Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial.

Bimodal neuromodulation is emerging as a nonsurgical treatment for tinnitus. Bimodal treatment combining sound therapy with electrical tongue stimulation using the Lenire device is evaluated in a controlled pivotal trial (TENT-A3, NCT05227365) consisting of 6-weeks of sound-only stimulation (Stage 1) followed by 6-weeks of bimodal treatment (Stage 2) with 112 participants serving as their own control. The primary endpoint compares the responder rate observed in Stage 2 versus Stage 1, where a responder exceeds 7 points in the Tinnitus Handicap Inventory. In participants with moderate or more severe tinnitus, there is a clinically superior performance of bimodal treatment (58.6%; 95% CI: 43.5%, 73.6%; p = 0.022) compared to sound therapy alone (43.2%; 95% CI: 29.7%, 57.8%), which is not observed in the full cohort across all severity groups. Consistent results are observed for the secondary endpoint based on the Tinnitus Functional Index (bimodal treatment: 45.5%; 95% CI: 31.7%, 59.9%; sound-only stimulation: 29.6%; 95% CI: 18.2%, 44.2%; p = 0.010), where a responder exceeds 13 points. There are no device related serious adverse events. These positive outcomes led to FDA De Novo approval of the Lenire device for tinnitus treatment.

An ingestible, battery-free, tissue-adhering robotic interface for non-invasive and chronic electrostimulation of the gut.

Ingestible electronics have the capacity to transform our ability to effectively diagnose and potentially treat a broad set of conditions. Current applications could be significantly enhanced by addressing poor electrode-tissue contact, lack of navigation, short dwell time, and limited battery life. Here we report the development of an ingestible, battery-free, and tissue-adhering robotic interface (IngRI) for non-invasive and chronic electrostimulation of the gut, which addresses challenges associated with contact, navigation, retention, and powering (C-N-R-P) faced by existing ingestibles. We show that near-field inductive coupling operating near 13.56 MHz was sufficient to power and modulate the IngRI to deliver therapeutically relevant electrostimulation, which can be further enhanced by a bio-inspired, hydrogel-enabled adhesive interface. In swine models, we demonstrated the electrical interaction of IngRI with the gastric mucosa by recording conductive signaling from the subcutaneous space. We further observed changes in plasma ghrelin levels, the "hunger hormone," while IngRI was activated in vivo, demonstrating its clinical potential in regulating appetite and treating other endocrine conditions. The results of this study suggest that concepts inspired by soft and wireless skin-interfacing electronic devices can be applied to ingestible electronics with potential clinical applications for evaluating and treating gastrointestinal conditions.

In situ assembly of an injectable cardiac stimulator.

Without intervention, cardiac arrhythmias pose a risk of fatality. However, timely intervention can be challenging in environments where transporting a large, heavy defibrillator is impractical, or emergency surgery to implant cardiac stimulation devices is not feasible. Here, we introduce an injectable cardiac stimulator, a syringe loaded with a nanoparticle solution comprising a conductive polymer and a monomer that, upon injection, forms a conductive structure around the heart for cardiac stimulation. Following treatment, the electrode is cleared from the body, eliminating the need for surgical extraction. The mixture adheres to the beating heart in vivo without disrupting its normal rhythm. The electrofunctionalized injectable cardiac stimulator demonstrates a tissue-compatible Young's modulus of 21 kPa and a high conductivity of 55 S/cm. The injected electrode facilitates electrocardiogram measurements, regulates heartbeat in vivo, and rectifies arrhythmia. Conductive functionality is maintained for five consecutive days, and no toxicity is observed at the organism, organ, or cellular levels.

The ReInvigorate Study-phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial.

