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https://www.readbyqxmd.com/read/29203450/the-drug-discrimination-assay-interpretative-value-of-partial-generalization-for-drug-schedule-control-actions
#1
David V Gauvin, Zachary J Zimmermann, Robert Code, Theodore J Baird
The U.S. Food & Drug Administration (FDA) has issued a final guidance document on the preclinical determination of abuse potential that must be conducted in animals for all new molecular entities (NMEs) submitted for a new drug application (NDA). Under statutory restrictions government guidance documents serve only as a guide or an expression of the agency's current thinking on the topic. Guidelines do not legally bind the agency or its registrants to any content in the guidance. There are no statutory (legal) descriptions of what study designs or methodology must be submitted to the Drug Enforcement Administration with respect to drug scheduling review...
December 1, 2017: Journal of Pharmacological and Toxicological Methods
https://www.readbyqxmd.com/read/29202270/effects-of-neuromuscular-electrical-stimulation-on-contralateral-quadriceps-function
#2
Thomas Cattagni, Romuald Lepers, Nicola A Maffiuletti
Because maximal voluntary strength of the knee extensor muscles can be facilitated by the concomitant application of neuromuscular electrical stimulation (NMES) to the contralateral homologous muscle, we aimed to determine whether this was associated with an enhanced neural drive to the agonist muscles. A secondary goal of this study was to examine the potential dose-response relationship between NMES intensity and contralateral facilitation. Twelve healthy men (age: 30 ± 7 yr) completed several maximal voluntary contractions (MVC) of the left knee extensors while the right quadriceps received low-intensity NMES (10% MVC), high-intensity NMES (30% MVC) or no NMES...
November 28, 2017: Journal of Electromyography and Kinesiology
https://www.readbyqxmd.com/read/29200638/effect-of-neuromuscular-electrical-stimulation-on-lip-strength-and-closure-function-in-patients-with-dysphagia-after-stroke
#3
Dong-Hwan Oh, Ji-Su Park, Won-Jin Kim
[Purpose] This study aimed to investigate the effect of neuromuscular electrical stimulation (NMES) on lip strength and closure function of patients with dysphagia after stroke. [Subjects and Methods] Eight patients with dysphagia were recruited. NMES was applied to the orbicularis oris muscle. All the participants received NMES for 30 min/d, 5 d/wk, for 4 weeks. Lip strength was measured using the Iowa Oral Performance Instrument. To assess lip closure, the lip closure subitem of the videofluoroscopic dysphagia scale was used...
November 2017: Journal of Physical Therapy Science
https://www.readbyqxmd.com/read/29200627/effect-of-motor-imagery-training-and-electromyogram-triggered-neuromuscular-electrical-stimulation-on-lower-extremity-function-in-stroke-patients-a-pilot-trial
#4
Ji-Hoon Kim, Young-Seok Cho, Ji-Su Park, Won-Jin Kim
[Purpose] To investigate the effect of motor imagery training and electromyogram-triggered neuromuscular electrical stimulation (MIT-EMG NMES) on the lower extremity function of stroke patients. [Subjects and Methods] This study recruited eight patients with hemiplegia due to stroke. All patients received MIT-EMG NMES for 20 min daily, 5 days per week for 4 weeks. Lower extremity function were assessed using the timed up-and-go (TUG) and 10-meter walk (10MW) tests. [Results] The results of TUG test decreased significantly from 20...
November 2017: Journal of Physical Therapy Science
https://www.readbyqxmd.com/read/29183339/effect-of-emg-triggered-neuromuscular-electrical-stimulation-with-bilateral-arm-training-on-hemiplegic-shoulder-pain-and-arm-function-after-stroke-a-randomized-controlled-trial
#5
Li-Ling Chuang, You-Lin Chen, Chih-Chung Chen, Yen-Chen Li, Alice May-Kuen Wong, An-Lun Hsu, Ya-Ju Chang
BACKGROUND: Hemiplegic shoulder pain is a frequent complication after stroke, leading to limited use of the affected arm. Neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) are two widely used interventions to reduce pain, but the comparative efficacy of these two modalities remains uncertain. The purpose of this research was to compare the immediate and retained effects of EMG-triggered NMES and TENS, both in combination with bilateral arm training, on hemiplegic shoulder pain and arm function of stroke patients...
