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1.
PLoS One ; 19(8): e0296613, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39213293

RESUMEN

BACKGROUND: Transcutaneous spinal stimulation (TSS) and neuromuscular electrical stimulation (NMES) can facilitate self-assisted standing in individuals with paralysis. However, individual variability in responses to each modality may limit their effectiveness in generating the necessary leg extension force for full body weight standing. To address this challenge, we proposed combining TSS and NMES to enhance leg extensor muscle activation, with optimizing timing adjustment to maximize the interaction between the two modalities. METHODS: To assess the effects of TSS and NMES on knee extension and plantarflexion force, ten neurologically intact participants underwent three conditions: (1) TSS control, (2) NMES control, and (3) TSS + NMES. TSS was delivered between the T10 and L2 vertebrae, while NMES was delivered to the skin over the right knee extensors and plantarflexors. TSS and NMES were administered using a 15 Hz train of three 0.5 ms biphasic pulses. During the TSS + NMES condition, the timing between modalities was adjusted in increments of » the interval within a 15 Hz frequency, i.e., 66, 49.5, 33, 16.5, and 1 ms. RESULTS: NMES combined with TSS, produced synergistic effects even on non-targeted muscle groups, thereby promoting leg extension across multiple joints in the kinematic chain. The sequence of NMES or TSS trains relative to each other did not significantly impact motor output. Notably, a delay of 16.5 to 49.5 ms between interleaved TSS and NMES pulses, each delivered at 15 Hz, results in more robust and synergistic responses in knee extensors and plantarflexors. CONCLUSIONS: By adjusting the timing between TSS and NMES, we can optimize the combined use of these modalities for functional restoration. Our findings highlight the potential of integrated TSS and NMES protocols to enhance motor function, suggesting promising avenues for therapeutic applications, particularly in the rehabilitation of individuals with SCI.


Asunto(s)
Extremidad Inferior , Estimulación Eléctrica Transcutánea del Nervio , Humanos , Masculino , Femenino , Adulto , Extremidad Inferior/fisiología , Estimulación Eléctrica Transcutánea del Nervio/métodos , Músculo Esquelético/fisiología , Adulto Joven , Terapia por Estimulación Eléctrica/métodos , Electromiografía , Estimulación de la Médula Espinal/métodos
2.
Artículo en Inglés | MEDLINE | ID: mdl-39088505

RESUMEN

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.


Asunto(s)
Electromiografía , Dispositivo Exoesqueleto , Robótica , Traumatismos de la Médula Espinal , Torque , Extremidad Superior , Humanos , Robótica/instrumentación , Masculino , Adulto , Traumatismos de la Médula Espinal/rehabilitación , Femenino , Fenómenos Biomecánicos , Músculo Esquelético/fisiología , Médula Cervical , Voluntarios Sanos , Estimulación de la Médula Espinal/instrumentación , Estimulación de la Médula Espinal/métodos , Adulto Joven , Estimulación Eléctrica Transcutánea del Nervio/instrumentación , Estimulación Eléctrica Transcutánea del Nervio/métodos , Vértebras Cervicales , Algoritmos
3.
J Neural Eng ; 21(4)2024 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-39094627

RESUMEN

Objective. Phantom limb pain (PLP) is debilitating and affects over 70% of people with lower-limb amputation. Other neuropathic pain conditions correspond with increased spinal excitability, which can be measured using reflexes andF-waves. Spinal cord neuromodulation can be used to reduce neuropathic pain in a variety of conditions and may affect spinal excitability, but has not been extensively used for treating PLP. Here, we propose using a non-invasive neuromodulation method, transcutaneous spinal cord stimulation (tSCS), to reduce PLP and modulate spinal excitability after transtibial amputation.Approach. We recruited three participants, two males (5- and 9-years post-amputation, traumatic and alcohol-induced neuropathy) and one female (3 months post-amputation, diabetic neuropathy) for this 5 d study. We measured pain using the McGill Pain Questionnaire (MPQ), visual analog scale (VAS), and pain pressure threshold (PPT) test. We measured spinal reflex and motoneuron excitability using posterior root-muscle (PRM) reflexes andF-waves, respectively. We delivered tSCS for 30 min d-1for 5 d.Main Results. After 5 d of tSCS, MPQ scores decreased by clinically-meaningful amounts for all participants from 34.0 ± 7.0-18.3 ± 6.8; however, there were no clinically-significant decreases in VAS scores. Two participants had increased PPTs across the residual limb (Day 1: 5.4 ± 1.6 lbf; Day 5: 11.4 ± 1.0 lbf).F-waves had normal latencies but small amplitudes. PRM reflexes had high thresholds (59.5 ± 6.1µC) and low amplitudes, suggesting that in PLP, the spinal cord is hypoexcitable. After 5 d of tSCS, reflex thresholds decreased significantly (38.6 ± 12.2µC;p< 0.001).Significance. These preliminary results in this non-placebo-controlled study suggest that, overall, limb amputation and PLP may be associated with reduced spinal excitability and tSCS can increase spinal excitability and reduce PLP.