BACKGROUND: In the United States in 2017, there were an estimated 903,745 hospitalizations involving mechanical ventilation (MV). Complications from ventilation can result in longer hospital stays, increased risk of disability, and increased healthcare costs. It has been hypothesized that electrically pacing the diaphragm by phrenic nerve stimulation during mechanical ventilation may minimize or reverse diaphragm dysfunction, resulting in faster weaning. METHODS: The ReInvigorate Trial is a prospective, multicenter, randomized, controlled clinical trial evaluating the safety and efficacy of Stimdia's pdSTIM System for facilitating weaning from MV. The pdSTIM system employs percutaneously placed multipolar electrodes to stimulate the cervical phrenic nerves and activate contraction of the diaphragm bilaterally. Patients who were on mechanical ventilation for at least 96 h and who failed at least one weaning attempt were considered for enrollment in the study. The primary efficacy endpoint was the time to successful liberation from mechanical ventilation (treatment vs. control). Secondary endpoints will include the rapid shallow breathing index and other physiological and system characteristics. Safety will be summarized for both primary and additional analyses. All endpoints will be evaluated at 30 days or at the time of removal of mechanical ventilation, whichever is first. DISCUSSION: This pivotal study is being conducted under an investigational device exception with the U.S. Food and Drug Administration. The technology being studied could provide a first-of-kind therapy for difficult-to-wean patients on mechanical ventilation in an intensive care unit setting. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05998018 , registered August 2023.

The MuscleSCS Technique (4-8Hz BurstDRTM Octrode™): A Randomized Clinical Study of MuscleSCS Stimulation in the Treatment of Chronic Back Pain.

BACKGROUND: MuscleSCS is a new technique that combines spinal cord stimulation (SCS) with muscle stimulation to relieve pain. OBJECTIVES: In this clinical study, we wanted to use rod electrodes to investigate the MuscleSCS method's effectiveness in the treatment of chronic lower back pain. One of our hypotheses was that the combined use of MuscleSCS and BurstDRTM would further improve the treatment. STUDY DESIGN: A prospective, single-center, single-blinded, randomized crossover study. SETTING: A university medical center. METHODS: Patients with chronic lower back pain had previously (one to 10 years ago) received an SCS system (Octrode™). In this study, they were randomly treated for 2 weeks each with BurstDRTM stimulation alone, MuscleSCS stimulation alone, or a combination of BurstDRTM stimulation and MuscleSCS stimulation. Thereafter, the patients were treated for another 6 weeks with one of the 3 methods (crossover possible). Pain ratings on the visual analog scale (VAS) were recorded and compared. A Pain Disability Index (PDI) questionnaire was used at the baseline and at 3 months. RESULTS: We included 24 patients in this study (11 women, mean age 62.3 yrs.) The values of the second week of the stimulation were the only ones used for the calculations. The first week of the stimulation was used as a wash-out period.The combined application of BurstDRTM and MuscleSCS stimulation was associated with the best results (P = 0.032). PDI scores did not improve during this treatment. No serious adverse events occurred during this study. Seventy-one and a half percent of the patients experienced an improvement in their pain as a result of the additional MuscleSCS stimulation. LIMITATIONS: In this study, only one fixed contact setting (3 & 4) was used to ensure uniform conditions for all patients and the ability to compare the different treatment modes. CONCLUSION: This study showed that the combined application of SCS (BurstDRTM) and additional MuscleSCS stimulation using a rod electrode could significantly improve outcomes for patients suffering from chronic back pain.

Innovations in Neurostimulation.

While The Big medical device makers may have a deep-pockets advantage in the neurostimulation space, many smaller players are innovating their way to advances that offer tantalizing hope for changing patients' lives.

Real-time closed-loop brainstem stimulation modality for enhancing temporal blood pressure reduction.

