Assessing the Effect of Cervical Transcutaneous Spinal Stimulation With an Upper Limb Robotic Exoskeleton and Surface Electromyography.

Transcutaneous spinal stimulation (TSS) is a promising rehabilitative intervention to restore motor function and coordination for individuals with spinal cord injury (SCI). The effects of TSS are most commonly assessed by evaluating muscle response to stimulation using surface electromyography (sEMG). Given the increasing use of robotic devices to deliver therapy and the emerging potential of hybrid rehabilitation interventions that combine neuromodulation with robotic devices, there is an opportunity to leverage the on-board sensors of the robots to measure kinematic and torque changes of joints in the presence of stimulation. This paper explores the potential for robotic assessment of the effects of TSS delivered to the cervical spinal cord. We used a four degree-of-freedom exoskeleton to measure the torque response of upper limb (UL) joints during stimulation, while simultaneously recording sEMG. We analyzed joint torque and electromyography data generated during TSS delivered over individual sites of the cervical spinal cord in neurologically intact participants. We show that site-specific effects of TSS are manifested not only by modulation of the amplitude of spinally evoked motor potentials in UL muscles, but also by changes in torque generated by individual UL joints. We observed preferential resultant action of proximal muscles and joints with stimulation at the rostral site, and of proximal joints with rostral-lateral stimulation. Robotic assessment can be used to measure the effects of TSS, and could be integrated into complex control algorithms that govern the behavior of hybrid neuromodulation-robotic systems.

Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices.

The tibial nerve is an established target for neuromodulation in the management of overactive bladder (OAB) and its associated symptoms, including urge urinary incontinence (UUI). Technologies are currently available to deliver tibial nerve stimulation (TNS) through percutaneous devices or through implantable devices. The benefits and safety of percutaneous TNS have led to it as a guideline-recommended therapy. However, patient compliance is limited by the burden of weekly office visits and the need for maintenance treatments. Further, insurance often only covers a limited number of lifetime visits for percutaneous TNS. These factors and others have led to the development, study, and utilization of implantable TNS devices. Implantable TNS devices deliver the same therapeutic mechanism of action for nerve stimulation with a permanent implanted device that provides at-home stimulation rather than in-office therapy delivery. Additionally, there is an added potential for dynamic and patient-centered stimulation. There is a large body of high-quality evidence published for TNS, including numerous randomized controlled trials published on percutaneous TNS which have consistently demonstrated superior efficacy to sham and similar efficacy to that of anticholinergic medications. Percutaneous TNS also performs better than conservative therapy including pelvic floor muscle training. The percutaneous and implantable approaches deliver nerve stimulation to the same target nerve, using the same mechanism of action. Therefore, data from randomized trials of percutaneous TNS are informative for implantable TNS devices. At the time of this article's publication, at least two implantable TNS devices have received marketing authorization from the Food and Drug Administration (FDA). The objective of this review is to discuss the mechanism of action for TNS and summarize the published literature from clinical trials of percutaneous TNS as a foundation of high-quality evidence for implantable devices targeting the tibial nerve.

Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder.

OBJECTIVE: To evaluate the efficacy and safety of a wearable, smartphone-controlled, rechargeable transcutaneous tibial nerve stimulation (TTNS) device in patients with overactive bladder (OAB). PATIENTS AND METHODS: This multicentre, prospective, single-blind, randomised clinical trial included eligible patients with OAB symptoms who were randomly assigned to the stimulation group or sham group. The primary efficacy outcome was change from baseline in voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy outcomes included changes in bladder diary outcomes (urgency score/void, nocturia episodes/day, micturition volume/void, and incontinence episodes/day), questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), and American Urological Association Symptom Index Quality of Life Score (AUA-SI-QoL) at baseline and after 4 weeks of treatment. Device-related adverse events (AEs) were also evaluated. RESULTS: In the full analysis set (FAS), the mean (sd) change of voiding frequency/24 h in the stimulation group and sham group at 4 weeks were -3.5 (2.9) and -0.6 (2.4), respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): -3.5 (2.9) vs -0.4 (2.3) (P < 0.01). In the FAS and PPS, micturition volume/void significantly improved at 4 weeks (P = 0.01 and P = 0.02). PPBC improvement almost reached significance in the FAS (P = 0.05), while it was significant in the PPS (P = 0.02). In the FAS and PPS, AUA-SI-QoL significantly improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas there were no significant differences in urgency score/void, nocturia episodes/day or OABSS between the groups. Also, no device-related serious AEs were reported. CONCLUSIONS: The non-invasive neuromodulation technique using the novel ambulatory TTNS device is effective and safe for treating OAB. Its convenience and easy maintenance make it a new potential home-based treatment modality. Future studies are warranted to confirm its longer-term efficacy.

