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"Electric Stimulation - methods"
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Neuromuscular electrical stimulation for physical function maintenance during hematopoietic stem cell transplantation: Study protocol
2024
Hematopoietic stem cell transplantation is a common life-saving treatment for hematologic malignancies, though can lead to long-term functional impairment, fatigue, muscle atrophy, with decreased quality of life. Although traditional exercise has helped reduce these effects, it is inconsistently recommended and infrequently maintained, and most patients remain sedentary during and after treatment. There is need for alternative rehabilitation strategies, like neuromuscular electrical stimulation, that may be more amenable to the capabilities of hematopoietic stem cell transplant recipients. Patients receiving autologous HCT are being enroled in a randomized controlled trial with 1:1 (neuromuscular electrical stimulation:sham) design stratified by diagnosis and sex. Physical function, body composition, quality of life, and fatigue are assessed prior to hematopoietic stem cell transplant (prior to initiating preparatory treatment) and 24±5 days post hematopoietic stem cell transplant (Follow-up 1); physical function and quality of life are also assessed 6-months post hematopoietic stem cell transplant (Follow-up 2). The primary outcome is between-group difference in the 6-minute walk test change scores (Follow-up 1—Pre-transplant; final enrolment goal N = 23/group). We hypothesize that 1) neuromuscular electrical stimulation will attenuate hematopoietic stem cell transplant-induced adverse effects on physical function, muscle mass, quality of life, and fatigue compared to sham at Follow-up 1, and 2) Pre-transplant physical function will significantly predict fatigue and quality of life at Follow-up 2. We will also describe feasibility and acceptability of neuromuscular electrical stimulation during hematopoietic stem cell transplant. This proposal will improve rehabilitative patient care and quality of life by determining efficacy and feasibility of a currently underutilized therapeutic strategy aimed at maintaining daily function and reducing the impact of a potent and widely used cancer treatment. This trial is registered with clinicaltrials.gov (NCT04364256).
Journal Article
Stochastic galvanic vestibular stimulation improves kinetic performance in adolescent idiopathic scoliosis during obstacle negotiation
by
Xie, Haoyu
,
Chien, Jung Hung
,
Wang, Chuhuai
in
Adolescent
,
Adolescents
,
Biomechanical Phenomena - physiology
2025
Vestibular dysfunction has been reported as a potential cause in adolescent idiopathic scoliosis (AIS). However, it remained unclear how stochastic galvanic vestibular stimulation (GVS) affected kinetic performance of patients with AIS. This study aimed to investigate the effect of stochastic GVS on ground reaction forces (GRF) measures during obstacle negotiation among patients with AIS. Fifteen patients with AIS and 15 age/sex-matched healthy controls (HC) participated in this study. Stochastic GVS was applied via electrodes placed over bilateral mastoid process with the intensity of 80% of individual sensory thresholds. Six walking trials including 2 types of GVS (stochastic GVS/sham stimulation) and 3 obstacle conditions (Level/Low/High) were randomly allocated to each participant, and each trial was repeated 3 times. Four AMTI force plates were used to measure GRF peaks and impulses in anterior-posterior (AP
1
/AP
2
), medial-lateral (ML
1
/ML
2
), and vertical (V
1
/V
2
) directions. Significant interactions were observed in AP
1
(F
2,56
=3.537,
p
= 0.036), V
1
(F
2,56
=4.118,
p
= 0.021), ML
1
(F
2,56
=3.313,
p
= 0.044) and medial-lateral impulses (F
2,56
=4.386,
p
= 0.017) for the step negotiating obstacles.
Post-hoc
comparisons showed that in comparison to sham stimulation, the application of stochastic GVS significantly (1) increased AP
1
(Low:
p
= 0.038) and V
1
(Low:
p
< 0.001; High:
p
= 0.035) in two groups; (2) decreased ML
1
of two groups (AIS:
ps
< 0.01; HC:
ps
< 0.05) and medial-lateral impulses in patients with AIS (Low:
p
= 0.013; High:
p
= 0.015) during obstacle negotiation. Additionally, the rates of change in ML
1
and medial-lateral impulses among patients with AIS were significantly higher than that of HC, indicating that stochastic GVS demonstrated a greater effect of decreasing ML
1
and medial-lateral impulses in AIS. Stochastic GVS ameliorated kinetic performance of patients with AIS during obstacle negotiation, and its potential mechanism may involve the induction of stochastic resonance phenomenon to enhance vestibular perception. Our study offered stochastic GVS as a novel approach to target vestibular-related postural instability in AIS.
Journal Article
Facilitate Insight by Non-Invasive Brain Stimulation
2011
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.