BACKGROUND: Traditional pharmacological interventions are well tolerated in the management of elevated blood pressure (BP) for individuals with resistant hypertension. Although neuromodulation has been investigated as an alternative solution, its open-loop (OL) modality cannot follow the patient's physiological state. In fact, neuromodulation for controlling highly fluctuating BP necessitates a closed-loop (CL) stimulation modality based on biomarkers to monitor the patient's continuously varying physiological state. OBJECTIVE: By leveraging its intuitive linkage with BP responses in ongoing efforts aimed at developing a CL system to enhance temporal BP reduction effect, this study proposes a CL neuromodulation modality that controls nucleus tractus solitarius (NTS) activity to effectively reduce BP, thus reflecting continuously varying physiological states. METHOD: While performing neurostimulation targeting the NTS in the rat model, the arterial BP response and neural activity of the NTS were simultaneously measured. To evaluate the temporal BP response effect of CL neurostimulation, OL (constant parameter; 20 Hz, 200 µA) and CL (Initial parameter; 11 Hz, 112 µA) stimulation protocols were performed with stimulation 180 s and rest 600 s, respectively, and examined NTS activity and BP response to the protocols. RESULTS: In-vivo experiments for OL versus CL protocol for direct NTS stimulation in rats demonstrated an enhancement in temporal BP reduction via the CL modulation of NTS activity. CONCLUSION: This study proposes a CL stimulation modality that enhances the effectiveness of BP control using a feedback control algorithm based on neural signals, thereby suggesting a new approach to antihypertensive neuromodulation.

Atypical refractory occipital neuralgia treated with a unilateral dual-lead occipital nerve stimulator: a case report.

Aim: To describe the successful treatment of atypical occipital neuralgia (ON) using a unilateral dual-lead occipital nerve stimulator.Setting: Outpatient clinic/operating room.Patient: A 53-year-old male with atypical ON.Case description: Patient was previously diagnosed with treatment-refractory left-sided trigeminal neuralgia with atypical occipital distribution. On presentation, his symptoms were consistent with ON with distribution to the left fronto-orbital area. He received a left-sided nerve stimulator implant targeting both the greater and lesser occipital nerves.Results: Patient reported pain relief from a numerical rating scale 10/10 to 3-4/10.Conclusion: ON with referred ipsilateral trigeminal distribution should be considered when patients present with simultaneous facial and occipital pain. Further, a dual-lead unilateral stimulator approach may be a viable treatment.

Atypical, persistent inflammation to the left occipital nerve treated with a neuromodulator: a case reportAim: To describe the successful treatment of atypical headache using a one-sided nerve stimulator.Setting: Outpatient clinic/operating room.Patient: A 53-year-old male with atypical headache.Case description: Patient was previously diagnosed with left-sided chronic facial pain with pain to the back of the head. He previously failed to improve with medication and underwent Botox injections and several surgical operations targeting the nerves responsible for his pain symptoms with no improvement. He recently underwent a nerve-stimulating device trial, designed to alter the activity levels of the targeted nerve, that targeted a nerve in the back of his head. This significantly improved his pain and he ultimately presented for an official stimulator implant. Upon presentation, his symptoms were consistent with left-sided headache to the back of the head with distribution to the left eye area.Results: Patient reported significant pain relief from 10/10 to a 3-4/10, with a 10 representing the worst pain the patient has ever felt.Conclusion: Left-sided headache on the back of the head that can distribute to the left eye area should be a consistent thought for pain/headache practitioners. Further, this stimulator placement approach may be a viable treatment.

Effects of Rehabilitative Exercise and Neuromuscular Electrical Stimulation on Muscle Morphology and Dynamic Balance in Individuals with Chronic Ankle Instability.

Background and Objectives: Muscle atrophy caused by chronic ankle instability (CAI) can incur muscle weakness, altered movement patterns, and increased risk of injury. Previous studies have investigated the effects of rehabilitative exercises and neuromuscular electrical stimulation (NMES) on characteristics in CAI individuals, but few studies have examined their effects on foot and ankle muscle morphology. This study aimed to determine the effects of rehabilitative exercises and NMES on muscle morphology and dynamic balance in individuals with CAI. Materials and Methods: Participants with CAI (n = 47) were randomly divided into control (CG), rehabilitative exercise (REG), NMES (NG), and rehabilitative exercise and NMES combined (RNG) groups. The six-week intervention program consisting of rehabilitative exercises and NMES was applied to groups excluding CG. Muscle morphology and dynamic balance were evaluated using a portable wireless diagnostic ultrasound device and dynamic balance tests. For statistical analysis, an effect size with 95% confidence interval was calculated to assess mean differences according to intervention. Results: After six weeks, significant increases in morphology and dynamic balance were observed for all muscles except flexor hallucis longus (p > 0.05) in the intervention groups except for CG. However, no significant changes were observed in the CG (p > 0.05). Conclusions: These findings suggest that intervention programs may help prevent muscle atrophy and improve balance in CAI individuals.