Estimulação elétrica nervosa transcutânea (tens) e ultrassom para os sintomas da síndrome do intestino irritável: um estudo de caso / Transcutaneous nervous electrical stimulation (tens) and ultrasound for irritable bowel syndrome symptoms: a case study / Estimulación nerviosa eléctrica transcutánea (tens) y ultrasonido para los síntomas del síndrome del intestino irritable: un estudio de casos

Introdução: O intestino é um órgão vital, entretanto, seu mau funcionamento pode gerar alguns distúrbios como por exemplo, "A síndrome do intestino irritável". O quadro desses pacientes são dores na barriga, inchaço abdominal e alteração na frequência das evacuações e na consistência das fezes. A fisioterapia tem apresentado meios que favorecem analgesia. Objetivo: Verificar os efeitos da Estimulação Elétrica Nervosa Transcutânea (TENS) e do Ultrassom (US) nos sintomas da síndrome do intestino irritável. Método: Foi utilizado o TENS na região abdominal, durante 15 minutos. O Ultrassom foi usado durante 3 minutos em cada região abdominal, somando 12 minutos ao total. O tratamento foi realizado durante um mês, com 9 sessões. Utilizou-se a Escala Visual Analógica (EVA) e o questionário Inflammatory Bowel Disease Questionnaire (IBDQ). Resultados: Nos sintomas intestinais obteve-se progresso de 5 pontos no questionário IBDQ e nos sintomas emocionais houve uma evolução de 9 pontos, sendo este, estatisticamente significante. Na escala EVA a média de escore diminui de 5,6 para 3,6 ao final da intervenção. Conclusão: A intervenção fisioterapêutica surtiu efeitos positivos e contribuiu para a diminuição da dor e os outros sintomas como: inchaço abdominal e diminuição na quantidade de evacuações e essa evolução auxiliou na qualidade de vida do voluntário.

Introduction: The intestine is a vital organ, however, due to its malfunction, some disorders appear, for example, "The irritable bowel syndrome", patients with this syndrome experience pain in the belly, abdominal swelling, changes in the frequency of bowel movements and stool consistency. Physiotherapy uses means that help to cause analgesia. Objective: To verify the effects of TENS and Ultrasound on the symptoms of the individual with irritable bowel syndrome, contributing to the quality of life. Method: TENS was used in the abdominal region in Burst mode with a frequency of 150Hz with amplitude until it caused a slight contraction, for 15 minutes. Ultrasound was used in continuous mode with a frequency of 1MHZ, with a dose of 0.5w / cm2, for 3 minutes in each abdominal region, adding 12 minutes to the total. The treatment was carried out for one month, with 9 sessions. The EVA scale and the IBDQ questionnaire were used. Results: In the intestinal symptoms there was an improvement of 5 points in the IBDQ questionnaire and in the emotional aspect there was an improvement of 9 points and in the emotional aspect it was statistically significant, passing through the Wilcoxon test, P (est.) = 0.031 P (exact) ) = 0.031. On the EVA scale, the mean score before the intervention was 5.6 and at the end 3.6. Conclusion: The physical therapy intervention had positive effects, helping to reduce pain and other symptoms such as:abdominal swelling, decrease in the amount of bowel movements and this improvement helped the individual's emotional state, however a study on the subject is still necessary.

