Search Results (51)

Background: Subcutaneous pocket infection is a common morbidity associated with the integration of cardiac implantable electronic devices (CIEDs). A new antibiotic-eluting CIED bioenvelope has been developed as a prophylactic measure to mitigate infection and skin erosion caused by device migration. This study investigated the envelope’s regulatory properties in scar formation and vascularization. Methods: Fibroblasts were seeded on either plastic (n = 6) or small intestine submucosal extracellular matrix (SIS-ECM) (n = 6) for 24 h. The culture media were analyzed for proangiogenic and proinflammatory proteins with multiplex. Sham (n = 8) or SIS-ECM (n = 8) was randomly implanted into the dorsal subcutaneous pocket of mice. The implants were excised on day 7, cultured for 24 h, and the media analyzed. Rabbit models were implanted with either synthetic polymer HDPE (n = 12) or SIS-ECM (n = 11). The treatments were excised at weeks 2, 10, and 26 and then stained for analysis. Results: SIS-ECM significantly increased the fibroblasts’ paracrine release of proangiogenic and proinflammatory factors like VEGF-A (p < 0.05) and IL-6 (p < 0.05) compared with plastic. The murine tissue interacting with SIS-ECM released significantly more angiogenic proteins like VEGF-A (p < 0.05) than the sham. The histology analysis of rabbit subcutaneous tissue revealed a decreasing level of inflammation and fibrosis over time with SIS-ECM. Conclusions: The CIED bioenvelope elicited proangiogenic paracrine signaling and reduced fibrotic response in fibroblasts and animal models. Clinical translation of the CIED bioenvelope as an adjunct to regular prophylactic practice may be warranted in the future. Full article

Objectives: The aim of this study was to evaluate the effectiveness of respiratory muscle training in runners in relation to gender and trainers (PowerBreathe and Threshold). Methods: This study comprised 32 athletes training in middle-distance running at a high sports level. The subjects were divided into groups depending on the applied breathing training (IMT): group IMT on the PowerBreath, group IMT on the Threshold, and the control group labeled sham-IMT. The following tests were performed on each athlete: spirometry, maximal inspiratory pressure, expiratory pressure, and physical performance. Results: A significant increase in the levels of the parameters VO₂/kg, PEF, PI_max, and PE_max, as well as a decrease in lactic acid levels and an increase in lactate threshold in both sexes, were observed as a result of the training on the PowerBreathe device. There were no significant differences in the levels of the parameters VO₂/kg, PEF, PI_max, lactic acid, and lactate threshold in either sex after Threshold training. A significant increase in PE_max was found in the Threshold device training group. Conclusions: Most of the assessed parameters of physical fitness and lung ventilation function, along with the respiratory muscle strength of women and men running middle distances, increased significantly after the use of IMT on PowerBreathe, and these results were maintained in the third stud, in contrast to the use of IMT on Threshold, with which there was no significant improvement. Full article

Background: Treating psychiatric illnesses or influencing mental states with neurofeedback is challenging, likely due to the limited spatial specificity of EEG and the complications arising from the inadequate signal-to-noise ratio reduction of single-trial EEG. Objective: This pilot study aimed to investigate the feasibility of employing a binaural pulse mode-modulation (BPM) device to reduce anxiety by self-regulation. We desired to determine whether anxiety could be significantly reduced or regulated using BPM-type systems. Methods: Sixty adult participants were examined with self-reported anxiety tests (COVID Stress Scale, Generalized Anxiety Disorder 7, Beck Depression Inventory-II), which were completed before treatment, after four weeks, and after 12 weeks post-treatment. This BPM device produced two frequencies which combined to create a binaural pulse through differential auditory tone presentations. The participant calibrated the suitable target tone for optimal treatment efficacy. Each participant adjusted the binaural pulse to enhance the emotional intensity felt when envisioning an experience with comparable emotional significance or while performing a cognitive task while concurrently listening to music. The “treatment” relied on the individual’s regulation of binaural pulses to obtain the desired state. The training concentrated on particular facets of their psychological challenges while listening to an auditory tone, adjusting a knob until the sound amplified the intended emotional state. Another knob was turned to intensify the emotional state associated with distress reduction. Results: On the self-reported measures, the BPM treatment group was significantly better than the sham treatment (control) groups (p < 0.01). These findings indicate that over the four-week intervention period, BPM was similarly effective. On the GAD-7, the significant difference over time was noted before treatment and at the end of treatment for the experimental group, with the average GAD-7 score at the end of treatment being significantly lower (p < 0.01). Conclusions: BPM seems to induce a short-term alteration in self-reported distress levels during therapy. This study’s limitations are examined, and recommendations for future research are provided. Full article