Endovascular stimulation of the pudendal nerve using a stent-mounted electrode array.

Objective. Previous preclinical and clinical studies have demonstrated that pudendal nerve is a promising target for restoring bladder control. The spatial proximity between the pudendal nerve and its accompanying blood vessels in the pudendal canal provides an opportunity for endovascular neurostimulation, which is a less invasive approach compared to conventional chronically implanted electrodes. In this study, we investigated the feasibility of excitatory stimulation and kilohertz-frequency block of the compound pudendal nerve in sheep using a stent-mounted electrode array.Approach. In a set of acute animal experiments, a commercially available hexapolar electrode catheter was introduced in the unilateral internal pudendal artery to deliver bipolar electrical stimulation of the adjacent compound pudendal nerve. The catheter electrode was replaced with a custom-made stent-mounted electrode array and the stimulation sessions were repeated. Global electromyogram activity of the pelvic floor and related sphincter muscles was recorded with a monopolar electrode placed within the urethra concurrently.Main results. We demonstrated the feasibility of endovascular stimulation of the pudendal nerve with both electrode types. The threshold current of endovascular stimulation was influenced by electrode-nerve distance and electrode orientation. Increasing the axial inter-electrode distance significantly decreased threshold current. Endovascular kilohertz-frequency nerve block was possible with the electrode catheter.Significance. The present study demonstrated that endovascular stimulation of the pudendal nerve with the stent-mounted electrode array may be a promising less invasive alternative to conventional implantable electrodes, which has important clinical implications in the treatment of urinary incontinence. Endovascular blocking of pudendal nerve may provide an alternative solution to the bladder-sphincter dyssynergia problem in bladder management for people with spinal cord injury.

Pharmacologic, Surgical, and Device-Based Cardiac Neuromodulation.

The cardiac autonomic nervous system plays a key role in maintaining normal cardiac physiology, and once disrupted, it worsens the cardiac disease states. Neuromodulation therapies have been emerging as new treatment options, and various techniques have been introduced to mitigate autonomic nervous imbalances to help cardiac patients with their disease conditions and symptoms. In this review article, we discuss various neuromodulation techniques used in clinical settings to treat cardiac diseases.

Comparison of Cambridge vision stimulator (CAM) therapy with passive occlusion therapy in the management of unilateral amblyopia; a randomized clinical trial.

INTRODUCTION: There are limited studies on the effectiveness of Cambridge vision stimulator (CAM) therapy as a management strategy in amblyopic patients. In addition, all these studies have a low sample size. The main purpose of this study was to compare the effect of CAM therapy with passive occlusion therapy in the management of unilateral amblyopia. METHODS: In this randomized clinical trial study, 110 cooperative amblyopic children, who had not been managed previously, were randomly divided into two groups of CAM therapy (n = 55) and passive occlusion therapy (n = 55). In the CAM procedure, five discs with different spatial frequencies (SF) (2, 6, 15, 20, 30 cycles/degree) were presented to the patient (30 minutes a day, twice a week). Plates with SF equal to the two lines better than the measured corrected distance visual acuity (CDVA) were chosen. During the training, the non-amblyopic eye was occluded. The standard occlusion therapy protocols were performed in the occlusion therapy group. The CDVA for all patients was measured at baseline and then at one, two, and three months after the treatment. RESULTS: The mean age of patients in CAM and occlusion therapy groups was 7.0 ± 2.1 and 6.9 ± 1.9 years, respectively (p = .721). There was no significant difference in the mean CDVA between CAM and occlusion therapy groups after one (0.30 ± 0.16 vs. 0.25 ± 0.14, p = .079), two (0.15 ± 0.10 vs. 0.15 ± 0.11, p = .732) and three months (0.05 ± 0.08 and 0.05 ± 0.06, p = .919) from baseline. However, the mean amount of CDVA increased significantly in each follow-up in both groups (all p < .001). Regarding the amblyopia type and severity, the mean improvement of CDVA from baseline in the anisometropic patients and in moderate amblyopia was significantly higher in the CAM group than the occlusion group after two and three months (p < .05). DISCUSSION: CAM and conventional occlusion therapies significantly improved CDVA in children with amblyopia, and the difference was not significant; therefore, they could be used as alternatives. CAM therapy requires cost and time for the amblyopic patient and parents. Thus, it can be considered as a second treatment option in amblyopic patients, especially anisometropic type and moderate amblyopia, with poor compliance to patching.