Introducción: El intestino es un órgano vital, sin embargo, su mal funcionamiento puede generar algunos trastornos como el "síndrome del intestino irritable". Los síntomas de estos pacientes son dolor de estómago, hinchazón abdominal y alteración de la frecuencia de las deposiciones y de la consistencia de las heces. La fisioterapia ha presentado medios que favorecen la analgesia. Objetivo: Verificar los efectos de la Estimulación Nerviosa Eléctrica Transcutánea (TENS) y el Ultrasonido (US) en los síntomas del síndrome del intestino irritable. Método: Se utilizó TENS en la región abdominal durante 15 minutos. Los ultrasonidos se utilizaron durante 3 minutos en cada región abdominal, sumando 12 minutos en total. El tratamiento se llevó a cabo durante un mes, con 9 sesiones. Se utilizaron la Escala Visual Analógica (EVA) y el Cuestionario de Enfermedad Inflamatoria Intestinal (IBDQ). Resultados: En los síntomas intestinales hubo una progresión de 5 puntos en el cuestionario IBDQ y en los síntomas emocionales hubo una evolución de 9 puntos, siendo esto, estadísticamente significativo. En la escala VAS, la puntuación media disminuyó de 5,6 a 3,6 al final de la intervención. Conclusión: La intervención fisioterapéutica tuvo efectos positivos y contribuyó a la reducción del dolor y de otros síntomas como: hinchazón abdominal y disminución de la cantidad de deposiciones y esta evolución ayudó a la calidad de vida del voluntario.

Output of Electronic Muscle Stimulators: Physical Therapy and Police Models Compared.

INTRODUCTION: Both physical therapists and police officers use electrical muscle stimulation. The typical physical therapist unit is attached with adhesive patches while the police models use needle-based electrodes to penetrate clothing. There have been very few papers describing the outputs of these physical therapy EMS (electrical muscle stimulator) units. METHODS: We purchased 6 TENS/EMS units at retail and tested them with loads of 500 Ω, 2 kΩ, and 10 kΩ. RESULTS: For the typical impedance of 500 Ω, the EMS units delivered the most current followed by the electrical weapons; TENS units delivered the least current. At higher im-pedances (> 2 kΩ) the electrical weapons delivered more current than the EMS units, which is explained by the higher voltage-compliance of their circuits. Some multi channel EMS units deliver more calculated muscle stimula tion than the multi-channel weapons. CONCLUSION: Present therapeutic electrical muscle stimula-tors can deliver more current than present law-enforcement muscle stimulators.

Stretchable, Fully Polymeric Electrode Arrays for Peripheral Nerve Stimulation.

There is a critical need to transition research level flexible polymer bioelectronics toward the clinic by demonstrating both reliability in fabrication and stable device performance. Conductive elastomers (CEs) are composites of conductive polymers in elastomeric matrices that provide both flexibility and enhanced electrochemical properties compared to conventional metallic electrodes. This work focuses on the development of nerve cuff devices and the assessment of the device functionality at each development stage, from CE material to fully polymeric electrode arrays. Two device types are fabricated by laser machining of a thick and thin CE sheet variant on an insulative polydimethylsiloxane substrate and lamination into tubing to produce pre-curled cuffs. Device performance and stability following sterilization and mechanical loading are compared to a state-of-the-art stretchable metallic nerve cuff. The CE cuffs are found to be electrically and mechanically stable with improved charge transfer properties compared to the commercial cuff. All devices are applied to an ex vivo whole sciatic nerve and shown to be functional, with the CE cuffs demonstrating superior charge transfer and electrochemical safety in the biological environment.

Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study.

BACKGROUND: Percutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption. METHODS: Preoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days. RESULTS: During the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001). CONCLUSIONS: Percutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.

Noninvasive Neuroprosthesis Promotes Cardiovascular Recovery After Spinal Cord Injury.

