Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.

Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARCEX Therapy to improve arm and hand functions in people with chronic SCI. ARCEX Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARCEX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARCEX Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARCEX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 .

[Prolonged spinal and sacral neurostimulation in children with pelvic organ dysfunction: preliminary analysis]. / Dlitel'naya spinal'naya i sakral'naya neirostimulyatsiya u detei pri narusheniyakh funktsii tazovykh organov: predvaritel'nyi analiz.

OBJECTIVE: To evaluate the clinical efficacy of long-term spinal and sacral programmable neurostimulation for pelvic organ dysfunction in patients with myelodysplasia and chronic dysfunction of the bladder and rectum. MATERIAL AND METHODS: A retrospective study included 32 children aged 1-17 years (mean 10.7) with myelodysplasia, pelvic organ dysfunction and ineffective therapy including botulinum therapy and exclusion of tethered spinal cord syndrome. All children underwent comprehensive urodynamic examination with analysis of bladder and residual urine volume, mean flow rate, intravesical pressure and total urine volume, as well as electromyographic examination. Examination was carried out before surgery, after 6, 12 and 36 months. We applied urinary diary, NBSS questionnaire and urodynamic examination data. All patients underwent neurological examinations (neurological status, magnetic resonance imaging of the spinal cord, computed tomography and radiography of the spine, electroneuromyography). The study was conducted at the neurosurgical department of the Republican Children's Clinical Hospital in Ufa between 2014 and 2022. There were 32 implantations of epidural neurostimulators for pelvic organ dysfunctions. RESULTS: Patients used epidural spinal and sacral stimulation up to 6 times a day for 10-15 min turning on the pulse generator. This method significantly increased urinary volume, decreased episodes of urinary leakage and fecal incontinence, residual volume after urination and number of periodic catheterizations compared to baseline data. Sixteen patients were very satisfied, 10 ones were moderately satisfied, and 2 patients were not satisfied with therapy. The number of bladder catheterizations per day decreased by 51.1%. Urine volume significantly increased from 131.5±16.1 to 236±16.7 ml, intravesical pressure decreased from 23.5±4.2 to 18.5±2.1 cm H2O (by 20.3%). CONCLUSION: Chronic epidural spinal and sacral stimulation can improve the quality of life in patients with pelvic organ dysfunction. This technique may be effective for pelvic organ dysfunction caused by myelodysplasia.

Treatment with synchronized radiofrequency and facial muscle stimulation: Histologic analysis of human skin for changes in collagen and elastin fibers.

BACKGROUND: Skin's exposure to intrinsic and extrinsic factors causes age-related changes, leading to a lower amount of dermal collagen and elastin. AIM: This study investigated the effects of a novel facial muscle stimulation technology combined with radiofrequency (RF) heating on dermal collagen and elastin content for the treatment of facial wrinkles and skin laxity. METHODS: The active group subjects (N = 6) received four 20-min facial treatments with simultaneous RF and facial muscle stimulation, once weekly. The control subject (N = 1) was untreated. Skin biopsies obtained at baseline, 1-month and 3-month follow-up were evaluated histologically to determine collagen and elastin fibers content. A group of independent aestheticians evaluated facial skin appearance and wrinkle severity. Patient safety was followed. RESULTS: In the active group, collagen-occupied area reached 11.91 ± 1.80 × 106 µm2 (+25.32%, p < 0.05) and 12.35 ± 1.44 × 105 µm2 (+30.00%, p < 0.05) at 1-month and 3-month follow-up visits. Elastin-occupied area at 1-month and 3-month follow-up was 1.64 ± 0.14 × 105 µm2 (+67.23%, p < 0.05), and 1.99 ± 0.21 × 105 µm2 (+102.80%, p < 0.05). In the control group, there was no significant difference (p > 0.05) in collagen and elastin fibers. Active group wrinkle scores decreased from 5 (moderate, class II) to 3 (mild, class I). All subjects, except the control, improved in appearance posttreatment. No adverse events or side effects occurred. CONCLUSION: Decreased dermal collagen and elastin levels contributes to a gradual decline in skin elasticity, leading to facial wrinkles and unfirm skin. Study results showed noticeable improvement in facial appearance and increased dermal collagen and elastin content subsequent to simultaneous, noninvasive RF, and facial muscle stimulation treatments.