Asunto(s)
Amputación Quirúrgica , Miembro Fantasma , Estimulación de la Médula Espinal , Humanos , Miembro Fantasma/fisiopatología , Masculino , Femenino , Estimulación de la Médula Espinal/métodos , Amputación Quirúrgica/efectos adversos , Amputación Quirúrgica/métodos , Persona de Mediana Edad , Médula Espinal/fisiopatología , Médula Espinal/fisiología , Adulto , Tibia/cirugía , Estimulación Eléctrica Transcutánea del Nervio/métodos , Dimensión del Dolor/métodos , Resultado del Tratamiento
4.
PLoS One ; 19(8): e0308556, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39116099

RESUMEN

Diabetic Peripheral Neuropathy (DPN) is a prevalent and debilitating complication of diabetes, affecting a significant proportion of the diabetic population. Neuromodulation, an emerging therapeutic approach, has shown promise in the management of DPN symptoms. This systematic review aims to synthesize and analyze the current advancements in neuromodulation techniques for the treatment of DPN utilizing studies with preclinical animal models. A comprehensive search was conducted across multiple databases, including PubMed, Scopus, and Web of Science. Inclusion criteria were focused on studies utilizing preclinical animal models for DPN that investigated the efficacy of various neuromodulation techniques, such as spinal cord stimulation, transcranial magnetic stimulation, and peripheral nerve stimulation. The findings suggest that neuromodulation significantly alleviated pain symptoms associated with DPN. Moreover, some studies reported improvements in nerve conduction velocity and reduction in nerve damage. The mechanisms underlying these effects appeared to involve modulation of pain pathways and enhancement of neurotrophic factors. However, the review also highlights the variability in methodology and stimulation parameters across studies, highlighting the need for standardization in future research. Additionally, while the results are promising, the translation of these findings from animal models to human clinical practice requires careful consideration. This review concludes that neuromodulation presents a potentially effective therapeutic strategy for DPN, but further research is necessary to optimize protocols and understand the underlying molecular mechanisms. It also emphasizes the importance of bridging the gap between preclinical findings and clinical applications to improve the management of DPN in diabetic patients.


Asunto(s)
Neuropatías Diabéticas , Modelos Animales de Enfermedad , Investigación Biomédica Traslacional , Animales , Neuropatías Diabéticas/terapia , Neuropatías Diabéticas/fisiopatología , Humanos , Estimulación de la Médula Espinal/métodos , Estimulación Magnética Transcraneal/métodos
5.
Pain Physician ; 27(5): 309-316, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39087966

RESUMEN

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.


Asunto(s)
Dolor Crónico , Estudios Cruzados , Estimulación de la Médula Espinal , Humanos , Femenino , Masculino , Persona de Mediana Edad , Dolor Crónico/terapia , Estudios Prospectivos , Método Simple Ciego , Estimulación de la Médula Espinal/métodos , Adulto , Dolor de la Región Lumbar/terapia , Dimensión del Dolor , Anciano , Terapia por Estimulación Eléctrica/métodos , Terapia por Estimulación Eléctrica/instrumentación , Resultado del Tratamiento
6.
Pain Physician ; 27(5): E611-E618, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-39087974

