (FFS) data were analyzed to identify patients with at least 12months of follow-up (median 26.4months) who initiated PNS treatment with: (1) 60-Day PNS or (2) PNS-BT. An economic decision tree model assessed the cost to payers in each cohort. Clinical response to 60-Day PNS was estimated by retrospectively reviewing anonymized outcomes from a national real-world database, focusing on patients≥65years of age who were implanted with a 60-day percutaneous PNS system. For the economic model, a Monte Carlo simulation with 10,000 iterations was used to generate 95% confidence intervals, considering variability in treatment outcome probability and costs. Based on CMS data, among 60-Day PNS patients, 18% (229/1265) proceeded to a permanently implanted PNS system with a 4% explant rate (10/229). Among PNS-BT patients, 41% (1140/2811) received a permanent implant with a 7% rate of explant (77/1140). Estimated PNS-related weighted average costs for the 60-Day PNS cohort [US$17,344; 95% confidence interval (CI): $16,168-$18,527] were lower than the PNS-BT cohort ($24,392; 95% CI $22,865-$25,941) when considering the percent of patients who advanced to a permanently implanted PNS system. The total cost per successful outcome also favored 60-Day PNS ($25,228 per success for the 60-Day PNS cohort vs. $64,502 per success for the PNS-BT cohort) as a first-line approach in PNS treatment. The findings suggest that, when PNS for chronic pain is warranted, initiating PNS with a 60-day treatment is more cost-effective than utilizing a brief conventional trial.

Long-Term Effects of Spinal Cord Stimulation on Pain in Postherpetic Neuralgia

Introduction: Postherpetic neuralgia (PHN) is a pain syndrome that develops within few months after the acute herpetic outbreak. The pain may be accompanied by specific cutaneous signs in the distribution of affected dermatomes and feel unbearable reaching up to 9–10/10 on visual analog scale (VAS). Despite the introduction of new medications, drug resistance develops in at least 50% of cases. Neuromodulation techniques such as spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS) are considered as ones of the last resorts for PHN treatment, especially in pharmacoresistant patients. Recently, several studies with limited number of cases have shown high efficiency of neuromodulation (regression of pain syndrome in more than 82% of cases) after SCS in PHN patients, but these findings require further confirmation and have not been supported by large RCTs. Methods: Initially, 32 patients diagnosed with chronic drug-resistant PHN underwent a trial of SCS. Based on the trial results, a decision was made whether to implant a permanent SCS system. The condition of all patients implanted with SCS system was assessed using the VAS, SF-36, Patient Global Impression of Change (PGIC), and Medicine Quantification Scale, version III (MQS) questionnaires before the surgery and in the long-term follow-up. We also conducted systematic follow-up of patients who did not pass the test stimulation stage, using them as a control group to track the levels of pain. The hypothesis of normal distribution for quantitative values was tested using Shapiro-Wilk tests. Results: During the trial period, tonic spinal stimulation was effective in 16 out of 32 (50%) patients with drug-resistant PHN. Among 14 patients with implanted stimulators, a significant pain reduction (more than 50% from the baseline) was observed in 10 patients (71.4%). The pain level in patients with a tonic SCS was statistically lower than in patients receiving conservative therapy. For the entire group of patients with implanted SCS, a significant improvement was also observed in results of SF-36, PGIC, and MQS. Conclusion: Our clinical series demonstrates that tonic SCS was effective in 50% of patients with refractory PHN undergoing SCS trial. Significant improvement in pain control obtained during the long-term follow-up in patients treated with tonic SCS improves the quality of life and reduces the need for analgesic medications.

Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial

BackgroundThere is paucity of data from randomized controlled trials supporting the use of peripheral nerve stimulation, a well-established therapy for the treatment of chronic pain. This study was undertaken, in...

