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Preliminary evidence suggests transcranial direct current stimulation (tDCS) has antidepressant efficacy. To further investigate the efficacy of tDCS in a double-blind, sham-controlled trial (registered at www.clinicaltrials.gov: NCT00763230). Sixty-four participants with current depression received active or sham anodal tDCS to the left prefrontal cortex (2 mA, 15 sessions over 3 weeks), followed by a 3-week open-label active treatment phase. Mood and neuropsychological effects were assessed. There was significantly greater improvement in mood after active than after sham treatment (P<0.05), although no difference in responder rates (13% in both groups). Attention and working memory improved after a single session of active but not sham tDCS (P<0.05). There was no decline in neuropsychological functioning after 3-6 weeks of active stimulation. One participant with bipolar disorder became hypomanic after active tDCS. Findings confirm earlier reports of the antidepressant efficacy and safety of tDCS. Vigilance for mood switching is advised when administering tDCS to individuals with bipolar disorder.

Many double-blind clinical trials of transcranial direct current stimulation (tDCS) use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised) at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ) 0.28, 95% confidence interval (CI) 0.09 to 0.47 p=0.005) and the second session (κ=0.77, 95%CI 0.64 to 0.90), p=<0.001) indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ=0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ=0.677, 95%CI 0.534 to 0.82) indicating inadequate assessor blinding. Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.

Background The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. Methods Participants with body mass index (BMI) 40 to 45 kg/m 2 , or 35 to 40 kg/m 2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. Results At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months ( n  = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. Conclusions vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. Trial Registration https://clinicaltrials.gov/ct2/show/NCT01327976

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 ARC EX Therapy to improve arm and hand functions in people with chronic SCI. ARC EX 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 ARC EX Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARC EX 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 ARC EX Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 . Externally applied electrical stimulation over the cervical spinal cord improves arm and hand functions in people with chronic tetraplegia due to spinal cord injury.

Introduction Post stroke elbow spasticity (PSES) affects over a third of individuals following stroke and negatively impacts on functional recovery, comfort and quality of life. Drug therapies have limited efficacy and unwanted side effects, botulinum toxin, although effective, is costly, and conventional electrical stimulation therapies are limited long term by habituation. We aim to investigate the efficacy of Sheffield Adaptive Patterned Electrical Stimulation (SHAPES), that delivers temporally and spatially varying pattern of electrical stimulation, against transcutaneous electrical stimulation (TENS) and standard care at reducing PSES. Methods and design Overall, 297 people with PSES will be randomised (1:1:1) to one of 3 arms: Standard care (no electrical stimulation), TENS (conventional patterned electrical stimulation) or SHAPES (adaptive patterned electrical stimulation). Both SHAPES and TENS are delivered using a specially designed electrical stimulation sleeve used for 60 min each day for 6-weeks. Outcome measures are completed at baseline, end of treatment (EOT 6 weeks) and then 6-weeks, 12-weeks and 24-weeks after the end of treatment. Efficacy will be determined based on the proportion of participants experiencing meaningful improvement (18%) in the 7-day Numerical Rating Scale (NRS-S) for PSES, compared between both intervention arms and standard care, and between the two intervention groups. Measures of arm motor function (Action Research Arm Test, MRC scale), and quality of life (SQoL-6D, EQ-5D) will also be measured along with a parallel health economic evaluation. Discussion The results of the SHAPES trial will inform management of elbow spasticity after stroke. The SHAPES intervention is a low cost, self-administered intervention for the management of spasticity that can be used repeatedly, and if found to be more effective than TENS or control has the potential to be widely implemented in the UK NHS healthcare setting. Furthermore, despite the wide use of TENS in the management of spasticity, this study will provide critically required evidence regarding its efficacy. The trial has been registered with the ISRCTN registry (ISRCTN26060261).

Delivering short trains of electric pulses to the muscles and nerves can elicit action potentials resulting in muscle contractions. When the stimulations are sequenced to generate functional movements, such as grasping or walking, the application is referred to as functional electrical stimulation (FES). Implications of the motor and sensory recruitment of muscles using FES go beyond simple contraction of muscles. Evidence suggests that FES can induce short- and long-term neurophysiological changes in the central nervous system by varying the stimulation parameters and delivery methods. By taking advantage of this, FES has been used to restore voluntary movement in individuals with neurological injuries with a technique called FES therapy (FEST). However, long-lasting cortical re-organization (neuroplasticity) depends on the ability to synchronize the descending (voluntary) commands and the successful execution of the intended task using a FES. Brain-computer interface (BCI) technologies offer a way to synchronize cortical commands and movements generated by FES, which can be advantageous for inducing neuroplasticity. Therefore, the aim of this review paper is to discuss the neurophysiological mechanisms of electrical stimulation of muscles and nerves and how BCI-controlled FES can be used in rehabilitation to improve motor function.