RESUMEN

BACKGROUND: Spinal cord stimulation is an established technique wherein diverse electrode types are strategically implanted within the spinal epidural space for neuromodulation. Traditional percutaneous puncture cylindrical electrodes (PEs) are predominantly implanted by interventionalists utilizing a percutaneous technique under the monitor of radiation, which is a nonvisualized procedure. OBJECTIVE: Our study aimed to assess the feasibility of percutaneous endoscope-assisted visualized implantation approach for PEs, delineating its specific merits and demerits compared to the traditional method. STUDY DESIGN: Laboratory study with Institutional Review Board Number B2023-056SETTING: Clinical Anatomy Research Center, Fudan University. METHODS: Eight freshly procured adult cadavers (4 women and 4 men) were operated on in this study. They were divided into either Group A or Group B, each encompassing 4 cadavers. Group A was subjected to endoscope-assisted PEs implantation, whereas Group B followed the conventional PEs implantation route.In both groups the operative time of introducer needles placement (OTNP), total operative time (TOT), fluoroscopy time of introducer needles placement (FTNP), and total fluoroscopy time (TFT) were documented and analyzed. Furthermore, the precise positioning of the PEs and any ensuing complications were systematically examined. RESULTS: Both Group A and Group B successfully executed all predetermined surgical steps. A total of 16 PEs were implanted (dual electrodes in each cadaver): 8 using the percutaneous endoscope-assisted visualized approach (Group A) and 8 via the traditional methodology (Group B). Group A's mean ± SD durations for OTNP, TOT, FTNP, and TFT were 10.25 ± 1.03 minutes, 31.63 ± 5.87 minutes, 4.58 ± 1.35 seconds, and 43.73 ± 14.46 seconds, respectively. In contrast, Group B exhibited mean ± SD times of 11.55 ± 2.81 minutes, 44.75 ± 7.85 minutes, 23.53 ± 4.16 seconds, and 66.30 ± 6.35 seconds for the same metrics. No discernible statistical difference in OTNP and TOT emerged between the groups. However, Group A demonstrated reduced durations for both FTNP and TFT compared to Group B. The optimal position of the PEs was verified via fluoroscopy, with no recorded instances of dura rupture. These outcomes suggest that this endoscope-assisted technique neither increases surgical time nor compromises efficacy. Instead, it leads to a marked reduction in fluoroscopic duration relative to the traditional methodology. LIMITATIONS: Anatomical study on a human cadaver, the quantity of cadavers, and the procedure's steep learning curve. CONCLUSION: With the assistance of percutaneous spinal endoscopy, introducer needles can be punctured through the ligamentum flavum at the anticipated interlaminar window locus under direct visualization, improving the convenience of the puncture and reducing fluoroscopic exposure. It is a viable alternative for surgeons from diverse training backgrounds to implant PEs, particularly benefiting those well-versed in endoscopic spine surgery techniques.


Asunto(s)
Cadáver , Electrodos Implantados , Estudios de Factibilidad , Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Estimulación de la Médula Espinal/instrumentación , Femenino , Masculino , Endoscopía/métodos , Endoscopía/instrumentación
7.
PLoS One ; 19(8): e0302842, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39133680

RESUMEN

BACKGROUND: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. METHODS AND DESIGN: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. DISCUSSION: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023.


Asunto(s)
Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Manejo del Dolor/métodos , Calidad de Vida , Masculino , Femenino , Reducción Gradual de Medicamentos , Adulto , Persona de Mediana Edad , Dimensión del Dolor , Dolor Crónico/terapia , Dolor Crónico/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como Asunto , Analgésicos/administración & dosificación , Analgésicos/uso terapéutico
8.
BMC Neurol ; 24(1): 284, 2024 Aug 13.
Artículo en Inglés | MEDLINE | ID: mdl-39138444

RESUMEN

BACKGROUND: Central neuropathic pain after foramen magnum decompression (FMD) for Chiari malformation type 1 (CM-1) with syringomyelia can be residual and refractory. Here we present a case of refractory central neuropathic pain after FMD in a CM-1 patient with syringomyelia who achieved improvements in pain following spinal cord stimulation (SCS) using fast-acting sub-perception therapy (FAST™). CASE PRESENTATION: A 76-year-old woman presented with a history of several years of bilateral upper extremity and chest-back pain. CM-1 and syringomyelia were diagnosed. The pain proved drug resistant, so FMD was performed for pain relief. After FMD, magnetic resonance imaging showed shrinkage of the syrinx. Pain was relieved, but bilateral finger, upper arm and thoracic back pain flared-up 10 months later. Due to pharmacotherapy resistance, SCS was planned for the purpose of improving pain. A percutaneous trial of SCS showed no improvement of pain with conventional SCS alone or in combination with Contour™, but the combination of FAST™ and Contour™ did improve pain. Three years after FMD, percutaneous leads and an implantable pulse generator were implanted. The program was set to FAST™ and Contour™. After implantation, pain as assessed using the McGill Pain Questionnaire and visual analog scale was relieved even after reducing dosages of analgesic. No adverse events were encountered. CONCLUSION: Percutaneously implanted SCS using FAST™ may be effective for refractory pain after FMD for CM-1 with syringomyelia.