Spinal cord injury (SCI) leads to severe impairment in cardiovascular control, commonly manifested as a rapid, uncontrolled rise in blood pressure triggered by peripheral stimuli-a condition called autonomic dysreflexia. The objective was to demonstrate the translational potential of noninvasive transcutaneous stimulation (TCS) in mitigating autonomic dysreflexia following SCI, using pre-clinical evidence and a clinical case report. In rats with SCI, we show that TCS not only prevents the instigation of autonomic dysreflexia, but also mitigates its severity when delivered during an already-triggered episode. Furthermore, when TCS was delivered as a multisession therapy for 6 weeks post-SCI, the severity of autonomic dysreflexia was significantly reduced when tested in the absence of concurrent TCS. This treatment effect persisted for at least 1 week after the end of therapy. More importantly, we demonstrate the clinical applicability of TCS in treatment of autonomic dysreflexia in an individual with cervical, motor-complete, chronic SCI. We anticipate that TCS will offer significant therapeutic advantages, such as obviating the need for surgery resulting in reduced risk and medical expenses. Furthermore, this study provides a framework for testing the potential of TCS in improving recovery of other autonomic functions such lower urinary tract, bowel, and sexual dysfunction following SCI.

A device review of Relivion®: an external combined occipital and trigeminal neurostimulation (eCOT-NS) system for self-administered treatment of migraine and major depressive disorder.

Introduction: Many patients with migraine are non-responsive or intolerant to pharmaceutical or surgical interventions. Peripheral nerve stimulation (PNS) offers a potential solution for these patients. This review discusses the external combined occipital and trigeminal neurostimulation (eCOT-NS) provided by the Relivion®, a multi-channel head-mounted device for self-administered PNS.Areas covered: Challenges and advantages of PNS systems for the treatment of migraine and depression are introduced, followed by an overall review of clinical evidence of the efficacy of the Relivion® system in treating migraine. The supporting smartphone app and cloud-based analytics which enable remote treatment management by the health care provider are also discussed. Recent empirical indications for the potency of this PNS combination for the treatment of depression are also summarized.Expert opinion: Relivion® is an eCOT-NS system, featuring Food and Drug Administration-approved, noninvasive, self-administered, customizable, multi-focal PNS for the treatment of migraine. In accordance with current telehealth trends, the Relivion® also enhances remote disease management and personalization using digital-monitoring, cloud-based technology, and artificial intelligence. As research on this system progresses, it may become the preferred treatment for the management of a number of neurological and psychiatric diseases, with migraine and major depressive disorders as precedents.

Optimizing Location of Subdermal Recording Electrodes for Intraoperative Facial Nerve Monitoring.

OBJECTIVE: The purpose of this study is to determine if different facial muscle groups demonstrate different responses to facial nerve stimulation, the results of which could potentially improve intraoperative facial nerve monitoring (IOFNM). METHODS: IOFNM data were prospectively collected from patients undergoing cochlear implantation. At different stages of nerve exposure, three sites were stimulated using a monopolar pulse. Peak electromyography (EMG) amplitude (µV) in four muscle groups innervated by four different branches of the facial nerve (frontalis-temporal, inferior orbicularis oculi-zygomatic, superior oribularis oris-buccal, and mentalis-marginal mandibular) were recorded. RESULTS: A total of 279 peak EMG amplitudes were recorded in 93 patients. At all three stimulating sites, the zygomatic branch mean peak EMG amplitudes were statistically greater than those of the temporal, buccal, and marginal mandibular branches (P < .05). At stimulating Site C, the marginal mandibular branch mean peak EMG was stronger than the temporal or buccal branches (P < .05). Of the 279 stimulations, the zygomatic branch demonstrated the highest amplitude in 128 (45.9%) trials, followed by the marginal mandibular branch (22.2%). CONCLUSIONS: When utilized, IOFNM should be performed with at least two electrodes, one of which is placed in the orbicularis oculi muscles and the other in the mentalis muscle. However, there is wide variability between patients. As such, in cases of suspected variant nerve anatomy or increased risk of injury (intradural procedures), surgeons should consider using more than two recording electrodes, with at least one in the orbicularis oculi muscle. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:E2329-E2334, 2021.

Acute postoperative pain management with percutaneous peripheral nerve stimulation: the SPRINT neuromodulation system.