Different regulative effects of high- and low-frequency external trigeminal nerve stimulation (eTNS) on sleep activity: Preliminary study

Study objectiveWith the growing prominence of peripheral nerve stimulation technology, the clinical applications and potential neurophysiological mechanisms of external trigeminal nerve stimulation (eTNS) have garnered increasing attention. Despite its status as the sole neuromodulation method commonly employed in sleep, no studies have explored the effects of eTNS at varying frequencies on sleep activities. This study aims to investigate the regulatory effects of high-frequency and low-frequency eTNS on sleep activities using polysomnography. MethodsIn this within-subjects experiment, 20 participants underwent a night of adaptation sleep, followed by 8-h sessions of sham, 120Hz-, and 2Hz-eTNS interventions in a randomized order in the sleep laboratory, with polysomnographic signals collected throughout. ResultsThe results indicated that 120Hz-eTNS significantly improved sleep efficiency, increased N2 sleep proportion, and reduced sleep latency, without significantly affecting sleep stage transition probabilities, sleep duration, or sleep-specific wave activities. Conversely, while 2Hz-eTNS did not impact sleep efficiency or latency, it increased the proportion of N3 sleep, stabilizes N3 sleep, and enhanced the survival probability of N3 and REM sleep duration. Additionally, it increases the density of slow oscillations (SOs), improved the coupling ratio of SO-spindles, and enhanced coupling timing accuracy. ConclusionsThese findings suggest that eTNS during sleep can indeed modulate sleep activities, with different frequencies exerting distinct regulatory effects. This may hold significant value for advancing the clinical application and efficacy of eTNS.

Paired associative stimulation improves motor function in the upper extremity in chronic incomplete spinal cord injury: a corroborative study.

To corroborate findings suggesting that spinally targeted paired associative stimulation improves upper extremity motor function in chronic incomplete spinal cord injury. Prospective interventional study. Five adults with chronic tetraplegia. Participants received paired associative stimulation, combining peripheral nerve stimulation and navigated transcranial magnetic stimulation towards 1 arm (16 1-h sessions during 4 consecutive weeks, targeting the 3 large nerves). Manual muscle testing (MMT) was performed in 23 muscles in each arm, at 3 time points (pre-stimulation, t0; the week following the stimulation period, t1; and 4-5 weeks post-stimulation, t2). Additionally, grip strength and changes in the Canadian Occupational Performance Measure were assessed. The mean improvement in manual muscle testing scores in the targeted extremity was +0.49 at t1 (p = 0.078) and +0.55 at t2 (p = 0.062). Grip strength in the stimulated extremity increased by 3.2 kg at t1 and 3.4 kg at t2, and in the non-targeted extremity by 2.2 and 3.6 kg, respectively. Performance and satisfaction increased by 2.1/2.4 points at t1, and by 2.0/1.9 points at t2. Paired associative stimulation improved motor function: at the group level, MMT of the stimulated hand (p = 0.06) and non-stimulated hand (p = 0.04). Most participants achieved clinically relevant improvement. Thus, the results corroborate prior studies. The method may complement conventional rehabilitation for improving upper extremity function in incomplete tetraplegia.

Cognitive effect of passively induced kinesthetic perception associated with virtual body augmentation modulates spinal reflex.

The virtual movement of an augmented body, perceived as part of oneself, forms the basis of kinesthetic perception induced by visual stimulation (KINVIS). KINVIS is a visually induced virtual kinesthetic perception that clinically suppresses spasticity. The present study hypothesized that central neural network activity during KINVIS affects subcortical neural circuits. The present study aimed to elucidate whether reciprocal and presynaptic inhibition occurs during KINVIS. Seventeen healthy participants were recruited (mean age: 27.9 ± 3.6 years), and their soleus Hoffmann-reflexes (H-reflexs) were recorded by peripheral nerve stimulation while perceiving the dorsiflexion kinesthetic illusion in the right-side foot (seated in a comfortable chair). Two control conditions were set to observe the same foot video without the kinesthetic illusion while focusing on the static foot image. Unconditioned H-reflex and two types of conditioned H-reflexes were measured: Ia (reciprocal inhibition) and D1 (presynaptic inhibition). Reciprocal Ia and D1 inhibition of the soleus muscle was significantly enhanced during the kinesthetic illusion compared to the condition without kinesthetic illusion (a post-hoc analysis using the Bonferroni test: Ia inhibition, p = 0.002; D1 inhibition, p = 0.049). This study indicates that kinesthetic illusion elicits an inhibitory effect on the monosynaptic reflex loop of Ia afferents, potentially inhibiting the hyperexcitability of the stretch reflex. These findings demonstrate that brain activity associated with visually induced kinesthetic illusions acts on spinal inhibition circuits. These insights may be valuable in clinical rehabilitation practice, specifically for the treatment of spasticity.

Shaking Up Essential Tremor: Peripheral Devices and Mechanical Strategies to Reduce Tremor.