Asunto(s)
Malformación de Arnold-Chiari , Neuralgia , Estimulación de la Médula Espinal , Siringomielia , Humanos , Siringomielia/complicaciones , Femenino , Malformación de Arnold-Chiari/complicaciones , Malformación de Arnold-Chiari/cirugía , Anciano , Neuralgia/etiología , Neuralgia/terapia , Estimulación de la Médula Espinal/métodos , Dolor Postoperatorio/terapia , Dolor Postoperatorio/etiología , Resultado del Tratamiento
9.
Clin Neurol Neurosurg ; 244: 108438, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38981167

RESUMEN

BACKGROUND: Postherpetic neuralgia (PHN) after herpes zoster is a debilitating complication that severely affects the quality of life of patients. Neuromodulation such as spinal cord stimulation (SCS) and trigeminal semilunar ganglion stimulation (TSGS) have become effective methods for treating postherpetic neuralgia. METHODS: A retrospective analysis of clinical data from 30 patients with postherpetic neuralgia who underwent SCS or TSGS treatment from January 2022 to January 2024. Patients received conventional treatment before neuromodulation. Clinical data including patient age, gender, pain characteristics, treatment outcomes were collected. The efficacy was evaluated using the Visual Analog Scale (VAS) and the Modified Global Impression of Change scale. Optimal stimulation parameters were also analyzed. RESULTS: The results showed that postoperative pain was significantly reduced in both SCS and TSGS groups, with a higher satisfaction rate in the SCS group (89 % vs. 77 %). The optimal stimulation parameters for the two treatments were also different. Compared to SCS, TSGS required a higher frequency but lower pulse width and voltage. CONCLUSION: This study suggests that neuromodulation may be an effective treatment for PHN, but the subtle differences between SCS and TSGS support a more personalized treatment approach.


Asunto(s)
Neuralgia Posherpética , Estimulación de la Médula Espinal , Humanos , Neuralgia Posherpética/terapia , Masculino , Femenino , Anciano , Persona de Mediana Edad , Estudios Retrospectivos , Estimulación de la Médula Espinal/métodos , Resultado del Tratamiento , Dimensión del Dolor , Anciano de 80 o más Años , Terapia por Estimulación Eléctrica/métodos
11.
Expert Rev Med Devices ; 21(8): 741-753, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39044340

RESUMEN

INTRODUCTION: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society. AREAS COVERED: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data. EXPERT OPINION: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.


Asunto(s)
Dolor Crónico , Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Dolor Crónico/terapia , Resultado del Tratamiento
12.
Pain Manag ; 14(5-6): 235-240, 2024 Jun 02.
Artículo en Inglés | MEDLINE | ID: mdl-38973311

RESUMEN

We present a case of deep surgical site infection (SSI) at a spinal cord stimulator (SCS) trial implantation site, resulting from an allergic reaction to an unknown agent. A 38-year-old female with complex regional pain syndrome began an SCS trial, noting 100% pain relief for 5 days. Fluid drainage from the surgical site was reported on POD6 and trial leads were removed the following day. The patient was hospitalized with sepsis. Blood cultures revealed Staphylococcus aureus. MRIs showed skin breakdown and cellulitis of the paraspinal musculature extending into the epidural space. The patient was maintained with antibiotics and rigorous wound care for 9 days and the surgical site infection resolved. The patient proceeded to SCS implantation, and reported good pain relief with the implanted device.