Journal Article
Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) Therapy for Post Stroke Arm spasticity: study protocol for a 3-arm, a partially blinded, randomised controlled trial
by
Baster, Kathleen
,
Adebajo, Adewale
,
Reeves, Mark
in
Anesthesia
,
Arm - physiopathology
,
Botulinum toxin
2024
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).
Journal Article
Effects of Rehabilitative Exercise and Neuromuscular Electrical Stimulation on Muscle Morphology and Dynamic Balance in Individuals with Chronic Ankle Instability
2024
Background and Objectives: Muscle atrophy caused by chronic ankle instability (CAI) can incur muscle weakness, altered movement patterns, and increased risk of injury. Previous studies have investigated the effects of rehabilitative exercises and neuromuscular electrical stimulation (NMES) on characteristics in CAI individuals, but few studies have examined their effects on foot and ankle muscle morphology. This study aimed to determine the effects of rehabilitative exercises and NMES on muscle morphology and dynamic balance in individuals with CAI. Materials and Methods: Participants with CAI (n = 47) were randomly divided into control (CG), rehabilitative exercise (REG), NMES (NG), and rehabilitative exercise and NMES combined (RNG) groups. The six-week intervention program consisting of rehabilitative exercises and NMES was applied to groups excluding CG. Muscle morphology and dynamic balance were evaluated using a portable wireless diagnostic ultrasound device and dynamic balance tests. For statistical analysis, an effect size with 95% confidence interval was calculated to assess mean differences according to intervention. Results: After six weeks, significant increases in morphology and dynamic balance were observed for all muscles except flexor hallucis longus (p > 0.05) in the intervention groups except for CG. However, no significant changes were observed in the CG (p > 0.05). Conclusions: These findings suggest that intervention programs may help prevent muscle atrophy and improve balance in CAI individuals.
Journal Article
Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder
2025
Objectives
To evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients.
Patients
Participants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.
Methods
The subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention sessions weekly. The primary endpoint was the change in Overactive Bladder Symptom Score (OABSS) at week 12 from the baseline.
Results
Of the 109 recruited OAB patients. In the TNS-01 group, the OABSS change from baseline at week 12 was significantly higher than that in the sham group (2.83 ± 2.53 vs 1.62 ± 2.59,
p
= 0.02). The absolute and percent changes of average UUI episodes per day from baseline at week 8 in the TNS-01 group were significantly lower from those in the sham group (0.11 ± 1.33 vs 0.68 ± 2.14,
p
= 0.01; − 27.82% ± 167.33% vs 87.18% ± 25.20%,
p
= 0.04). One treatment-related adverse event (hematuria) was reported by one patient (1.8%) in the sham group.
Conclusions
The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation.
Trial registration number:
NCT04999657.
Journal Article
Comparison of Whole-Body Electromyostimulation versus Recognized Back-Strengthening Exercise Training on Chronic Nonspecific Low Back Pain: A Randomized Controlled Study
2019
Background. Low back pain (LBP) affects almost everyone at least once in their lifetime. Various meta-analyses show promising effects on pain reduction for conventional exercise. However, the lack of time and, especially for pain patients, a fear of movement (“kinesiophobia”) as well as functional limitations often oppose participation in such activities. In contrast, the advantage of novel training technologies like whole-body electromyostimulation (WB-EMS) lies particularly in a joint-friendly, time-effective, and highly customized training protocol and might be an alternative option for LBP patients. A meta-analysis of individual patient data and a comparison of WB-EMS against a passive control group confirmed the proof principle. Thus, the aim of this randomized controlled trial is to compare WB-EMS with a recognized back-strengthening exercise protocol to determine the corresponding effects on chronic, nonspecific LBP in people suffering from this. Methods and Findings. This randomized, controlled multicenter study is focused on novel and time-effective training technologies and LBP. In this contribution, the focus is primarily on the comparison of WB-EMS against a comparable conventional exercise training (CT). One hundred ten nonspecific chronic LBP patients, 40–70 years old, were randomly allocated to the intervention arms (WB-EMS: 55 vs. CT: 55). Both groups completed a 12-week program (WB-EMS: 1 × 20 min/week vs. CT: 1 × 45 min/week) specifically dedicated to LBP. The selection of the content of the active control group was based on the principles of WB-EMS training, which uses electrical stimulation to train mainly strength and stabilization in a very short time. Exercises were similar in all groups, with the focus on strengthening and stabilizing the trunk. Outcome measures were assessed by a four-week pain diary (before and during the last four weeks of intervention) as well as an isometric maximum strength measurement of the trunk muscles at baseline and after 12 weeks of intervention. Primary study endpoint was average pain intensity at the lumbar spine. Secondary study endpoints were maximum isometric strength of the back and the abdominals. The mean pain intensity of LBP decreased significantly in both groups (WB-EMS: −22.3 ± 20.9% vs. CT: −30.2 ± 43.9%; p<0.001), however, without significant intergroup difference (p=0.160). A similar result was observed for “maximum isometric strength of trunk muscles.” The increase in back strength (WB-EMS: 15.6 ± 24.9% vs. CT: 23.0 ± 30.9%) was highly significant in both groups (p=0.001), and similar changes were observed for the trunk flexors (WB-EMS: 17.6 ± 24.8% vs. CT: 18.1 ± 24.8%). Also, at the secondary endpoint, no significant difference in pairwise comparison was observed in both cases (extension: p=0.297; flexion: p=0.707). Conclusion. In summary, both, WB-EMS and conventional back-strengthening protocol are comparably effective in reducing nonspecific chronic LBP in this dedicated cohort. The result is particularly positive in terms of time effectiveness and offers an adequate alternative for people with limited time resources or other barriers to conventional training methods.