Sacral neuromodulation for constipation and fecal incontinence in children and adolescents - study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique.

BACKGROUND: A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial. METHODS: A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM). We include patients with constipation according to the ROME IV criteria and refractory to conventional options. Patients with functional constipation and Hirschsprung's disease are able to participate. Participants are allocated in a 1:1 ratio to either SNM or ENM group. Clinical data and quality of life is evaluated in regular check-ups. Neuromodulation is applied continuously for 3 months (end point of the study) with follow-up-points at 6 and 12 months. Findings are analyzed statistically considering a 5% significance level (p ≤ 0.05). Outcome variables are defined as change in (1) episodes of abdominal pain, (2) episodes of FI, (3) defecation frequency, (4) stool consistency. Improvement of proprioception, influence on urinary incontinence, quality of life and safety of treatment are assessed as secondary outcome variables. We expect a relevant improvement in both study groups. DISCUSSION: This is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM). TRIAL REGISTRATION: The study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021).

20 years of neuromuscular electrical stimulation in COPD.

Although a lung disease, COPD is also associated with extrapulmonary manifestations including, among others, limb muscle dysfunction. Limb muscle dysfunction is a key systemic consequence of COPD that impacts patients' physical activity, exercise tolerance, quality of life and survival. Deconditioning is the main mechanism underlying the development of limb muscle dysfunction in COPD, which can be partially improved with exercise. However, some patients may not be able to tolerate exercise because of incapacitating breathlessness or unwillingness to undertake whole-body exercise. Alternative training modalities that do not give rise to dyspnoea, such as neuromuscular electrical stimulation (NMES), are urged. Over the past 20 years, NMES in COPD has presented conflicting conclusions in meta-analysis. In this review, we try to understand the reason for this result by analysing possible biases and factors that brought conflicting conclusions. We discuss the population (the intervention group, but also the control group), the outcome measures, the frequency of stimulation, the rehabilitation protocol (i.e. NMES alone versus standard care/rehabilitation or NMES plus conventional exercise training versus conventional exercise training alone or NMES versus sham treatment) and the trial design. The main reason for this discrepancy is the lack of dedicated guidelines for NMES. Further research is urged to determine the optimal parameters for an NMES programme. Despite this, NMES appears to be an effective means of enhancing quadriceps strength and exercise capacity in COPD with the potential to break the vicious circle induced by the disease and COPD patients' lifestyle.

Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.

AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.

Analysis by sex of safety and effectiveness of transvenous phrenic nerve stimulation.

PURPOSE: Little is known about sex differences in the treatment of central sleep apnea (CSA). Our post hoc analysis of the remede System Pivotal Trial aimed to determine sex-specific differences in the safety and effectiveness of treating moderate to severe CSA in adults with transvenous phrenic nerve stimulation (TPNS). METHODS: Men and women enrolled in the remede System Pivotal Trial were included in this post hoc analysis of the effect of TPNS on polysomnographic measures, Epworth Sleepiness Scale, and patient global assessment for quality of life. RESULTS: Women (n = 16) experienced improvement in CSA metrics that were comparable to the benefits experienced by men (n = 135), with central apneas being practically eliminated post TPNS. Women experienced improvement in sleep quality and architecture that was comparable to men post TPNS. While women had lower baseline apnea hypopnea index than men, their quality of life was worse at baseline. Additionally, women reported a 25-percentage point greater improvement in quality of life compared to men after 12 months of TPNS therapy. TPNS was found to be safe in women, with no related serious adverse events through 12 months post-implant, while men had a low rate of 10%. CONCLUSION: Although women had less prevalent and less severe CSA than men, they were more likely to report reduced quality of life. Transvenous phrenic nerve stimulation may be a safe and effective tool in the treatment of moderate to severe CSA in women. Larger studies of women with CSA are needed to confirm our findings. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01816776; March 22, 2013.

Do patients experience decisional regret after sacral neuromodulation for refractory overactive bladder?