INTRODUCTION: Ultrasound-guided percutaneous peripheral nerve stimulation (PNS) may be used to treat acute postoperative pain for various types of surgeries. This modality avoids several limitations of traditional local anesthetic-based peripheral nerve blocks including avoidance of motor blockade and sensory deficits. AREAS COVERED: In this review, we discuss the use of SPRINT (SPR Therapeutics, Cleveland, OH) neuromodulation system in the setting of acute postoperative pain management. EXPERT OPINION: PNS is a novel modality in regional anesthesia that has much promise in reducing overall opioid use after surgery. Placement of PNS is very similar to that of catheter-based regional anesthesia techniques. Ultrasound is used to guide the percutaneously placed introducer needle in proximity to the target nerve. There are several benefits of PNS over catheter-based approaches, including: 1) avoidance of motor or sensory blockade; 2) no medication bag required to be carried; and 3) electric leads may be kept in situ safely for up to 60 days. While several proof-of-concept studies have been published highlighting its use in various types of surgeries, large high-quality randomized controlled trials are still needed.

Sacral Neuromodulation: Determining Predictors of Success.

OBJECTIVE: To determine predictors of success for sacral neuromodulation in women with overactive bladder, urinary retention, and fecal incontinence. METHODS: A retrospective chart review was performed on women who underwent a staged sacral neuromodulation implantation between 2007 and 2018. Clinical and procedural characteristics were recorded. Presence of intraoperative motor responses in either all 4 or <4 electrodes were used to group women. Endpoints included completion of stage II implant, tined lead revision, and patient-reported success. RESULTS: In 198 women with a mean age of 62.9 years (SD+/- 14.7), completion of stage II implant occurred in 92.4% of women, and 83.3% of these women reported success at the first postoperative visit. Continued success at 6 months was reported in 70.3%. Lead revision was noted in 23.0%. Age >65 years (odds ratio [OR] = 0.2, 95% confidence interval [CI] = 0.06-0.8) and prior onabotulinumtoxinA (onaBoNT-A) (OR = 0.2, 95% CI = 0.06-0.9) were negative predictors for completion of stage II implant on multivariable analysis. Also, prior pelvic floor physical therapy was a significant negative predictor of postoperative patient-reported success on multivariable analysis (OR = 0.25, 95% CI = 0.1-0.6). There were no differences seen in women who had motor responses with either all 4 electrodes or <4 electrodes in any endpoint (P > .05). CONCLUSION: Patient age >65 and history of prior onaBoNT-A were associated with failure to complete stage II implant. Women with prior pelvic floor physical therapy were less likely to report success after sacral neuromodulation. Motor responses in <4 electrodes during lead testing did not impact patient-reported success.

Remote electrical neuromodulation for acute treatment of migraine in adolescents.

OBJECTIVES: Migraine is a common disabling neurological disorder. Current acute treatments for migraine in adolescents are mostly pharmacological and may have limited effectiveness, can cause side effects, and may lead to medication overuse. There is an unmet need for effective and well-tolerated treatments. Remote electrical neuromodulation (REN) is a novel acute treatment of migraine that stimulates upper arm peripheral nerves to induce conditioned pain modulation (CPM)-an endogenous analgesic mechanism. The REN device (Nerivio® , Theranica Bio-Electronics Ltd., Israel) is a FDA-authorized device for acute treatment of migraine in adults. This study assessed the efficacy and safety of REN in adolescents with migraine. DESIGN AND METHODS: This was an open-label, single-arm, multicenter study in adolescents (ages 12-17 years) with migraine. Participants underwent a 4-week run-in phase. Eligible participants continued to an 8-week treatment phase with the device. Pain severity, associated symptoms, and functional disability were recorded at treatment initiation, and 2 and 24 hours post-treatment. The primary endpoints of this study were related to the safety and tolerability of REN. The secondary endpoints were related to device efficacy and included the proportion of participants who achieved pain relief at 2 hours post-treatment and the proportion of participants who achieved pain freedom at 2 hours. The presented results reflect an interim analysis with subsequent stopping of the rest of the study. RESULTS: Sixty participants were enrolled for the study; of these, 14 failed to meet the run-in criteria and 1 was lost to follow-up. Forty-five participants performed at least one treatment, of which 39 participants completed a test treatment with REN. One device-related adverse event (2%) was reported in which a temporary feeling of pain in the arm was felt. Pain relief and pain-free at 2 hours were achieved by 71% (28/39) and 35% (14/39) participants, respectively. At 2 hours, 69% (23/33) participants experienced improvement in functional ability. CONCLUSIONS: REN may offer a safe and effective non-pharmacological alternative for acute treatment in adolescents.