Sleep disruption and deprivation are epidemic problems in the United States, even among those without a clinically diagnosed sleep disorder. Military service members demonstrate an increased risk of insomnia, which doubles after deployment. This study will investigate the ability of a translational device, Teledyne PeakSleep™ (Teledyne Scientific & Imaging, Durham, NC, USA), to reduce sleep onset latency and the time spent awake after sleep onset, with improvement in the subjective benefits of sleep for patients with insomnia by enhancing the brain rhythms within the frontal lobe implicated in slow wave generation. During this crossover trial, patients will use the wearable neurotechnology prototype headband, which delivers < 14 min of frontal short duration repetitive–transcranial electrical stimulation over a 30 min period immediately before trying to fall asleep. Using active stimulation versus a sham paradigm, we will compare actigraphy data, physiological data, and subjective sleep measures against a pre-treatment baseline in the same patient over the course of the 8-week study. If successful, PeakSleep™ could address the final common pathway in insomnia, namely the onset and maintenance of slow-wave sleep (SWS), and accordingly has the potential to enhance sleep onset in a wide range of individuals, most importantly warfighters in whom efficient sleep onset may be critical for operational success. Full article

Background/Objectives: Chronic low back pain (CLBP) is a common condition with limited long-term treatment options. Vagus nerve stimulation (VNS) has shown potential for pain improvement, but its use in CLBP remains underexplored. Our aim was to evaluate the efficacy, feasibility and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing pain and improving functional outcomes in CLBP patients. Methods: Thirty adults with CLBP (VAS ≥ 40/100) participated in this open-label pilot study (NCT05639270). Patients were treated with a taVNS device on the left ear for 30 min daily over a period of 3 months. The primary outcome was a reduction in pain intensity (VAS) at 1 month. Secondary outcomes included pain intensity at 3 months, disability (Oswestry Disability Index, ODI), quality of life (EQ-5D-5L), catastrophizing and psychological distress. In addition, compliance and adverse events were monitored. Results: After 1 month, 27 patients were evaluated. VAS scores decreased significantly by 16.1 (SD = 17.9) mm (p < 0.001) and by 22.5 (25) mm (p < 0.001) after 3 months (24 patients were analyzed). Functional disability improved with an average reduction in ODI of 11.9 (11.1) points (p < 0.001) after 3 months. Other patient-reported outcomes also improved significantly over the 3-month period. Overall, 51.9% of the patients achieved clinically meaningful pain reduction (≥20 mm), and no serious adverse events were reported. Treatment adherence was good, with half of the patients achieving 80% adherence. Conclusions: This pilot study suggests that taVNS is a feasible, safe and potentially effective treatment for CLBP that warrants further investigation in a randomized controlled trial compared to sham stimulation. Full article

Background: Primary dysmenorrhea is a leading cause of chronic cyclic pelvic pain, contributing to a reduced quality of life and sleep disturbances in women. The objective of this study was to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in improving the quality of life, sleep, and overall health perceptions of participants compared to a control group of women with dysmenorrhea over short-term, medium-term, and long-term periods. Methods: A single-blind, controlled clinical trial was conducted, with participants randomly assigned to an experimental group (receiving TTNS) or a control group (receiving sham TTNS). Both groups underwent 12, weekly 30 min sessions using the NeuroTrac™ PelviTone electrostimulation device. Outcomes related to quality of life, sleep deficiency, and overall improvement were evaluated at three time points: short-term (post-treatment), medium-term (1–3 months), and long-term (6 months). Results: Of the 61 participants initially randomized (31 in the experimental group and 30 in the control group), 55 completed the study and were included in the final analysis. A statistically significant improvement was observed in the experimental group in both physical and mental health components, as measured by the SF-36v2^® questionnaire, following 12 weeks of intervention, compared to the control group, persisting 6 months after the intervention. Additionally, statistically significant differences in overall improvement were noted between the two groups, as measured by the PGIC questionnaire at the end of treatment (p = 0.0103) and 6 months post-treatment (p = 0.0432). Conclusions: TTNS appears to be a safe and effective strategy for enhancing quality of life and overall health in women with PD, potentially reducing the reliance on pharmacological treatments or more invasive methods. Full article