OBJECTIVE: Success following urological procedures is traditionally defined through objective endpoints. This approach may not capture the impact on patient satisfaction. There is a paucity of literature evaluating patient-centered metrics such as satisfaction and decisional regret in the field of urology. This study investigates long-term satisfaction and decisional regret amongst patients who underwent sacral neuromodulation (SNM) for the treatment of refractory overactive bladder (OAB). MATERIALS AND METHODS: This study retrospectively reviewed patients who underwent SNM for refractory OAB from 2015 to 2022 at a single institution serving an ethnically diverse and underrepresented community. Demographic data were collected through chart review and surveys conducted via telephone calls. Patient satisfaction and decisional regret was measured with the validated modified SDS-DRS scale (satisfaction with decision scale-decision regret scale). Descriptive statistics, Wilcoxan rank sum, and median regression analyses were performed using STATA 15.0 with p < 0.05 as significant. RESULTS: Out of 191 patients who underwent SNM, 63 were unreachable (wrong number in chart, number not in service, patient did not answer, deceased). Eighty-nine out of 128 patients reached agreed to participate (70% response rate). The mean time since surgery was 37.3 ±25.2 months. The median satisfaction with decision score was 4.0 (IQR: 3.7-4.7) with a score of 1 correlating with low satisfaction and a score of 5 correlating with high satisfaction. The median decisional regret score was 2.0 (IQR: 1.2-2.9) with a score of 1 correlating with low decisional regret and a score of 5 correlating with strong decisional regret. Ten patients reported complications after surgery, which was significantly associated with lower SDS and higher DRS scores (p < 0.01), and persisted after adjusting for age, body mass index, sex, and comorbidities (SDS ß coef: -0.84, 95% CI: -1.5 to 0.15, p = 0.02; DRS ß coef: 1.48, 95% CI: 0.55-2.41, p < 0.01). CONCLUSIONS: Patients who underwent SNM for refractory OAB overall had low regret and high satisfaction with their decision at an average 3 years of follow-up. As expected, those who developed postoperative complications had worse scores. The inclusion of patient-centric outcomes is imperative when determining the success of a surgical procedure and is useful for shared decision-making when advancing to third-line therapy for OAB. Longer-term follow-up is necessary to assess durability of high satisfaction and low regret over time.

Treatment of a floppy epiglottis with upper airway stimulation therapy.

PURPOSE: To evaluate the efficacy of upper airway stimulation therapy in patients with a floppy epiglottis who have experienced continuous positive airway pressure failure or intolerance. METHODS: A retrospective single-center cohort study was conducted. Patients who received an Inspire Upper Airway Stimulation system and had a 1-year follow-up were included. Baseline and one-year in-laboratory polysomnography examinations were performed. Patient characteristics, Epworth Sleepiness Scale scores and upper airway stimulation device settings were collected. RESULTS: A total of 75 patients were included, of whom 10 had a floppy epiglottis. Patients with a floppy epiglottis had a significant therapeutic response to upper airway stimulation therapy, similar to patients without a floppy epiglottis. According to the Sher's success criteria, 90% of patients with a floppy epiglottis and 68% of patients without a floppy epiglottis were responders to therapy (p = 0.149). In the floppy epiglottis group, the apnea-hypopnea index decreased from 35.1 ± 5.5 events/hour to 11.2 ± 11.3 events/hour (95% CI (15.0, 32.9), p < 0.001), similarly in the non-floppy epiglottis group, the decline was from 36.4 ± 8.3 events/hour to 14.4 ± 9.5 events/hour (95% CI (18.6, 25.2), p < 0.001, between groups p = 0.659). Comparable reductions were observed for the other respiratory parameters. CONCLUSION: Treatment of patients with obstructive sleep apnea and a floppy epiglottis can be challenging. Continuous positive airway pressure may aggravate the epiglottis collapse. Upper airway stimulation therapy can be considered an effective alternative treatment option for patients with a floppy epiglottis who have encountered either continuous positive airway pressure failure or intolerance.

Sacral Neuromodulation Versus Conservative Treatment for Refractory Idiopathic Slow-transit Constipation: The Randomized Clinical No.2-Trial.