November 28, 2017: Journal of Neuroengineering and Rehabilitation
https://www.readbyqxmd.com/read/29164749/effects-of-neuromuscular-electrical-stimulation-on-the-frequency-of-skeletal-muscle-cramps-a-prospective-controlled-clinical-trial
#6
Michael Behringer, Jan-Frieder Harmsen, Alessandro Fasse, Joachim Mester
OBJECTIVES: We investigated if neuromuscular electrical stimulation (NMES) of calf muscles prevents spontaneous calf cramps. MATERIALS AND METHODS: In 19 individuals affected by more than or equal to one calf cramp per week the gastrocnemius of the predominantly affected leg was stimulated twice a week (intervention leg, IL) over six weeks (3 × 6 stimulation trains at 30 Hz above the individual cramp threshold frequency). The other leg served as control (CL). The participants were advised to record all spontaneous muscle cramps from two weeks before the intervention until two weeks after the last NMES session...
November 22, 2017: Neuromodulation: Journal of the International Neuromodulation Society
https://www.readbyqxmd.com/read/29162949/neuromuscular-electrical-stimulation-for-treatment-of-muscle-impairment-critical-review-and-recommendations-for-clinical-practice
#7
Ethne L Nussbaum, Pamela Houghton, Joseph Anthony, Sandy Rennie, Barbara L Shay, Alison M Hoens
Purpose: In response to requests from physiotherapists for guidance on optimal stimulation of muscle using neuromuscular electrical stimulation (NMES), a review, synthesis, and extraction of key data from the literature was undertaken by six Canadian physical therapy (PT) educators, clinicians, and researchers in the field of electrophysical agents. The objective was to identify commonly treated conditions for which there was a substantial body of literature from which to draw conclusions regarding the effectiveness of NMES...
2017: Physiotherapy Canada. Physiothérapie Canada
https://www.readbyqxmd.com/read/29161465/neuromuscular-electrical-stimulation-for-the-prevention-of-venous-thromboembolism
#8
REVIEW
Shahab Hajibandeh, Shahin Hajibandeh, George A Antoniou, James Rh Scurr, Francesco Torella
BACKGROUND: Venous thromboembolism (VTE) is a serious but preventable cause of morbidity and mortality. Neuromuscular electrical stimulation systems (NMES) for the prevention of VTE may be beneficial for patients in whom pharmacological or standard mechanical prophylaxis methods are contraindicated or are regarded as unsafe or impractical. Although findings of experimental studies suggest that NMES reduce venous stasis, the clinical utility and effectiveness of NMES in VTE prevention remain controversial...
November 21, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29148138/artificial-walking-technologies-to-improve-gait-in-cerebral-palsy-multichannel-neuromuscular-stimulation
#9
Jessica Rose, Katelyn Cahill-Rowley, Erin E Butler
Cerebral palsy (CP) is the most common childhood motor disability and often results in debilitating walking abnormalities, such as flexed-knee and stiff-knee gait. Current medical and surgical treatments are only partially effective in improving gait abnormalities and may cause significant muscle weakness. However, emerging artificial walking technologies, such as step-initiated, multichannel neuromuscular electrical stimulation (NMES), can substantially improve gait patterns and promote muscle strength in children with spastic CP...
November 2017: Artificial Organs
https://www.readbyqxmd.com/read/29144103/effects-of-home-based-superimposed-neuromuscular-electrical-stimulation-in-severe-chronic-obstructive-pulmonary-disease-patients-a-randomized-controlled-clinical-trial
#10
Marie C Valenza, Irene Torres-Sánchez, Laura López-López, Irene Cabrera-Martos, Araceli Ortiz-Rubio, Gerald Valenza-Demet
BACKGROUND: COPD patients experience a sustained deterioration of several capacities. Those with severe COPD undergo a considerable decline in their physical and functional capacities, but pulmonary rehabilitation (PR) is used to reduce the weakness of such patients. To date, neuromuscular electrical stimulation (NMES) has been used in acute COPD patients but NMES superimposed onto voluntary muscular contraction has not been tested in COPD patients. AIM: The aim of this study was to evaluate the effects of superimposed NMES on the cardiorespiratory performance and functionality of severe COPD patients undergoing a home-based rehabilitation program...