Journal Article
No effect of intradialytic neuromuscular electrical stimulation on inflammation and quality of life: a randomized and parallel design clinical trial
by
Lobo, Patrícia C. B.
,
Monteiro, Paula A.
,
Motobu, Reika D.
in
692/4022
,
692/4022/1585
,
692/4022/1950
2021
Neuromuscular electrical stimulation (NMES) elicits muscle contraction and has been shown to improvement of quality of life. However, if NMES improvement the quality of life and attenuate the inflammation is not fully understood. Therefore, our aim sought to assess the effects of short-term of intradialytic NMES on inflammation and quality of life in patients with chronic kidney disease patients undergoing hemodialysis. A randomized clinical trial conducted with parallel design enrolled adult hemodialysis patients three times a week during 1 month. Patients were randomly assigned to two groups (control group, n = 11; 4F/7 M) or (NMES group, n = 10; 4F/6 M). Pre-and post-intervention, was measured the high-sensitivity C reactive protein, interleukin-6, interleukin-10, and TNFα by the ELISA, and quality of life was applied using the SF-36. During each hemodialysis session, NMES was applied bilaterally at thigh and calves for 40 min. There was not change in cytokines (hs-CRP, IL-6, IL-10, and TNFα) concentrations time × group interaction. In addition, no difference was found in eight domains of quality of life. In addition, the groups did not differ for muscle strength and muscle mass. In conclusion, we found that intradialytic NMES did not change inflammation neither quality of life.
Journal Article
An Open‐Label Comparative Study of the Impact of Two Types of Electrical Stimulation (Direct Current Neuromuscular Electrical Stimulation and Transcutaneous Electrical Stimulation) on Physical Therapy Treatment of Diabetic Peripheral Neuropathy
by
Rizopoulos, Konstantine
,
McGilvrey, Joe
,
von Leden, Ramona
in
Adult
,
Aged
,
Analysis of covariance
2025
Objective: The objective of this study is to evaluate and compare the effectiveness of treatments with two different electrical stimulation (e‐stim) devices—pulsed direct current (DC) (Neubie) and alternating current (AC) (transcutaneous electrical stimulation (TENS))—in the treatment of symptoms for patients with diabetic peripheral neuropathy (DPN). Design: Randomized controlled trial (RCT) with parallel groups. Methods: One hundred fifty participants were recruited from 13 Hands‐On Diagnostics–affiliated sites across several US locations. Participants were randomly divided into two groups for comparison—Neubie and TENS. Participants received a 30‐min foot stimulation protocol with either TENS unit electrodes or Neubie electrodes. Outcome measures included the Toronto Clinical Neuropathy Score (TCNS), two‐point discrimination, visual analogue scale (VAS), vibration sense (VBS), nerve conduction velocity (NCV), and nerve amplitude. The effect of the two variables on all outcome measures was determined using an analysis of covariance (ANCOVA). Results: The Neubie group demonstrated statistically significant improvements in TCNS for both right and left sides ( p < 0.001), two‐point discrimination of the dominant foot ( p = 0.001), VBS ( p = 0.022) and VAS scores ( p = 0.009), and some but not all nerves tested by NCV ( p < 0.05). Conclusion: Overall, DPN treatment with the Neubie resulted in significant improvements in several major outcome measures, whereas TENS showed no significant difference in any outcome measure. These findings support the use of DC devices as a potentially superior therapeutic treatment for neuropathy over AC devices like the TENS unit. Trial Registration: ClinicalTrials.gov identifier: NCT05442021
Journal Article
Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial
by
Lee, Mihyun
,
Yoon, Yong-Soon
,
Jang, Hong-Young
in
Chronic Pain - therapy
,
Clinical trials
,
Control theory
2022
Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG: n = 20) and physical therapy group (PTG: n = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck (p = 0.0425), shoulder (p = 0.0425), and back (p = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG (p = 0.0098), and PLSG (p = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.
Journal Article