Primary dysmenorrhea is considered one of the main causes of pelvic pain during a woman’s childbearing years, resulting in poor quality of life. The objective was to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in painful symptomatology improvement and non-steroidal anti-inflammatory drug (NSAID) intake reduction in women with primary dysmenorrhea (PD) compared with a control group in the short, medium, and long terms. A single-blind, controlled clinical trial was developed. Participants were randomized to the experimental (TTNS) and control group (sham TTNS). Both groups received 12-weekly 30-min sessions with a NeuroTrac^TM PelviTone electrostimulation device. The intensity and severity of pain and non-steroidal anti-inflammatory drug (NSAID) intake were evaluated in the short-term (after treatment), medium-term (1–3 months), and long-term (6 months). A total of 61 participants were randomized, with a split of 31 (experimental group) and 30 (control group), but 55 participants completed the study and were analyzed. Statistically significant differences between both groups in the maximum pain intensity decrease (F = 4.88, p = 0.0043) measured with the visual analogue scale, as well as NSAID intake decrease (F = 4.68, p = 0.011) and days of their ingestion (F = 4.57, p = 0.012) occurred in the short term. Furthermore, significant decreases in the total number of NSAIDs ingested during the cycle (F = 3.82, p = 0.011) and the number of days on which patients ingested NSAIDs (F = 3.59, p = 0.015) in the medium–long term occurred. TTNS could be an effective and safe strategy to reduce pain caused by PD, which could reduce or complement the use of pharmacological techniques and other more invasive methods. Full article

Traumatic spinal cord injury is a major cause of disability for which there are currently no fully effective treatments. Recent studies using epidural electrical stimulation have shown significant advances in motor rehabilitation, even when applied during chronic phases of the disease. The present study aimed to investigate the effectiveness of epidural electric stimulation in the motor recovery of rats with spinal cord injury. Furthermore, we aimed to elucidate the neurophysiological mechanisms underlying motor recovery. First, we improved upon the impact spinal cord injury model to cause severe and permanent motor deficits lasting up to 2 months. Next, we developed and tested an implantable epidural spinal cord stimulator device for rats containing an electrode and an implantable generator. Finally, we evaluated the efficacy of epidural electrical stimulation on motor recovery after spinal cord injury in Wistar rats. A total of 60 animals were divided into the following groups: (i) severe injury with epidural electrical stimulation (injury + stim, n = 15), (ii) severe injury without stimulation (group injury, n = 15), (iii) sham implantation without battery (sham, n = 15), and (iv) a control group, without surgical intervention (control, n = 15). All animals underwent weekly evaluations using the Basso, Beattie, Bresnahan (BBB) locomotor rating scale index, inclined plane, and OpenField test starting one week before the lesion and continuing for eight weeks. After this period, the animals were sacrificed and their spinal cords were explanted and prepared for histological analysis (hematoxylin–eosin) and immunohistochemistry for NeuN, β-III-tubulin, synaptophysin, and Caspase 3. Finally, NeuN-positive neuronal nuclei were quantified through stereology; fluorescence signal intensities for β-tubulin, synaptophyin, and Caspase 3 were quantified using an epifluorescence microscope. The injury + stim group showed significant improvement on the BBB scale compared with the injured group after the 5th week (p < 0.05). Stereological analysis showed a significantly higher average count of neural cells in the injury + stim group in relation to the injury group (1783 ± 2 vs. 897 ± 3, p < 0.001). Additionally, fluorescence signal intensity for synaptophysin was significantly higher in the injury + stim group in relation to the injury group (1294 ± 46 vs. 1198 ± 23, p < 0.01); no statistically significant difference was found in β-III-tubulin signal intensity. Finally, Caspase 3 signal intensity was significantly lower in the stim group (727 ± 123) compared with the injury group (1225 ± 87 p < 0.05), approaching levels observed in the sham and control groups. Our data suggest a regenerative and protective effect of epidural electrical stimulation in rats subjected to impact-induced traumatic spinal cord injury. Full article