The muscle pump activator device: From evidence to lived experiences.

A chronic wound is one that fails to progress through a normal timely sequence of repair, or in which the repair process fails to restore anatomic and functional integrity after 3 months. The most common chronic wounds include venous, ischaemic and mixed leg ulcers, diabetic foot ulcers and pressure injuries. Chronic wounds place immense physical and psychosocial burden on patients and exact heavy costs for healthcare systems, with many patients continuing to live with chronic wounds even after all management options have been exhausted. The muscle pump activator (MPA) device can be used to bridge this therapeutic gap. By stimulating the common peroneal nerve to activate venous muscle pump of the leg and foot, the MPA device increases blood flow to the lower leg and foot to improve conditions for healing. Currently, evidence in the literature exist to show that the MPA device improves wound outcomes over standard compression therapy, decreases edema and increases wound healing rates. In this review, we also present a series of chronic wound patients treated with the MPA device in multicentre clinics to demonstrate the ability of the MPA device to improve wound outcomes, reduce pain and edema and improve patient quality of life.

MEFFNet: Forecasting Myoelectric Indices of Muscle Fatigue in Healthy and Post-Stroke During Voluntary and FES-Induced Dynamic Contractions.

Myoelectric indices forecasting is important for muscle fatigue monitoring in wearable technologies, adaptive control of assistive devices like exoskeletons and prostheses, functional electrical stimulation (FES)-based Neuroprostheses, and more. Non-stationary temporal development of these indices in dynamic contractions makes forecasting difficult. This study aims at incorporating transfer learning into a deep learning model, Myoelectric Fatigue Forecasting Network (MEFFNet), to forecast myoelectric indices of fatigue (both time and frequency domain) obtained during voluntary and FES-induced dynamic contractions in healthy and post-stroke subjects respectively. Different state-of-the-art deep learning models along with the novel MEFFNet architecture were tested on myoelectric indices of fatigue obtained during [Formula: see text] voluntary elbow flexion and extension with four different weights (1 kg, 2 kg, 3 kg, and 4 kg) in sixteen healthy subjects, and [Formula: see text] FES-induced elbow flexion in sixteen healthy and seventeen post-stroke subjects under three different stimulation patterns (customized rectangular, trapezoidal, and muscle synergy-based). A version of MEFFNet, named as pretrained MEFFNet, was trained on a dataset of sixty thousand synthetic time series to transfer its learning on real time series of myoelectric indices of fatigue. The pretrained MEFFNet could forecast up to 22.62 seconds, 60 timesteps, in future with a mean absolute percentage error of 15.99 ± 6.48% in voluntary and 11.93 ± 4.77% in FES-induced contractions, outperforming the MEFFNet and other models under consideration. The results suggest combining the proposed model with wearable technology, prosthetics, robotics, stimulation devices, etc. to improve performance. Transfer learning in time series forecasting has potential to improve wearable sensor predictions.

Bronchial Rheoplasty for Chronic Bronchitis: Results from a Canadian Feasibility Study with RheOx®.