This case report describes the treatment of an infection developed during a spinal cord stimulator (SCS) trial period. SCS are medical devices used to treat pain, they work by applying electrical current to the areas of the spinal cord that cause patients' pain. Before patients get an SCS device implanted, they often undergo a trial period first. During a trial, the stimulator device stays outside the body, and only the wires carrying electricity to the spinal cord are implanted. Typically, SCS trial and implantation procedures are safe and result in effective pain relief. However, infections are a dangerous potential complication that can result from these procedures. In our case, the patient developed an infection during an SCS trial period, likely resulting from an allergic reaction to their surgical dressings. The infection traveled down the wires and nearly reached the spinal cord. Since the infection was quickly identified and managed, devastating complications were avoided. The patient was able to get a permanent SCS after the infection was resolved, and had effective pain relief. Our report emphasizes the importance of using strict infection prevention techniques, and monitoring patients for signs of infection throughout SCS trials.


Asunto(s)
Estimulación de la Médula Espinal , Infección de la Herida Quirúrgica , Humanos , Femenino , Adulto , Estimulación de la Médula Espinal/instrumentación , Estimulación de la Médula Espinal/métodos , Infección de la Herida Quirúrgica/terapia , Infección de la Herida Quirúrgica/etiología , Síndromes de Dolor Regional Complejo/terapia , Síndromes de Dolor Regional Complejo/etiología , Espacio Epidural , Infecciones Estafilocócicas/terapia , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico
13.
Neuromodulation ; 27(5): 908-915, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38971582

RESUMEN

OBJECTIVES: The aim of this economic analysis was to evaluate the cost-effectiveness of differential target multiplexed spinal cord stimulation (DTM-SCS) for treating chronic intractable low back pain, compared with conventional spinal cord stimulation (C-SCS) and conservative medical management (CMM), by updating and expanding the inputs for a previously published cross-industry model. MATERIALS AND METHODS: This model comprised a 12-month decision-tree phase followed by a long-term Markov model. Costs and outcomes were calculated from a UK National Health Service perspective, over a base-case horizon of 15 years and up to a maximum of 40 years. All model inputs were derived from published literature or other deidentified sources and updated to reflect recent clinical trials and costs. Deterministic and one-way sensitivity analyses were performed to calculate costs and quality-adjusted life-years (QALYs) across the 15-year time horizon and to explore the impact of individual parameter variability on the cost-effectiveness results. Probabilistic sensitivity analysis was undertaken to explore the impact of joint parameter uncertainty on the results. RESULTS: DTM-SCS was the most cost-effective option from a payer perspective. Compared with CMM alone, DTM-SCS was associated with an incremental cost-effectiveness ratio (ICER) of £6101 per QALY gained (incremental net benefit [INB] = £21,281). The INB for C-SCS compared with CMM was lower than for DTM-SCS, at £8551. For the comparison of DTM-SCS and C-SCS, an ICER of £897 per QALY gained was calculated, with a 99.5% probability of cost-effectiveness at a £20,000 per QALY threshold. CONCLUSIONS: Among patients with low back pain treated over a 15-year follow-up period, DTM-SCS and C-SCS are cost-effective compared with CMM, from both payer and societal perspectives. DTM-SCS is associated with a lower ICER than that of C-SCS. Wider uptake of DTM-SCS in the UK health care system is warranted to manage chronic low back pain.


Asunto(s)
Dolor de la Región Lumbar , Años de Vida Ajustados por Calidad de Vida , Estimulación de la Médula Espinal , Humanos , Dolor Crónico/terapia , Dolor Crónico/economía , Análisis de Costo-Efectividad , Dolor de la Región Lumbar/terapia , Dolor de la Región Lumbar/economía , Cadenas de Markov , Estimulación de la Médula Espinal/métodos , Estimulación de la Médula Espinal/economía , Reino Unido
14.
Rev Neurol ; 79(4): 99-105, 2024 Aug 16.
Artículo en Español | MEDLINE | ID: mdl-39078029

RESUMEN

INTRODUCTION AND AIMS: The objective of treatment of complex regional pain syndrome is to relieve pain and restore function in the affected limb. The aim of this study is to evaluate spinal cord stimulation as a therapy for patients diagnosed with complex regional pain syndrome, for whom adequate pain control could not be achieved with other previous treatments. PATIENTS AND METHODS: A prospective study was conducted from 2018 to 2020. We included patients diagnosed with complex regional pain syndrome refractory to other treatments or techniques, classified by demographic data. Efficacy, functionality and opioid dependence in each patient were subsequently monitored for one year. RESULTS: Seven of the 13 patients (53.84%) included in the study achieved significant pain relief with spinal cord stimulation. Improvements in pain and functionality were obtained, and both were statistically significant (p < 0.001 and p = 0.003, respectively). Improvement in the Oswestry Disability Index/Neck Disability Index (ODI/NDI) was significantly associated with body mass index (BMI) (p = 0.011) and was lower as BMI increased. CONCLUSIONS: The results suggest that spinal cord stimulation is an effective therapeutic option for patients with CRPS refractory to other treatments. BMI and ODI/NDI also showed a significant correlation.