This review discusses non-pharmacological, non-surgical interventions for action tremor, including essential tremor (ET). We review transcutaneous peripheral nerve stimulation (PNS), a variety of orthotic/mechanical devices, cooling and vibration strategies, and adaptive utensils, most of which are currently available. The PNS section discusses open loop (CALA-Trio) and closed loop systems (Felix™, NeuroAI™ and Motimove® systems). Orthotic devices which physically dampen tremor include Tremulo™, GyroGlove™, WOTAS exoskeleton, Magnetorheological Fluid-Based Exoskeleton System, Steadi-One® and Steadi-Two®, and Readi-Steady®. Adaptive devices include weighted spoons, deep cavity spoons, counter-balance utensils, and electrical actuator devices. Despite availability, most of these devices have limited to no published clinical trial data.

Soft-Actuated Cuff Electrodes with Minimal Contact for Bidirectional Peripheral Interfaces.

Neural interfaces with embedded electrical functions, such as cuff electrodes, are essential for monitoring and stimulating peripheral nerves. Still, several challenges remain with cuff electrodes because sutured devices can damage the nerve by high pressure and the secured contact of electrodes with the nerve is hard to accomplish, which however is essential in maintaining electrical performance. Here, a sutureless soft-actuated cuff electrodes (SACE) that can envelop the nerve conveniently by creating a bent shape controlled upon fluid injection, is introduced. Moreover, fluid injection protrudes part of the device where electrodes are formed, thereby achieving minimized, soft but secure contact between the electrodes and the nerve. In vivo results demonstrate the successful recording and stimulation of peripheral nerves over time up to 6 weeks. While securing contact with the nerve, the implanted electrodes can preserve the nerve intact with no reduction in blood flow, thereby indicating only minimal compressive force applied to the nerve. The SACE is expected to be a promising tool for recording and stimulation of peripheral nerves toward bidirectional neuroprostheses.

The Role of Peripheral Nerve Stimulation in Perioperative Analgesia

The Role of Peripheral Nerve Stimulation in Perioperative Analgesia

Meralgia paresthetica treated with temporary peripheral nerve stimulation

The Article Abstract is not available.

Ultrasound guided transcutaneous phrenic nerve stimulation in critically ill patients: a new method to evaluate diaphragmatic function.

Diaphragm dysfunction is common in intensive care unit and associated with weaning failure and mortality. Diagnosis gold standard is the transdiaphragmatic or tracheal pressure induced by magnetic phrenic nerve stimulation. However, the equipment is not commonly available and requires specific technical skills. We aimed to evaluate ultrasound guided transcutaneous phrenic nerve stimulation for daily bedside assessment of diaphragm function by targeted electrical phrenic nerve stimulation. In this randomized cross-over study we compared a new method of ultrasound guided transcutaneous electrical phrenic nerve stimulation (SONOTEPS method) using a peripheral nerve stimulator, with the magnetic phrenic nerve stimulation. Intensive care unit adult patients under mechanical ventilation with a Richmond-Agitation-Sedation-Scale score of -4 or -5 were included. Each patient received the two methods of stimulation, in a randomized order. The primary outcome was the tracheal pressure (Ptrach) induced by stimulation. We analyzed 232 measures of Ptrach from 116 patients of whom 77 presented a diaphragm dysfunction (Ptrach < 11 cmH2O) and 50 a severe diaphragm dysfunction (Ptrach < 8 cmH2O). The Passing-Bablok regression showed no significant differences (intercept A of -0.03 [CI95:-0.83-0.52] and slope B of 0.98 [CI95:0.90-1.05]) between SONOTEPS method and magnetic stimulation which were positively correlated (R²=0.639). The mean bias was -1.08 (CI95 5.02, -7.18) cmH2O. The receiver operating curves showed an excellent performance for the diagnosis of diaphragm dysfunction and severe diaphragm dysfunction with respectively an area under curve of 0.90 (CI95 0.83-0.97) and 0.88 (CI95 0.82-0.95). This performance was not significantly affected by the body mass index or the presence of a neck catheter. The SONOTEPS method is a simple and accurate tool for bedside assessment of diaphragm function with ultrasound guided transcutaneous phrenic nerve stimulation in sedated patients with no or minimal spontaneous respiratory activity.