Effectiveness of Transcutaneous Electrical Nerve Stimulation Therapy on whole Salivary Flow in Patients with Xerostomia and Healthy Adults

ABSTRACT Objective: To evaluate and compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) therapy on whole salivary flow in patients with xerostomia and healthy adults. Material and Methods: Thirty subjects with a history of xerostomia and subjects withunstimulated salivary flow equal to or less than 0.5 ml in 5 min were included in the study group, and 30 healthy subjects were included in the control group. Low forced spitting unstimulated saliva was collected for five minutes in a test tube fitted with a funnel. Then electrode pads of the TENS unit were applied bilaterally on skin overlying the parotid glands and at optimal intensity, stimulated saliva was collected for 5 minutes with the same method in a separate graduated test tube. The salivary flow rate (per minute) was calculated by dividing the amount of collected saliva (volume in mL) by the duration of collection period (5 minutes) and the salivary flow rates prior and after electrostimulation were compared for both groups. The Student's t-test (unpaired and paired) was performed for group-wise comparisons. Results: In study group, the mean unstimulated salivary flow rate was 0.07 ± 0.01 mL/min. There was an 85.71% increase in salivary flow (0.13 ± 0.03 mL/min) during the TENS application and the difference was highly significant (p<0.001). In control group, the mean unstimulated salivary flow rate was 0.37 ± 0.07 mL/min. There was a 21.62% increase in salivary flow (0.45 ± 0.07 mL/min) during the TENS application and the difference was highly significant (p<0.001). An increase in mean salivary flow rate both in males and females after TENS application in both groups (p<0.001) was noted. The difference between unstimulated, stimulated and mean difference in salivary flow rate between males and females was notstatistically significant in both groups (p<0.05). Conclusion: TENS can be an effective therapy in increasing whole salivary flow rates in patients with xerostomia.

Design and Implementation of an Intelligent Analgesic Bracelet Based on Wrist-ankle Acupuncture.

A flexible, multifunctional, and intelligent analgesic bracelet was proposed in this article to alleviate symptoms of pain. Based on the theory of wrist-ankle acupuncture in traditional Chinese medicine, transcutaneous electrical nerve stimulation is the technical basis of the method. A set of targeted circuit system capable of generating adjustable electrical stimulation signals to simulate filamentary acupuncture was designed. The system architecture includes a wireless communication module, a signal control module, a stimulus signal generation module, and a wearable, flexible bracelet. In addition, a pain assessment interface with a visual analog scale was designed to assess pain levels. Two comparative experiments were designed, involving a custom pain assessment scale and hand-held dolorimeter that were performed before and after wearing the bracelet to verify the analgesic effect of the bracelet. The results showed that the wrist-worn analgesic bracelet is significantly effective in alleviating pain in various parts of the human body.

Long-Term Non Anesthetic Preclinical Study Available Extra-Cranial Brain Activator (ECBA) System for the Future Minimally Invasive Human Neuro Modulation.

In recent years, electroceuticals have been spotlighted as an emerging treatment for various severe chronic brain diseases, owing to their intrinsic advantage of electrical interaction with the brain, which is the most electrically active organ. However, the majority of research has verified only the short-term efficacy through acute studies in laboratory tests owing to the lack of a reliable miniaturized platform for long-term animal studies. The construction of a sufficient integrated system for such a platform is extremely difficult because it requires multi-disciplinary work using state-of-the-art technologies in a wide range of fields. In this study, we propose a complete system of an implantable platform for long-term preclinical brain studies. Our proposed system, the extra-cranial brain activator (ECBA), consists of a titanium-packaged implantable module and a helmet-type base station that powers the module wirelessly. The ECBA can also be controlled by a remote handheld device. Using the ECBA, we performed a long-term non-anesthetic study with multiple canine subjects, and the resulting PET-CT scans demonstrated remarkable enhancement in brain activity relating to memory and sensory skills. Furthermore, the histological analysis and high-temperature aging test confirmed the reliability of the system for up to 31 months. Hence, the proposed ECBA system is expected to lead a new paradigm of human neuromodulation studies in the near future.