OBJECTIVE: Assess the effectiveness of sacral neuromodulation (SNM) versus personalized conservative treatment (PCT) in patients with refractory idiopathic slow-transit constipation (STC). BACKGROUND: Evidence on SNM for idiopathic STC is conflicting and of suboptimal methodological quality. METHODS: The No.2-Trial was a multicenter, open-label, pragmatic, randomized trial performed in 2 Dutch hospitals. Sixty-seven patients with idiopathic STC, a defecation frequency <3 per week and refractory (ie, unresponsive) to maximal conservative (nonoperative) treatment were included. Exclusion criteria included outlet obstruction, rectal prolapse, and previous colon surgery. Patients were randomized (3:2) to SNM (n=41) or PCT (n=26) with randomization minimization between February 21, 2017 and March 12, 2020. In SNM patients, an implantable pulse generator was implanted after a successful 4-week test stimulation. PCT patients received conservative treatment such as laxatives or retrograde colonic irrigation. The primary outcome was treatment success (defined as average defecation frequency ≥3 per week) after 6 months. Secondary outcomes included constipation severity, fatigue, quality of life, and adverse events. Analysis was according to intention-to-treat. RESULTS: After 6 months, 22 (53.7%) patients were successfully treated with SNM versus 1 (3.8%) patient with PCT (odds ratio 36.4, 95% CI 3.4-387.5, P =0.003). At 6 months, SNM patients reported lower constipation severity and fatigue scores ( P <0.001) and improved quality of life compared with PCT ( P <0.001). Eight serious adverse events (6 SNM, 2 PCT) and 78 adverse events (68 SNM, 10 PCT) were reported. CONCLUSIONS: SNM is a promising surgical treatment option in a homogeneous group of adults and adolescents with refractory idiopathic STC. No.2-Trial registered at ClinicalTrials.gov NCT02961582.

Challenges and adverse events in pediatric hypoglossal nerve stimulation.

INTRODUCTION: Hypoglossal nerve stimulation was recently FDA approved for use in children with Down Syndrome and persistent obstructive sleep apnea. Although there is a robust experience in hypoglossal nerve stimulation in adults, we observed several challenges that are unique to providing this therapy to a complex pediatric population with a high rate of sensory processing disorders. We sought to review the adverse events and challenges to inform clinicians as hypoglossal nerve stimulation becomes a more accessible option for this complex population. METHODS: Retrospective case series of children with Down Syndrome and persistent OSA who underwent hypoglossal nerve stimulation. Inclusion and exclusion criteria included Down Syndrome, age 10-22 years, persistent severe OSA after adenotonsillectomy (AHI>10 with <25 % central or mixed events), inability to tolerate positive airway pressure, and absence of concentric palatal collapse on sleep endoscopy. Patients were identified and their charts were reviewed. Adverse events and their subsequent management were recorded. The major outcome variable was the total number of adverse events. RESULTS: A total of 53 patients underwent implantation of a hypoglossal nerve stimulator; 35 (66 %) patients were male and the average age at implantation was 15.1 years (standard deviation 3.0y). A total of 30 adverse events were noted, including 17 nonserious and 13 serious. The most common nonserious complications included temporary tongue discomfort, rash at the surgical site, and cellulitis. Serious complications included readmission (for cellulitis, pain, and device extrusion), reoperation (most commonly for battery depletion) and pressure ulcer formation. CONCLUSION: Hypoglossal nerve stimulation provides a much-needed therapy for children with DS and persistent OSA after adenotonsillectomy. Although there is a robust experience in providing this treatment to adults, many considerations must be made when adapting this technology to a pediatric population with a high rate of sensory processing disorders.

Case report: Dorsal root ganglion stimulator lead fracture.

BACKGROUND: One of the unique advances in neuromodulation for chronic pain has been spinal cord stimulators (SCS) and dorsal root ganglion stimulators (DRG-S). These devices have aided in conditions such as neuropathic pain, complex regional pain syndromes, failed back surgery, and peripheral neuropathies. With these benefits, however, complications from implantable stimulators have included lead fractures and migration. The authors reviewed a lead migration, kinking, and subsequent fracture event involving a patient with complex regional pain syndrome (CRPS) II, who was treated with a DRG-S. CASE PRESENTATION: The case report follows this patient, from their past medical history to assessment of appropriate qualifications for neuromodulation, to successful surgical placement, to follow-up care. The authors further monitored assessment of inefficacy of pain relief, and identification of lead migration and kinking through imaging. In the process of removal, due to lead stress, lead fracturing occurred. After lead removal, the leads were fully replaced, and the patient was followed up and experienced improved pain relief. CONCLUSION: The case report assesses probable mechanisms of lead fracture and considerations for physicians for future assessment and triage of neuromodulation efficacy.