Feasibility of a simultaneous ultrasound (US) and peripheral nerve stimulation (PNS) guided interscalene brachial plexus injection in calves

Feasibility of a simultaneous ultrasound (US) and peripheral nerve stimulation (PNS) guided interscalene brachial plexus injection in calves

Measurement of peripheral nerve magnetostimulation thresholds of a head solenoid coil between 200 Hz and 88.1 kHz.

Magnetic fields switching at kilohertz frequencies induce electric fields in the body that can cause peripheral nerve stimulation (PNS). Magnetically induced PNS, i.e. magnetostimulation, has been extensively studied below 10 kHz. It is widely characterized using a hyperbolic strength-duration curve (SDC), where the PNS thresholds monotonically decrease with frequency. The very few studies performed at higher frequencies found significant deviations from the hyperbolic SDC above ~ 25 kHz, however, those measurements are sparse and show large variability. We fill the gap in the data by measuring PNS in the head of 8 volunteers using a solenoidal coil at 16 frequencies between 200 Hz and 88.1 kHz. Contrary to the hyperbolic SDC, PNS thresholds did not decrease monotonically with frequency, but reached a minimum ~ 25 kHz. The thresholds then increased by 39% from 25 kHz to 88.1 kHz on average across subjects. Our measurements can be used for guidance and validation of neurodynamic models and to inform PNS limits of magnetic resonance imaging (MRI) gradient coils and magnetic particle imaging (MPI) systems. The observed deviation of the experimentally measured thresholds from the hyperbolic SDC calls for further study of the underlying biological mechanisms of magnetostimulation beyond 25 kHz.

Magnetoelectrics for Implantable Bioelectronics: Progress to Date.

ConspectusThe coupling of magnetic and electric properties manifested in magnetoelectric (ME) materials has unlocked numerous possibilities for advancing technologies like energy harvesting, memory devices, and medical technologies. Due to this unique coupling, the magnetic properties of these materials can be tuned by an electric field; conversely, their electric polarization can be manipulated through a magnetic field.Over the past seven years, our lab work has focused on leveraging these materials to engineer implantable bioelectronics for various neuromodulation applications. One of the main challenges for bioelectronics is to design miniaturized solutions that can be delivered with minimally invasive procedures and yet can receive sufficient power to directly stimulate tissue or power electronics to perform functions like communication and sensing.Magnetoelectric coupling in ME materials is strongest when the driving field matches a mechanical resonant mode. However, miniaturized ME transducers typically have resonance frequencies >100 kHz, which is too high for direct neuromodulation as neurons only respond to low frequencies (typically <1 kHz). We discuss two approaches that have been proposed to overcome this frequency mismatch: operating off-resonance and rectification. The off-resonance approach is most common for magnetoelectric nanoparticles (MENPs) that typically have resonance frequencies in the gigahertz range. In vivo experiments on rat models have shown that MENPs could induce changes in neural activity upon excitation with <200 Hz magnetic fields. However, the neural response has latencies of several seconds due to the weak coupling in the off-resonance regime.To stimulate neural responses with millisecond precision, we developed methods to rectify the ME response so that we could drive the materials at their resonant frequency but still produce the slowly varying voltages needed for direct neural stimulation. The first version of the stimulator combined a ME transducer and analog electronics for rectification. To create even smaller solutions, we introduced the first magnetoelectric metamaterial (MNM) that exhibits self-rectification. Both designs have effectively induced neural modulation in rat models with less than 5 ms latency.Based on our experience with in vivo testing of the rectified ME stimulators, we found it challenging to deliver the precisely controlled therapy required for clinical applications, given the ME transducer's sensitivity to the external transmitter alignment. To overcome this challenge, we developed the ME-BIT (MagnetoElectric BioImplanT), a digitally programmable stimulator that receives wireless power and data through the ME link.We further expanded the utility of this technology to neuromodulation applications that require high stimulation thresholds by introducing the DOT (Digitally programmable Overbrain Therapeutic). The DOT has voltage compliance up to 14.5 V. We have demonstrated the efficacy of these designs through various in vivo studies for applications like peripheral nerve stimulation and epidural cortical stimulation.To further improve these systems to be adaptive and enable a network of coordinated devices, we developed a bidirectional communication system to transmit data to and from the implant. To enable even greater miniaturization, we developed a way to use the same ME transducer for wireless power and data communication by developing the first ME backscatter communication protocol.