TITLE: Estimulación medular en el síndrome de dolor regional complejo refractario. Un estudio prospectivo.Introducción y objetivos. En el tratamiento del síndrome de dolor regional complejo se pretende aliviar el dolor y restaurar la función de la extremidad afectada. El objetivo de este estudio es evaluar la estimulación de la médula espinal como terapia para pacientes a quienes se les diagnosticó síndrome de dolor regional complejo, en los que no se ha podido conseguir un control adecuado del dolor con otros tratamientos previos. Pacientes y métodos. Se realizó un estudio prospectivo de 2018 a 2020. Se incluyó a pacientes diagnosticados de síndrome de dolor regional complejo refractario a otros tratamientos o técnicas, clasificados por datos demográficos. Posteriormente, se hizo seguimiento de la eficacia, la funcionalidad y la dependencia de opioides de cada paciente durante un año. Resultados. Siete de los 13 (53,84%) pacientes incluidos en el estudio consiguieron un alivio significativo de su dolor con la estimulación medular. Se obtuvo mejoría del dolor y de la funcionalidad, y ambas fueron estadísticamente significativas (p < 0,001 y p = 0,003, respectivamente). La mejoría en el Oswestry Disability Index/Neck Disability Index (ODI/NDI) se asoció significativamente con el índice de masa corporal (IMC) (p = 0,011) y fue menor cuanto mayor era el IMC. Conclusiones. Los resultados sugieren que la estimulación de la médula espinal es una opción terapéutica eficaz para pacientes con SDRC refractario a otros tratamientos. Además, el IMC y el ODI/NDI mostraron una correlación significativa.


Asunto(s)
Síndromes de Dolor Regional Complejo , Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Estudios Prospectivos , Síndromes de Dolor Regional Complejo/terapia , Femenino , Masculino , Persona de Mediana Edad , Adulto , Resultado del Tratamiento , Anciano
15.
Exp Brain Res ; 242(9): 2229-2239, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39034329

RESUMEN

Transspinal (or transcutaneous spinal cord) stimulation is a promising noninvasive method that may strengthen the intrinsic spinal neural connectivity in neurological disorders. In this study we assessed the effects of cervical transspinal stimulation on the amplitude of leg transspinal evoked potentials (TEPs), and the effects of lumbosacral transspinal stimulation on the amplitude of arm TEPs. Control TEPs were recorded following transspinal stimulation with one cathode electrode placed either on Cervical 3 (21.3 ± 1.7 mA) or Thoracic 10 (23.6 ± 16.5 mA) vertebrae levels. Associated anodes were placed bilaterally on clavicles or iliac crests. Cervical transspinal conditioning stimulation produced short latency inhibition of TEPs recorded from left soleus (ranging from - 6.11 to -3.87% of control TEP at C-T intervals of -50, -25, -20, -15, -10, 15 ms), right semitendinosus (ranging from - 11.1 to -4.55% of control TEP at C-T intervals of -20, -15, 15 ms), and right vastus lateralis (ranging from - 13.3 to -8.44% of control TEP at C-T intervals of -20 and - 15 ms) (p < 0.05). Lumbosacral transspinal conditioning stimulation produced no significant effects on arm TEPs. We conclude that in the resting state, cervical transspinal stimulation affects the net motor output of leg motoneurons under the experimental conditions used in this study. Further investigations are warranted to determine whether this protocol may reactivate local spinal circuitry after stroke or spinal cord injury and may have a significant effect in synchronization of upper and lower limb muscle synergies during rhythmic activities like locomotion or cycling.