Background and Objectives: Compared to other subjects, obese people have inferior trunk muscle endurance and balance. A modern method of neuro-muscular training called whole body vibration (WBV) may improve trunk muscle endurance and balance. This study evaluates the impact of a 4-week WBV program on trunk endurance and balance in obese female students. Materials and Methods: Sixty participants from 18 to 25 years of age and with BMI values ≥ 30 were randomly distributed into two equal groups: Group A (WBV group), who received 4 min of WBV, and Group B (sham WBV group), who received WBV with a turn-off device. The training was conducted two days/week for six weeks. Trunk endurance was evaluated using the Sorensen Test (ST) and Trunk Flexor Endurance Test (TFET). The Single-Leg Test (SLT) was used to assess static balance, while the Biodex Stability System measured dynamic balance. Results: The current study demonstrated no significant differences (p > 0.05) in pre-treatment variables between Groups A and B. Post-treatment, Group A showed a significantly higher duration of the Sorensen test, TFET and SLS than Group B (p < 0.001). Moreover, Group A showed significantly lower dynamic balance (p < 0.001) than Group B. Conclusions: WBV has a short-term effect on trunk endurance and balance in obese female students. WBV can be added to the rehabilitation program for obese subjects with deficits in trunk endurance and balance. Full article

Throughout the isolation process, human islets are subjected to destruction of the islet basement membrane (BM) and reduced oxygen supply. Reconstruction of the BM represents an option to improve islet function and survival post-transplant and may particularly be relevant for islet encapsulation devices and scaffolds. In the present study, we assessed whether Perlecan, used alone or combined with the BM proteins (BMPs) Collagen-IV and Laminin-521, has the ability to protect isolated human islets from hypoxia-induced damage. Islets isolated from the pancreas of seven different organ donors were cultured for 4–5 days at 2% oxygen in plain CMRL (sham-treated controls) or in CMRL supplemented with BMPs used either alone or in combination. Postculture, islets were characterized regarding survival, in vitro function and production of chemokines and reactive oxygen species (ROS). Individually added BMPs significantly doubled islet survival and increased in vitro function. Combining BMPs did not provide a synergistic effect. Among the tested BMPs, Perlecan demonstrated the significantly strongest inhibitory effect on chemokine and ROS production when compared with sham-treatment (p < 0.001). Perlecan may be useful to improve islet survival prior to and after transplantation. Its anti-inflammatory potency should be considered to optimise encapsulation and scaffolds to protect isolated human islets post-transplant. Full article

Knee osteoarthritis (KOA) is a chronic degenerative disease characterized by progressive joint damage leading to significant disability. Although rehabilitative treatment methods for KOA have been widely implemented, the optimal integrated instrumental physical therapy approach remains unclear. Therefore, this study aimed to analyze the effect of Quantum Molecular Resonance (QMR) on pain reduction as the primary outcome and the functional improvement in activity daily living (ADL) as a secondary outcome. The study was designed as a double-blind, randomized, controlled trial in an outpatient setting. Fifty-four (N = 54) patients were enrolled and then randomized into three groups according to a simple randomization list: Group 1 (intensive protocol, N = 22), Group 2 (extensive protocol, N = 21), and a Sham group (N = 11). Patients were evaluated over time with scales assessing pain and function. Treatment was performed with the QMR model electro-medical device, which generates alternating electric currents characterized by high frequency (4–64 MHz). The results showed that QMR had a positive effect with respect to the Sham group in terms of pain and function (p < 0.01), and intensive treatment was more effective than the extensive treatment in terms of “speed of response” to the treatment (p < 0.05). In conclusion, QMR in KOA could be effective in slowing the progression of clinical symptoms and improving patients’ pain and functionality and thus quality of life. Future studies will be necessary to investigate further treatment algorithms and therapeutic associations with rehabilitative exercise. Full article

The study aimed to evaluate the impact of BEMER (Physical Vascular Therapy) on body surface temperature using infrared thermography (IRT) in the distal parts of the forelimbs in Thoroughbreds. The study tested the hypothesis that BEMER therapy leads to an increase in body surface temperature and blood vessel diameter in the distal parts of the forelimbs. The study involved 16 horses, split into 2 groups: active BEMER (n = 8) and sham (n = 8). The active BEMER group had BEMER boots applied to the distal parts of the forelimbs, whereas the sham group had BEMER boots applied without activation of the device. Both groups underwent IRT examination to detect changes in body surface temperature, followed by ultrasonographic examination to assess changes in vein and artery diameter before (BT) and just after (JAT) therapy. The IRT examination was repeated 15 min after BEMER therapy (15AT). There were no significant body surface temperature differences between BT and JAT in any regions of interest (ROIs) in either group. In the active BEMER group, the ROIs did not change significantly at 15AT, compared to the temperatures measured at BT (except for the hooves). At 15AT the temperature of all the ROIs (except the fetlock bone) dropped significantly in the sham group. In the ultrasonographic examination, there was a significant increase in vein and artery diameter in the study group JAT, whereas the sham group had a significant increase only in artery diameter JAT. These results suggest an effect of BEMER on stimulating blood circulation in the distal parts of the forelimbs in clinically healthy horses. IRT did not identify changes in skin surface temperature after BEMER therapy at the distal parts of the forelimbs. Full article