Acupuncture treatment of acute urinary retention caused by varicella-zoster virus through by combining the mechanism of sacral neuromodulation: A rare case report.

RATIONALE: Urinary dysfunction triggered by varicella-zoster virus (VZV) attacking the nervous system seriously affects the quality of life of patients and may even cause irreversible damage to the urinary system. This a 62-year-old man with acute urinary retention triggered by VZV, who was cured after acupuncture treatment. The rational application of acupuncture therapy to promote the recovery of bladder contraction function can effectively relieve the symptoms of dysuria, shorten the course of the disease. PATIENT CONCERNS: Symptoms included dysuria and distension of the bladder area secondary to postherpetic herpes zoster, with significant pressure and pain in his lower abdomen, accompanied by cutaneous herpes distributed over the sacral region. DIAGNOSES: The case was diagnosed as acute urinary retention (Neurogenic Bladder). Ancillary tests include urodynamic examination, Doppler ultrasound, urodynamic tests are the preferred diagnostic method and suggest: no contraction of the detrusor muscle is seen during voiding, and voiding occurs in an The absence of abdominal pressure-assisted micturition and repeated attempts to pass urine suggests detrusor weakness; residual urine suggests a severe bladder emptying disorder. Doppler ultrasound suggested overfilling of the bladder, and 1153 mL of residual urine was seen in the bladder after voiding. INTERVENTIONS: The patient developed sacral herpes and dysuria and was treated with oral antiviral drugs on the 12th day of illness. But his urinary difficulty did not improve but gradually worsened, resulting in acute urinary retention, and he then turned to the acupuncture treatment, innovative approach combined the mechanism of action of sacral neuromodulation with traditional Chinese medicine theory. OUTCOMES: The duration of acupuncture treatment totaled 12 weeks; he was able to urinate on her own and her symptoms completely disappeared. No other adverse and unintended events occurred during treatment. LESSONS: This study demonstrates that acupuncture is safe and effective in the treatment of acute urinary retention caused by VZV, which is worth recommending as a conservative treatment. Moreover, we found that the early intervention and full-term treatment with acupuncture is particularly important, provided that the right key acupoints are selected.

The effects of neuromuscular electrical stimulation on hospitalised adults: systematic review and meta-analysis of randomised controlled trials.

INTRODUCTION: Neuromuscular electrical stimulation (NMES) is a treatment to prevent or reverse acquired disability in hospitalised adults. We conducted a systematic review and meta-analysis of its effectiveness. METHOD: We searched MEDLINE, EMBASE, Cumulative Index to Nursing & Allied Health (CINAHL) and the Cochrane library. Inclusion criteria: randomised controlled trials of hospitalised adult patients comparing NMES to control or usual care. The primary outcome was muscle strength. Secondary outcomes were muscle size, function, hospital length of stay, molecular and cellular biomarkers, and adverse effects. We assessed risk of bias using the Cochrane risk-of-bias tool. We used Review Manager (RevMan) software for data extraction, critical appraisal and synthesis. We assessed certainty using the Grading of Recommendations Assessment, Development and Evaluation tool. RESULTS: A total of 42 papers were included involving 1,452 participants. Most studies had unclear or high risk of bias. NMES had a small effect on muscle strength (moderate certainty) (standardised mean difference (SMD) = 0.33; P < 0.00001), a moderate effect on muscle size (moderate certainty) (SMD = 0.66; P < 0.005), a small effect on walking performance (moderate certainty) (SMD = 0.48; P < 0.0001) and a small effect on functional mobility (low certainty) (SMD = 0.31; P < 0.05). There was a small and non-significant effect on health-related quality of life (very low certainty) (SMD = 0.35; P > 0.05). In total, 9% of participants reported undesirable experiences. The effects of NMES on length of hospital stay, and molecular and cellular biomarkers were unclear. CONCLUSIONS: NMES is a promising intervention component that might help to reduce or prevent hospital-acquired disability.

Electrical stimulation therapy for pain and related symptoms in multiple sclerosis: A systematic review and meta-analysis.