Transcutaneous auricular vagus nerve stimulation enhances learning of novel letter-sound relationships in adults.

BACKGROUND: Reading is a critical skill in modern society but is significantly more difficult to acquire during adulthood. Many adults are required to learn a new orthography after this window closes for personal or vocational reasons and while many programs and training methods exist for learning to read in adulthood, none result in native-like fluency. Implantable cervical vagus nerve stimulation is capable of driving neural plasticity but is invasive and not practical as a reading intervention. OBJECTIVE: The goal of the current study was to evaluate whether non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) is effective at enhancing novel orthography acquisition in young adults. METHODS: We enrolled 37 typically developing participants and randomly assigned them to a computer control, device sham control, earlobe stimulation control, or experimental transcutaneous auricular stimulation (taVNS) group. Participants then learned novel letter-sound correspondences in Hebrew over five training lessons. Performance was assessed using three measures to evaluate various aspects of reading: Letter ID, Automaticity, and Decoding. RESULTS: The taVNS group significantly outperformed the three control groups on both the Automaticity and Decoding tasks. There was no difference on the Letter ID task. CONCLUSIONS: These results demonstrate, for the first time, that taVNS is capable of improving aspects of reading acquisition in adults. These findings have potential implications for a wide range of cognitive tasks.

Update on noninvasive neuromodulation for migraine treatment-Vagus nerve stimulation.

Noninvasive neurostimulation methods are particularly suited for migraine treatment thanks to their most favorable adverse event profile. Among them, noninvasive vagus nerve stimulation (nVNS) has raised great hope because of the role the vagus nerve is known to play in pain modulation, inflammation and brain excitability. We will critically review the clinical studies performed for migraine attack treatment and migraine prevention with the GammaCore® device, which allows cervical vagus nerve stimulation. nVNS is effective for the abortive treatment of migraine attacks, although the effect size is modest and numbers-to-treat appear not superior to those of other noninvasive neurostimulation methods, and inferior to those of oral triptans. The effect of nVNS with the GammaCore® in migraine prevention is not superior to sham stimulation, except possibly in patients with high adherence to the treatment. Both in acute and preventive trials, nVNS was characterized by an outstanding tolerance and safety profile, like the other noninvasive neurostimulation techniques. In physiological animal and human studies, cervical nVNS was shown to generate somatosensory evoked responses, to modulate pain perception and several areas of the cerebral pain network, and to inhibit experimental cortical spreading depression, which are relevant effects for migraine therapy.

Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke.