November 16, 2017: European Journal of Physical and Rehabilitation Medicine
https://www.readbyqxmd.com/read/29126338/effect-of-neuromuscular-electrical-stimulation-on-brain-derived-neurotrophic-factor
#11
Toshiaki Miyamoto, Keihou Kou, Hideya Yanamoto, Saya Hashimoto, Mai Ikawa, Takashi Sekiyama, Yoshiki Nakano, Shin-Ichiro Kashiwamura, Chisako Takeda, Hiroyuki Fujioka
Brain-derived neurotrophic factor (BDNF) has been considered an essential mediator responsible for the beneficial effects of physical activity in preventing cognitive impairment. This study aimed at examining the effects of a single bout of neuromuscular electrical stimulation (NMES) on levels of BDNF in the plasma and on cognitive performance in healthy adult men. Thirteen healthy adult men participated in three experimental sessions. The first session was 30 min of NMES to both legs, the second was 30 min of cycling exercise at the intensity of 60% peak oxygen uptake, and the third was 30 min of complete rest...
November 10, 2017: International Journal of Sports Medicine
https://www.readbyqxmd.com/read/29110426/functional-near-infrared-spectroscopy-to-probe-sensorimotor-region-activation-during-electrical-stimulation-evoked-movement
#12
Makii Muthalib, Marco Ferrari, Valentina Quaresima, Graham Kerr, Stephane Perrey
This study used non-invasive functional near-infrared spectroscopy (fNIRS) neuroimaging to monitor bilateral sensorimotor region activation during unilateral voluntary (VOL) and neuromuscular electrical stimulation (NMES)-evoked movements. METHODS: In eight healthy male volunteers, fNIRS was used to measure relative changes in oxyhaemoglobin (O2 Hb) and deoxyhaemoglobin (HHb) concentrations from a cortical sensorimotor region of interest in the left (LH) and right (RH) hemispheres during NMES-evoked and VOL wrist extension movements of the right arm...
November 7, 2017: Clinical Physiology and Functional Imaging
https://www.readbyqxmd.com/read/29059108/neuromuscular-electrical-stimulation-superimposed-on-movement-early-after-acl-surgery
#13
Luciana Labanca, Jacopo Emanuele Rocchi, Luca Laudani, Rita Guitaldi, Alessandro Virgulti, Pier Paolo Mariani, Andrea Macaluso
PURPOSE: Quadriceps weakness and asymmetrical loading of lower limbs are two major issues following anterior cruciate ligament reconstruction (ACLR). The aim of this study was to evaluate the effectiveness of a 6-week training protocol involving neuromuscular electrical stimulations (NMES) of the quadriceps muscle superimposed on repeated sit-to-stand-to-sit exercises (STSTS), as an additional treatment to standard rehabilitation, from the 15th to the 60th day following ACLR. METHODS: Sixty-three ACLR patients were randomly allocated to one of the three treatment groups: NMES superimposed on STSTS (NMES+STSTS), STSTS only, or no additional treatment (NAT) to standard rehabilitation...
October 20, 2017: Medicine and Science in Sports and Exercise
https://www.readbyqxmd.com/read/29056852/analysis-of-safety-related-regulatory-actions-for-new-drugs-in-japan-by-nature-of-identified-risks
#14
Makoto Fujikawa, Shunsuke Ono
BACKGROUND: Mechanisms underlying safety events may be heterogeneous and depend on conditions of development and marketing, including the populations studied in clinical trials and the amount of data required for approval, especially under pathways for accelerated access. OBJECTIVE: This study was conducted to investigate possible factors affecting the first post-marketing safety-related regulatory actions (SRRAs) after launch of new drugs in Japan. METHODS: We studied 338 new molecular entities (NMEs) approved in Japan between 2004 and 2014...
2017: Pharmaceutical Medicine
https://www.readbyqxmd.com/read/29044455/use-of-an-app-controlled-neuromuscular-electrical-stimulation-system-for-improved-self-management-of-knee-conditions-and-reduced-costs
#15
Morad Chughtai, Nicholas Piuzzi, George Yakubek, Anton Khlopas, Nipun Sodhi, Assem A Sultan, Salahuddin Nasir, Benjamin S T Yates, Anil Bhave, Michael A Mont
Patients suffering from quadriceps muscle weakness secondary to osteoarthritis or after surgeries, such as total knee arthroplasty, appear to benefit from the use of neuromuscular electrical stimulation (NMES), which can improve muscle strength and function, range of motion, exercise capacity, and quality of life. Several modalities exist that deliver this therapy. However, with the ever-increasing demand to improve clinical efficiency and costs, digitalize healthcare, optimize data collection, improve care coordination, and increase patient compliance and engagement, newer devices incorporating technologies that facilitate these demands are emerging...