BACKGROUND: The effectiveness of electrical stimulation therapy (EST) for pain, depression, fatigue, disability, and quality of life in multiple sclerosis (MS) remains uncertain. This study aims to analyze and discuss the efficacy of various EST treatments in alleviating pain among MS patients. METHODS: The primary search was conducted using PubMed, Web of Science, Cochrane Library, Embase, and the Cumulative Index of Nursing and Allied Health Literature databases until September 25, 2023. Randomized controlled trials (RCTs) including patients with MS pain receiving EST compared with other therapies were included. Pain intensity, quality of life, and neuropsychiatric symptoms were reported. The mean difference (MD) with 95 % confidence intervals (CIs) was estimated separately for outcomes to understand the mean effect size. RESULTS: Ten RCTs containing 315 participants were included. The pooled data from 8 trials including 267 participants showed that the EST was superior in alleviating pain (MD = -1.75, 95 % CI -2.85--0.64, P = 0.002, I2=73 %) evaluated by the visual analog scale. In subgroup analysis, medium-term EST treatment showed the highest effect size compared to short-term and long-term treatment (MDmedium-term = -2.17, 95 % CI -3.51--0.84, P = 0.001, I2 = 0 %). However, no significant differences were found in terms of pain-related quality of life, depression, fatigue, and pain-related disability. No adverse events related to EST were reported. A high risk of bias was identified in three of the ten included studies. CONCLUSIONS: EST is effective and safe for alleviating pain in MS, but it should be noted that limited sample sizes and methodological issues were present in the included studies. More robust assessment criteria and high-quality RCTs are required for patients with MS. TRIAL REGISTRATION: CRD42023406787. (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=406787).

A prospective open label 2-8 year extension of the randomised controlled ICON trial on the long-term efficacy and safety of occipital nerve stimulation in medically intractable chronic cluster headache.

BACKGROUND: We demonstrated in the randomised controlled ICON study that 48-week treatment of medically intractable chronic cluster headache (MICCH) with occipital nerve stimulation (ONS) is safe and effective. In L-ICON we prospectively evaluate its long-term effectiveness and safety. METHODS: ICON participants were enrolled in L-ICON immediately after completing ICON. Therefore, earlier ICON participants could be followed longer than later ones. L-ICON inclusion was stopped after the last ICON participant was enrolled in L-ICON and followed for ≥2 years by completing six-monthly questionnaires on attack frequency, side effects, subjective improvement and whether they would recommend ONS to others. Primary outcome was the change in mean weekly attack frequency 2 years after completion of the ICON study compared to baseline. Missing values for log-transformed attack-frequency were imputed for up to 5 years of follow-up. Descriptive analyses are presented as (pooled) geometric or arithmetic means and 95% confidence intervals. FINDINGS: Of 103 eligible participants, 88 (85%) gave informed consent and 73 (83%) were followed for ≥2 year, 61 (69%) ≥ 3 year, 33 (38%) ≥ 5 years and 3 (3%) ≥ 8.5 years. Mean (±SD) follow-up was 4.2 ± 2.2 years for a total of 370 person years (84% of potentially 442 years). The pooled geometric mean (95% CI) weekly attack frequency remained considerably lower after one (4.2; 2.8-6.3), two (5.1; 3.5-7.6) and five years (4.1; 3.0-5.5) compared to baseline (16.2; 14.4-18.3). Of the 49/88 (56%) ICON ≥50% responders, 35/49 (71%) retained this response and 15/39 (38%) ICON non-responders still became a ≥50% responder for at least half the follow-up period. Most participants (69/88; 78% [0.68-0.86]) reported a subjective improvement from baseline at last follow-up and 70/88 (81% [0.70-0.87]) would recommend ONS to others. Hardware-related surgery was required in 44/88 (50%) participants in 112/122 (92%) events (0.35 person-year-1 [0.28-0.41]). We didn't find predictive factors for effectiveness. INTERPRETATION: ONS is a safe, well-tolerated and long-term effective treatment for MICCH. FUNDING: The Netherlands Organisation for Scientific Research, the Dutch Ministry of Health, the NutsOhra Foundation from the Dutch Health Insurance Companies, and Medtronic.

Rhabdomyolysis in a young woman after whole-body electromyostimulation training.