Neuromodulation for Neuropathic Pain Syndromes

ABSTRACT OBJECTIVE This article reviews the principles, applications, and emerging trends of neuromodulation as a therapeutic approach for managing painful neuropathic diseases. By parsing evidence for possible mechanisms of action and clinical trial outcomes for various diseases, this article focuses on five common therapy modalities: cutaneous, peripheral nerve, spinal cord, and brain stimulation, and intrathecal drug delivery. LATEST DEVELOPMENTS Recent advances in both invasive and noninvasive neuromodulation for pain have introduced personalized and closed-loop techniques, integrating real-time feedback mechanisms and combining therapies to improve physical and psychosocial function. Novel stimulation waveforms may influence distinct neural tissues to rectify pathologic pain signaling. ESSENTIAL POINTS With appropriate patient selection, peripheral nerve stimulation or epidural stimulation of the spinal cord can provide enduring relief for a variety of chronic pain syndromes. Newer technology using high frequencies, unique waveforms, or closed-loop stimulation may have selective advantages, but our current understanding of therapy mechanisms is very poor. For certain diagnoses and patients who meet clinical criteria, neuromodulation can provide profound, long-lasting relief that significantly improves quality of life. While many therapies are supported by data from large clinical trials, there is a risk of bias as most clinical studies were funded by device manufacturers or insurance companies, which increases the importance of real-world data analysis. Emerging methods like invasive or noninvasive brain stimulation may help us dissect basic mechanisms of pain processing and hold promise for personalized therapies for refractory pain syndromes. Finally, intrathecal delivery of drugs directly to segments of the spinal cord can also modify pain signaling to provide therapy for severe pain syndromes.

ID: 336211 Intercostal Neuralgia Successfully Managed with Peripheral Nerve Stimulation: A Case Report

ID: 336211 Intercostal Neuralgia Successfully Managed with Peripheral Nerve Stimulation: A Case Report

Simultaneous modulation of pulse charge and burst period elicits two differentiable referred sensations

Objective.To investigate the feasibility of delivering multidimensional feedback using a single channel of peripheral nerve stimulation by complementing intensity percepts with flutter frequency percepts controlled by burst period modulation.Approach.Two dimensions of a distally referred sensation were provided simultaneously: intensity was conveyed by the modulation of the pulse charge rate inside short discrete periods of stimulation referred to as bursts and frequency was conveyed by the modulation of the period between bursts. For this approach to be feasible, intensity percepts must be perceived independently of frequency percepts. Two experiments investigated these interactions. A series of two alternative forced choice tasks (2AFC) were used to investigate burst period modulation's role in intensity discernibility. Magnitude estimation tasks were used to determine any interactions in the gradation between the frequency and intensity percepts.Main results.The 2AFC revealed that burst periods can be individually differentiated as a gradable frequency percept in peripheral nerve stimulation. Participants could correctly rate a perceptual scale of intensity and frequency regardless of the value of the second, but the dependence of frequency differentiability on charge rate indicates that frequency was harder to detect with weaker intensity percepts. The same was not observed in intensity differentiability as the length of burst periods did not significantly alter intensity differentiation. These results suggest multidimensional encoding is a promising approach for increasing information throughput in sensory feedback systems if intensity ranges are selected properly.Significance.This study offers valuable insights into haptic feedback through the peripheral nervous system and demonstrates an encoding approach for neural stimulation that may offer enhanced information transfer in virtual reality applications and sensory-enabled prosthetic systems. This multidimensional encoding strategy for sensory feedback may open new avenues for enriched control capabilities.

ID: 317303 Atypical headache and facial pain treated with a unilateral dual lead peripheral occipital nerve stimulator

ID: 317303 Atypical headache and facial pain treated with a unilateral dual lead peripheral occipital nerve stimulator

ID: 343080 A Report on Interim Long-term Pain Outcomes from the COMFORT Peripheral Nerve Stimulation RCT

ID: 343080 A Report on Interim Long-term Pain Outcomes from the COMFORT Peripheral Nerve Stimulation RCT

ID: 323169 Clinical Outcomes of Peripheral Nerve Stimulation: A Multi-Center Retrospective Analysis

ID: 323169 Clinical Outcomes of Peripheral Nerve Stimulation: A Multi-Center Retrospective Analysis