Asunto(s)
Brazo , Potenciales Evocados Motores , Pierna , Estimulación de la Médula Espinal , Humanos , Adulto , Masculino , Estimulación de la Médula Espinal/métodos , Femenino , Pierna/fisiología , Brazo/fisiología , Potenciales Evocados Motores/fisiología , Adulto Joven , Región Lumbosacra/fisiología , Músculo Esquelético/fisiología , Electromiografía , Vértebras Cervicales/fisiología , Vías Nerviosas/fisiología
16.
Neuromodulation ; 27(6): 1062-1067, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38958631

RESUMEN

OBJECTIVE: This study aims to elucidate a novel, minimally invasive surgical technique using a biportal endoscope for the implantation of spinal cord stimulation (SCS) paddle leads and to report the preliminary results of its clinical application. MATERIALS AND METHODS: The perioperative data of patients who underwent the biportal endoscopic SCS paddle lead implantation in our department were collected; the surgical procedure was delineated, and the clinical outcomes were assessed. RESULTS: From February 2022 to December 2023, six patients underwent biportal endoscopic SCS paddle lead implantation. The median follow-up time was nine months (range one to three months). The median intraoperative blood loss was 30 mL (range 25-50 mL), and the median operative time was 87.5 minutes (range 75-110 minutes). One patient experienced severe neck pain during the operation, whereas the other five patients experienced no surgical complications. One patient was found to have a slight lead migration three months after surgery, which did not affect the therapeutic effect. The median visual analogue scale (VAS) of the surgical area was 0.5 (range 0-2), 2.5 (range 1-4), and 0.5 (range 0-1) during the operation and one day and one week after the operation, respectively. The median VAS of the six patients' primary disease was 8 (range 7-9) before surgery and 2.5 (range 1-4) at the last postoperative follow-up (pain reduction ≥50%). CONCLUSION: Paddle lead systems for SCS can be implanted successfully using a biportal endoscopic technique.


Asunto(s)
Electrodos Implantados , Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Estimulación de la Médula Espinal/instrumentación , Femenino , Masculino , Persona de Mediana Edad , Anciano , Adulto , Resultado del Tratamiento , Endoscopía/métodos , Estudios de Seguimiento
17.
Neuromodulation ; 27(6): 1020-1025, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38970616

RESUMEN

OBJECTIVES: The aim of this study was to present key technologic and regulatory milestones in spinal cord stimulation (SCS) for managing chronic pain on a narrative timeline with visual representation, relying on original sources to the extent possible. MATERIALS AND METHODS: We identified technical advances in SCS that facilitated and enhanced treatment on the basis of scientific publications and approvals from the United States (US) Food and Drug Administration (FDA). We presented milestones limited to first use in key indications and in the context of new technology validation. We focused primarily on pain management, but other indications (eg, motor disorder in multiple sclerosis) were included when they affected technology development. RESULTS: We developed a comprehensive visual and narrative timeline of SCS technology and US FDA milestones. Since its conception in the 1960s, the science and technology of SCS neuromodulation have continuously evolved. Advances span lead design (from paddle-type to percutaneous, and increased electrode contacts) and stimulator technology (from wireless power to internally powered and rechargeable, with miniaturized components, and programmable multichannel devices), with expanding stimulation program flexibility (such as burst and kilohertz stimulation frequencies), as well as usage features (such as remote programming and magnetic resonance imaging conditional compatibility). CONCLUSIONS: This timeline represents the evolution of SCS technology alongside expanding FDA-approved indications for use.


Asunto(s)
Estimulación de la Médula Espinal , United States Food and Drug Administration , Estimulación de la Médula Espinal/métodos , Estimulación de la Médula Espinal/historia , Estimulación de la Médula Espinal/instrumentación , Estados Unidos , Humanos , Historia del Siglo XX , Dolor Crónico/terapia , Historia del Siglo XXI , Manejo del Dolor/métodos , Manejo del Dolor/historia , Manejo del Dolor/tendencias
18.
Neuromodulation ; 27(6): 1055-1061, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39001726