BACKGROUND: Spasticity after lesions of central motor pathways may be disabling and there is a need for new, cost-effective treatment methods. One novel approach is offered by the electro-dress Mollii®, primarily designed to enhance reciprocal inhibition of spastic muscles by multifocal, transcutaneous antagonist stimulation. METHODS: The Mollii® suit was set individually for 20 participants living with spasticity and hemiplegia after stroke and used in the home setting for 6 weeks. Usability and perceived effects were monitored by weekly telephone interviews. Outcome was assessed by use of the NeuroFlexor™ method for quantification of the neural component (NC) of resistance to passive stretch (spasticity), and the modified Ashworth scale (MAS) for total resistance, Fugl-Meyer Assessment of motor recovery for sensorimotor function in upper (FM-UE) and lower extremities (FM-LE), activity performance with the Action Research Arm Test (ARAT), Berg balance scale, 10 m and 6 min walk tests, and perceived functioning with the Stroke Impact Scale. RESULTS: Compliance was high (mean 19.25 of 21 sessions). Perceived positive effects were reported by 60% and most commonly related to decreased muscle tone (n = 9), improved gait pattern function (n = 7) and voluntary movement in the upper extremity (n = 6). On a group level, the NC decreased significantly in the wrist flexors of the affected hand (p = 0.023) and significant improvements according to FM-UE (p = 0.000) and FM-LE (p = 0.003) were seen after the intervention. No significant difference was detected with MAS or assessed activity performance, except for the ARAT (p = 0.000). FM-UE score change correlated significantly and fairly with the perceived effect in the upper extremity (r 0.498 p = 0.025) and in the corresponding analysis for the FM-LE and perceived effect in the lower extremity (r = 0.469 p = 0.037). CONCLUSION: This study indicates that the Mollii® method is feasible when used in the home setting to decrease spasticity and improve sensorimotor function. The results may guide a larger controlled study combined with rehabilitation interventions to enhance effects on activity and participation domains. TRIAL REGISTRATION: NCT04076878 . Registered 2 September 2019 - Retrospectively registered.

Estimulación no invasiva cerebral y medular para la recuperación motora y funcional tras una lesión medular / Non-invasive brain and spinal cord stimulation for motor and functional recovery after a spinal cord injury

INTRODUCCIÓN: La lesión medular es un evento traumático o no traumático que causa una alteración de la función sensorial, motora o autonómica y, en última instancia, afecta a las características físicas, psicológicas y el bienestar social de la persona que lo sufre. El abordaje integral de la lesión medular requiere muchos recursos de salud y puede representar una considerable carga financiera para los pacientes, sus familias y la comunidad. OBJETIVO: Revisar la bibliografía publicada sobre el uso de la estimulación cerebral no invasiva, incluida la estimulación magnética transcraneal repetitiva (EMTr), la estimulación de corriente continua directa transcraneal (tDCS), así como la estimulación medular no invasiva transcutánea (tcSCS), como estrategias terapéuticas para mejorar la funcionalidad de los pacientes con lesión medular. Los estudios se agruparon bien como de estimulación no invasiva cerebral, bien como de estimulación medular no invasiva. DESARROLLO: Se identificaron 32 estudios: 21 de estimulación cerebral (14 en EMTr y 7 en tDCS) y 11 de estimulación medular (tcSCS). Todos los estudios se realizaron en pacientes adultos que sufrieron una lesión medular. A pesar de la variabilidad significativa en los protocolos de tratamiento, las características de los pacientes y la evaluación clínica, los cambios observados se describieron en casi todos los estudios sin producir efectos secundarios con mejoría motora o funcional. CONCLUSIÓN: La estimulación cerebral no invasiva, así como la estimulación medular, son técnicas prometedoras para la rehabilitación de pacientes con lesión medular debido a su novedad, su efectividad y mínimos efectos secundarios

INTRODUCTION: Spinal cord injury is a traumatic or non-traumatic event that causes an alteration of sensory, motor or autonomic functioning and ultimately affects the physical, psychological and social well-being of the person who suffers it. A comprehensive approach to spinal cord injury requires many health resources and can place a considerable financial burden on patients, their families and the community. AIM: To review the literature published to date on the use of non-invasive brain stimulation, including repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), and transcutaneous non-invasive spinal cord stimulation (tcSCS), as therapeutic strategies to improve the functionality of patients with spinal cord injury. The studies were grouped as addressing either non-invasive brain stimulation or non-invasive spinal cord stimulation. DEVELOPMENT: Altogether 32 studies were identified: 21 involving brain stimulation (14 in rTMS and 7 in tDCS) and 11 with spinal cord stimulation (tcSCS). All the studies were conducted in adult patients who had undergone a spinal cord injury. Despite significant variability in treatment protocols, patient characteristics and clinical assessment, the changes observed were reported in almost all the studies without producing any side effects and with motor or functional improvement. CONCLUSION: Non-invasive brain stimulation, as well as spinal cord stimulation, are promising techniques for the rehabilitation of patients with spinal cord injury due to their novelty, effectiveness and minimal side effects