October 12, 2017: Surgical Technology International
https://www.readbyqxmd.com/read/29023279/syncope-episodes-and-blood-flow-restriction-training
#16
Juan Martín-Hernández, Alejandro Santos-Lozano, Carl Foster, Alejandro Lucia
The combination of low-load resistance training [or more recently, neuromuscular electrical stimulation (NMES)] with a moderate local blood flow restriction (BFR) is becoming a widespread training and rehabilitation method. Scientific data indicate the overall safety of BFR, at least in healthy young people. However, it has been associated with side effects, usually minor, and further research is warranted regarding the safety and efficacy of this technique, especially in clinical populations. We found 3 syncope/presyncopal episodes among 21 healthy people (9 men), all occurring in men and during familiarization sessions (in which BFR was applied alone) but not thereafter (BFR sessions combined with NMES): 1 subject experienced a brief syncope and 2 other subjects exhibited presyncopal symptoms (sweating, lightheadedness, and pallor)...
October 6, 2017: Clinical Journal of Sport Medicine: Official Journal of the Canadian Academy of Sport Medicine
https://www.readbyqxmd.com/read/29021917/a-feasibility-pilot-using-telehealth-videoconference-monitoring-of-home-based-nmes-resistance-training-in-persons-with-spinal-cord-injury
#17
Ashraf S Gorgey, Robert M Lester, Rodney C Wade, Refka E Khalil, Rehan K Khan, Melodie L Anderson, Teodoro Castillo
INTRODUCTION: The objective of the study was to investigate the feasibility and initial efficacy of telehealth communication in conjunction with surface neuromuscular electrical stimulation (NMES) resistance training (RT) to induce muscle hypertrophy. MATERIALS AND METHODS: This was a home-based setting of within-subject control design of trained vs controlled limbs. Five men with chronic (>1 year postinjury) motor-complete spinal cord injury (SCI) participated in a twice-weekly telehealth videoconference program using home-based NMES-RT for 8 weeks...
2017: Spinal Cord Series and Cases
https://www.readbyqxmd.com/read/29016401/evaluation-of-the-effectiveness-of-neuromuscular-electrical-stimulation-after-total-knee-arthroplasty-a-meta-analysis
#18
Alessandro Bistolfi, Jessica Zanovello, Riccardo Ferracini, Fabrizio Allisiardi, Elisa Lioce, Ernesta Magistroni, Paola Berchialla, Ilaria Da Rold, Giuseppe Massazza
OBJECTIVE: to evaluate the efficacy of the use of the neuromuscular electrical stimulation (NMES) after total knee arthroplasty (TKA). DESIGN: a systematic review of randomized controlled trials (MEDLINE, PubMed, Cochrane Library, and PEDro) using PICOS approach to formulate the research question, Controlled terms and Boolean operators. Inclusion and exclusion criteria were defined in advance. "Neuromuscular electrical stimulation" and "total knee arthroplasty" were used as keywords...
October 7, 2017: American Journal of Physical Medicine & Rehabilitation
https://www.readbyqxmd.com/read/28990434/therapeutic-effect-evaluation-of-neuromuscular-electrical-stimulation-with-or-without-strengthening-exercise-on-spastic-cerebral-palsy
#19
Ya-Chao Qi, Xiao-Li Niu, Ya-Ran Gao, He-Bo Wang, Ming Hu, Li-Peng Dong, Ya-Zhou Li
The aims of this study were to investigate the effect of neuromuscular electrical stimulation (NMES) combined with strengthening exercise on movement in children with spastic cerebral palsy (CP). One hundred children with spastic CP were randomly divided into a treatment group (NMES and strengthening exercise, n = 50) and a control group (only NMES, n = 50). We compared the Comprehensive Spasticity Scale (CSS) score, Gross Motor Function Measure (GMFM) score, and walking speed before treatment and 6 weeks and 3 months after treatment between the 2 groups...
October 1, 2017: Clinical Pediatrics
https://www.readbyqxmd.com/read/28979130/relevance-of-the-weber-effect-in-contemporary-pharmacovigilance-of-oncology-drugs
#20
Ankur Arora, Rajinder K Jalali, Divya Vohora
BACKGROUND: Numerous reporting biases have been known to affect spontaneous reporting databases. The Weber effect, which constitutes a peak in adverse event (AE) reporting of a drug at the end of second year after regulatory approval followed by a continuous decline thereafter, has been considered an important bias for a long time. The existence of this bias in AE reporting of oncology drugs remains an underevaluated area, prompting a targeted examination. METHODS: The US Food and Drug Administration (USFDA) Adverse Event Reporting System (FAERS) was studied for AE reporting patterns of 5 years of 15 new molecular entities (NMEs) and biologics used in oncology...
2017: Therapeutics and Clinical Risk Management
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