In this randomized trial of deep-brain stimulation targeted to either the globus pallidus interna or the subthalamic nucleus in patients with advanced Parkinson's disease, the patients assigned to pallidal stimulation and those assigned to subthalamic stimulation had a similar improvement in motor function. In this trial of deep-brain stimulation targeted to either the globus pallidus interna or the subthalamic nucleus in patients with advanced Parkinson's disease, the patients assigned to pallidal stimulation and those assigned to subthalamic stimulation had a similar improvement in motor function. Randomized studies have shown that treatment with deep-brain stimulation, which involves the surgical implantation of a device that sends electrical impulses to specific parts of the brain, is superior to medical therapy for improving motor function and quality of life for patients with advanced Parkinson's disease. 1 , 2 The globus pallidus interna and the subthalamic nucleus are both accepted targets for deep-brain stimulation. The subthalamic nucleus is used more commonly as the target, despite the lack of evidence showing that neurostimulation of this target provides a better outcome. Our multicenter, randomized, blinded trial, called the Veterans Affairs Cooperative Studies Program (CSP) . . .

The efficacy and comfort of neuromuscular electrical stimulation (NMES) largely depend on the type of electrodes used. Traditional self-adhesive hydrogel electrodes, while effective, pose limitations in terms of wearability, skin compatibility, and reusability. This randomized crossover trial investigates the performance of a specific textile electrode integrated into garments for NMES of lower extremities, focusing on their potential rehabilitative applications for patients with neurological disorders such as stroke, multiple sclerosis (MS), and spinal cord injury (SCI). In this randomized crossover design, ten healthy subjects participated in the study. Each subject performed isometric knee extension exercises using both textile and hydrogel electrodes in random order. The electrodes were compared in terms of comfort, temporal consistency, stimulation efficiency, and electrical impedance under isometric conditions. Our findings revealed no significant difference between the two types of electrodes across all evaluated parameters. Textile electrodes, used after applying moisturizing lotion to enhance the electrode-skin interface, demonstrated comparable levels of comfort, consistency, and efficiency to hydrogel electrodes. The equivalence of textile and hydrogel electrodes, coupled with the advantages of washability and reusability, positions textile electrodes as a promising alternative for NMES applications, particularly in rehabilitation settings.

Our experiences can blind us. Once we have learned to solve problems by one method, we often have difficulties in generating solutions involving a different kind of insight. Yet there is evidence that people with brain lesions are sometimes more resistant to this so-called mental set effect. This inspired us to investigate whether the mental set effect can be reduced by non-invasive brain stimulation. 60 healthy right-handed participants were asked to take an insight problem solving task while receiving transcranial direct current stimulation (tDCS) to the anterior temporal lobes (ATL). Only 20% of participants solved an insight problem with sham stimulation (control), whereas 3 times as many participants did so (p = 0.011) with cathodal stimulation (decreased excitability) of the left ATL together with anodal stimulation (increased excitability) of the right ATL. We found hemispheric differences in that a stimulation montage involving the opposite polarities did not facilitate performance. Our findings are consistent with the theory that inhibition to the left ATL can lead to a cognitive style that is less influenced by mental templates and that the right ATL may be associated with insight or novel meaning. Further studies including neurophysiological imaging are needed to elucidate the specific mechanisms leading to the enhancement.

Electrical stimulation (EStim) has been shown to promote bone healing and regeneration both in animal experiments and clinical treatments. Therefore, incorporating EStim into promising new bone tissue engineering (BTE) therapies is a logical next step. The goal of current BTE research is to develop combinations of cells, scaffolds, and chemical and physical stimuli that optimize treatment outcomes. Recent studies demonstrating EStim’s positive osteogenic effects at the cellular and molecular level provide intriguing clues to the underlying mechanisms by which it promotes bone healing. In this review, we discuss results of recent in vitro and in vivo research focused on using EStim to promote bone healing and regeneration and consider possible strategies for its application to improve outcomes in BTE treatments. Technical aspects of exposing cells and tissues to EStim in in vitro and in vivo model systems are also discussed.