RESUMEN

BACKGROUND: Spinal cord stimulation (SCS) has been reported to cause substantial pain relief and improved quality of life (QoL) in patients with persistent spinal pain syndrome (PSPS). Despite implantable pulse generator (IPG)-related inconveniences such as pain, shame, and discomfort affecting QoL and patient satisfaction, these are often neglected. Hence, the current study aims to determine the associations between patient satisfaction, IPG-related inconveniences, and preoperative counseling in a homogeneous group of patients with PSPS receiving SCS with IPG implantation in the gluteal or abdominal area. MATERIALS AND METHODS: Retrospective data on sample characteristics were gathered from the EPIC (electronic health record software) digital patient data base. Prospective data on patient satisfaction were obtained with a questionnaire that covered various topics such as shame, pain, disturbances in daily/intense activities, night rest and/or sleep, discomfort caused by clothing, and preoperative counseling. The exact location of the IPG and its scar were determined with photo analysis. Thereafter, the site of IPG placement was classified into separate quadrants within the gluteal and abdominal area. Patient satisfaction was defined as accepting the current location of the IPG without having the wish to undergo revision surgery. RESULTS: In total, 81 participants (50.9 ± 10 years) were included in this analysis, with patient satisfaction observed in 61 patients (75.3%). Among satisfied patients, more extensive preoperative counseling concerning IPG pain and discomfort was reported compared with patients who were not satisfied (p < 0.001). When comparing the two groups, significant differences were found in shame (8/81, 9.9%), IPG site pain (21/81, 25.9%), disturbance of activities (42/81, 51.9%), and clothing-related discomfort (42/81, 51.9%). CONCLUSIONS: On the basis of the current results, shared decision-making and comprehensive preoperative provision of information are recommended to optimize patient satisfaction regarding IPG pain, discomfort, and inconveniences. Although many patients experience these disadvantages despite successful SCS for pain related to PSPS, most of them accept this if they have received adequate preoperative information about expectations.


Asunto(s)
Consejo , Satisfacción del Paciente , Estimulación de la Médula Espinal , Humanos , Estimulación de la Médula Espinal/métodos , Estimulación de la Médula Espinal/instrumentación , Femenino , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Adulto , Anciano , Consejo/métodos , Cuidados Preoperatorios/métodos , Dolor Crónico/terapia , Dolor Crónico/psicología , Calidad de Vida/psicología
20.
PLoS Comput Biol ; 20(7): e1012237, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38950067

RESUMEN

AIM: After spinal cord injuries (SCIs), patients may develop either detrusor-sphincter dyssynergia (DSD) or urinary incontinence, depending on the level of the spinal injury. DSD and incontinence reflect the loss of coordinated neural control among the detrusor muscle, which increases bladder pressure to facilitate urination, and urethral sphincters and pelvic floor muscles, which control the bladder outlet to restrict or permit bladder emptying. Transcutaneous magnetic stimulation (TMS) applied to the spinal cord after SCI reduced DSD and incontinence. We defined, within a mathematical model, the minimum neuronal elements necessary to replicate neurogenic dysfunction of the bladder after a SCI and incorporated into this model the minimum additional neurophysiological features sufficient to replicate the improvements in bladder function associated with lumbar TMS of the spine in patients with SCI. METHODS: We created a computational model of the neural circuit of micturition based on Hodgkin-Huxley equations that replicated normal bladder function. We added interneurons and increased network complexity to reproduce dysfunctional micturition after SCI, and we increased the density and complexity of interactions of both inhibitory and excitatory lumbar spinal interneurons responsive to TMS to provide a more diverse set of spinal responses to intrinsic and extrinsic activation of spinal interneurons that remains after SCI. RESULTS: The model reproduced the re-emergence of a spinal voiding reflex after SCI. When we investigated the effect of monophasic and biphasic TMS at two frequencies applied at or below T10, the model replicated the improved coordination between detrusor and external urethral sphincter activity that has been observed clinically: low-frequency TMS (1 Hz) within the model normalized control of voiding after SCI, whereas high-frequency TMS (30 Hz) enhanced urine storage. CONCLUSION: Neuroplasticity and increased complexity of interactions among lumbar interneurons, beyond what is necessary to simulate normal bladder function, must be present in order to replicate the effects of SCI on control of micturition, and both neuronal and network modifications of lumbar interneurons are essential to understand the mechanisms whereby TMS reduced bladder dysfunction after SCI.


Asunto(s)
Traumatismos de la Médula Espinal , Micción , Traumatismos de la Médula Espinal/fisiopatología , Humanos , Micción/fisiología , Modelos Neurológicos , Estimulación de la Médula Espinal/métodos , Vejiga Urinaria/fisiopatología , Vejiga Urinaria/inervación , Simulación por Computador , Biología Computacional , Médula Espinal/fisiopatología
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