In 1796, American physician Elisha Perkins patented “metallick Tractors” for the treatment of various ailments, particularly those associated with pain. They were subsequently rapidly and widely disseminated in the United States and Great Britain based on testimonials and deceptive marketing tactics. Dissemination was facilitated by endorsements from prominent physicians, politicians, and clergymen; quasi-theoretical, handwaving explanations of efficacy based on Galvani’s then-current experiments; and the procedure’s apparent safety and simplicity. However, blinded placebo-controlled trials in Great Britain using sham devices demonstrated that the therapy was ineffective. In response, in the period from 1798 to 1806, Perkinists unleashed a barrage of disinformation (ad hominem attacks, misleading arguments, unethical propaganda tactics, and poetic and graphic satire) to sway public opinion in favor of the fraudulent therapy and against its critics. The disinformation slowed the abandonment of “tractoration”, but higher-level scientific argumentation ultimately prevailed. The Perkinist disinformation campaign had antecedents with the Mesmerist disinformation campaign in the mid-1780s. Similar propaganda tactics are still widely employed to encourage the purchase and use of disproven or fraudulent therapies, as evidenced by propaganda from adherents of acupuncture in response to negative clinical trials and from supporters of unsafe and ineffective therapies promulgated during COVID-19. Full article

Objective: This was an open-label pilot study to test the feasibility and preliminary efficacy of a wearable digital intervention developed to improve on-task behavior. This was an exploratory study to test for specificity of response on parent- and teacher-reported symptom outcomes in attention and hyperactive/impulsive symptoms, as well as domains of functional impairment, including school behavior and learning and executive function. Method:Participants included 38 children aged 8–12 years with a parent-reported past diagnosis of ADHD. Following baseline ratings from parents (N = 38) and teachers (N = 26), participants wore the device to school for four weeks. Parent and teacher ratings of ADHD symptoms, executive function, and functional impairment were repeated at the end of the four-week intervention period. Results:Statistically significant improvement was seen in the total scores for all parent and nearly all teacher outcomes, with moderate effect size improvements in attention, organization and planning, self-monitoring, school functioning, and teacher-reported academic performance. Conclusions: Preliminary evidence from this open-label pilot study suggests that having a child interact with a wearable device to self-monitor attention is feasible. This exploratory, open-label pilot study found real-world improvement in functional domains, including academic performance. Future research will require a blinded, randomized, controlled trial using an appropriate sham comparator to confirm these findings. Full article

Headache is a leading cause of disability and suffering. One major challenge in developing device treatments is demonstrating their efficacy given devices’ often-high placebo rate. This paper reviews the importance of validating sham devices as part of finalizing the design for larger-scale prospective randomized controlled trials in patients with chronic headache as well as the results of a prospective, single-blind trial to validate two potential sham noninvasive thermal nerve block devices. Study participants were trained to self-administer thermal nerve block treatment using sham devices in an office visit. Two different sham systems with different temperature profiles were assessed. Devices were offered for patients to use daily at-home for one week to assess the durability of sham placebo effects before participants were given active treatment in a second office visit followed by another optional week of self-administered active treatment at-home use. Sham treatments reduced pain scores by an average of 31% from 6.0 ± 2.3 to 4.3 ± 3.3, including two participants who fell asleep during the in-office treatment and woke up with no pain, but whose pain recurred after returning home during at-home use of the sham system. In-office active treatments reduced pain scores by 52% from 6.7 ± 2.1 to 3.3 ± 2.9 with sustained pain relief during optional at-home use. Successful blinding for the study was confirmed with an ideal Bang’s Blinding Index of 0 and an ideal James’ Blinding Index of 1. Both the sham and active treatments were viewed by participants as highly credible, and credibility increased from the beginning to end of sham treatments on average. Full article