Purpose: Chronic bronchitis (CB), a chronic obstructive pulmonary disease (COPD) phenotype defined by persistent mucus hypersecretion and cough, is associated with poor quality of life, exacerbations, and lung function impairment. Bronchial Rheoplasty (BR) delivers non-thermal pulsed electric fields to airway epithelium and submucosa. Preliminary studies demonstrated reduced airway goblet cell hyperplasia and symptom improvement in response to BR. This study aimed to further assess the safety and clinical feasibility of BR in the setting of CB. Patients and Methods: This 3-center, single-arm study evaluated the safety and feasibility of BR in Canadian patients. The major inclusion criteria were the sum of CAT first 2 questions (cough and mucus) ≥ 7 out of 10 and FEV1 ≥ 30% predicted. Right-sided airways were treated first; left, 1 month later. Serious adverse events (SAEs) were tabulated through 12 months. Outcomes were evaluated using the SGRQ and CAT. Results: Ten patients with CB were enrolled and followed for 12 months. The BR procedure was successful in all patients (mean age 69 ± 5.8 years, post-BD FEV1 77.1 ± 28.3, SGRQ 56.2 ± 8.8, CAT 25.4 ± 4.7). Only one SAE, a COPD exacerbation 13 days following the BR procedure, was considered device related. No additional SAEs occurred through 12 months, and 90% of the patients were CAT responders (≥ 2-point improvement) at 3 and 6 months. Similar results were observed in SGRQ. Conclusion: BR was safe and well-tolerated. Meaningful symptom improvement was observed through 12 months, suggesting BR may be a viable treatment option for patients with CB.

Revolutionizing motor dysfunction treatment: A novel closed-loop electrical stimulator guided by multiple motor tasks with predictive control.

Functional electrical stimulation (FES) has been demonstrated as a viable method for addressing motor dysfunction in individuals affected by stroke, spinal cord injury, and other etiologies. By eliciting muscle contractions to facilitate joint movements, FES plays a crucial role in fostering the restoration of motor function compromised nervous system. In response to the challenge of muscle fatigue associated with conventional FES protocols, a novel biofeedback electrical stimulator incorporating multi-motor tasks and predictive control algorithms has been developed to enable adaptive modulation of stimulation parameters. The study initially establishes a Hammerstein model for the stimulated muscle group, representing a time-varying relationship between the stimulation pulse width and the root mean square (RMS) of the surface electromyography (sEMG). An online parameter identification algorithm utilizing recursive least squares is employed to estimate the time-varying parameters of the Hammerstein model. Predictive control is then implemented through feedback corrections based on the comparison between predicted and actual outputs, guided by an optimization objective function. The integration of predictive control and roll optimization enables closed-loop control of muscle stimulation. The motor training tasks of elbow flexion and extension, wrist flexion and extension, and five-finger grasping were selected for experimental validation. The results indicate that the model parameters were accurately identified, with a RMS error of 3.83 % between actual and predicted values. Furthermore, the predictive control algorithm, based on the motor tasks, effectively adjusted the stimulus parameters to ensure that the stimulated muscle groups can achieve the desired sEMG characteristic trajectory. The biofeedback electrical stimulator that was developed has the potential to assist patients experiencing motor dysfunction in achieving the appropriate joint movements. This research provides a foundation for a novel intelligent electrical stimulation model.

Minimally-invasive implantable device enhances brain cancer suppression.

Current brain tumor treatments are limited by the skull and BBB, leading to poor prognosis and short survival for glioma patients. We introduce a novel minimally-invasive brain tumor suppression (MIBTS) device combining personalized intracranial electric field therapy with in-situ chemotherapeutic coating. The core of our MIBTS technique is a wireless-ultrasound-powered, chip-sized, lightweight device with all functional circuits encapsulated in a small but efficient "Swiss-roll" structure, guaranteeing enhanced energy conversion while requiring tiny implantation windows ( ~ 3 × 5 mm), which favors broad consumers acceptance and easy-to-use of the device. Compared with existing technologies, competitive advantages in terms of tumor suppressive efficacy and therapeutic resolution were noticed, with maximum ~80% higher suppression effect than first-line chemotherapy and 50-70% higher than the most advanced tumor treating field technology. In addition, patient-personalized therapy strategies could be tuned from the MIBTS without increasing size or adding circuits on the integrated chip, ensuring the optimal therapeutic effect and avoid tumor resistance. These groundbreaking achievements of MIBTS offer new hope for controlling tumor recurrence and extending patient survival.

The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.