This is a case report of a hospitalised 31-year-old female with rhabdomyolysis following a single 20-minute training session wearing a whole-body electromyostimulation (WB-EMS) suit. The patient presented with severe muscle pain, dark-coloured urine, and among others elevated levels of plasma creatine kinase and myoglobin. This case report demonstrate that unaccustomed WB-EMS training may be harmful. Therefore, healthcare professionals as well as those using and operating the WB-EMS applications should be aware of the potential adverse events to the equipment, e.g. severe rhabdomyolysis.

Electromagnetic radiation therapy for Parkinson's disease tremor reduction- systematic reviews and Bayesian meta-analyses for comparing the effectiveness of electric, magnetic and light stimulation methods.

PURPOSE: Tremor is one of the key characteristics of Parkinson's disease (PD), leading to physical disabilities and often showing limited responses to pharmacological treatments. To suppress tremors in PD patients, several types of non-invasive and non-pharmacological methods have been proposed so far. In the current systematic review, three electromagnetic-based radiation strategies including electrical stimulation, magnetic stimulation, and light stimulation methods were reviewed and compared. METHODS: Major databases were searched to retrieve eligible studies. For the meta-analysis, a random-effect Bayesian framework was used. Also, heterogeneity between studies was assessed using I2 statistic, prediction interval, and tau2. Publication bias was assessed using funnel plot, and the effectiveness of methods for reducing tremor was compared using network Bayesian meta-analysis. RESULTS AND CONCLUSION: Thirty-one studies were found for qualitative analysis, and 16 studies were found for quantitative synthesis. Based on the suppression ratio, methods can be ordered as electrical stimulation, light therapy, and magnetic stimulation. Furthermore, the results showed that electrical and magnetic stimulation were more effective for tremor suppression at early stages of PD, while light therapy was found to be more effective during the later stages of PD.

Baroreflex activation therapy in patients with heart failure with reduced ejection fraction: a single-centre experience.

AIMS: Heart failure with reduced ejection fraction (HFrEF) is associated with excessive sympathetic and impaired parasympathetic activity. The Barostim Neo™ device is used for electronical baroreflex activation therapy (BAT) to counteract autonomic nervous system dysbalance. Randomized trials have shown that BAT improves walking distance and reduces N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels at least in patients with only moderate elevation at baseline. Its impact on the risk of heart failure hospitalization (HFH) and death is not yet established, and experience in clinical routine is limited. METHODS AND RESULTS: We report on patient characteristics and clinical outcome in a retrospective, non-randomized single-centre registry of BAT in HFrEF. Patients in the New York Heart Association (NYHA) Classes III and IV with a left ventricular ejection fraction (LVEF) <35% despite guideline-directed medical therapy were eligible. Symptom burden, echocardiography, and laboratory testing were assessed at baseline and after 12 months. Clinical events of HFH and death were recorded at routine clinical follow-up. Data are shown as number (%) or median (inter-quartile range). Between 2014 and 2020, 30 patients were treated with BAT. Median age was 67 (63-77) years, and 27 patients (90%) were male. Most patients (83%) had previous HFH. Device implantation was successful in all patients. At 12 months, six patients had died and three were alive but did not attend follow-up. NYHA class was III/IV in 26 (87%)/4 (13%) patients at baseline, improved in 19 patients, and remained unchanged in 5 patients (P < 0.001). LVEF improved from 25.5 (20.0-30.5) % at baseline to 30.0 (25.0-36.0) % at 12 months (P = 0.014). Left ventricular end-diastolic diameter remained unchanged. A numerical decrease in NT-proBNP [3165 (880-8085) vs. 1001 (599-3820) pg/mL] was not significant (P = 0.526). Median follow-up for clinical events was 16 (10-33) months. Mortality at 1 (n = 6, 20%) and 3 years (n = 10, 33%) was as expected by the Meta-Analysis Global Group in Chronic Heart Failure risk score. Despite BAT, event rate was high in patients with NYHA Class IV, NT-proBNP levels >1600 pg/mL, or estimated glomerular filtration rate (eGFR) <30 mL/min at baseline. NYHA class and eGFR were independent predictors of mortality. CONCLUSIONS: Patients with HFrEF who are selected for BAT are in a stage of worsening or even advanced heart failure. BAT appears to be safe and improves clinical symptoms and-to a modest degree-left ventricular function. The risk of death remains high in advanced disease stages. Patient selection seems to be crucial, and the impact of BAT in earlier disease stages needs to be established.

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.