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Reducing sample size requirements for future ALS clinical trials with a dedicated electrical impedance myography system.

ABSTRACT: OBJECTIVE:In this longitudinal multicenter cohort study, we evaluated the potential of a dedicated electrical impedance myography (EIM) device to assess ALS progression and the system's basic reproducibility and diagnostic accuracy. METHODS:Forty-six ALS patients underwent up to five sequential measurements of multiple muscles over a period of 8 months at 2-month intervals using the mView EIM device (Myolex, Inc., San Francisco, CA). Standard measures of disease status were also obtained. A group of 30 healthy volunteers and 30 ALS-mimics were evaluated once to determine if the technique could assist with initial diagnosis. Several electrode arrays and EIM outcomes were assessed. RESULTS:EIM tracked ALS progression; power analyses suggested a 5.2-fold reduction in sample size requirements compared to ALSFRS-R by utilizing 50?kHz phase value from the muscle with the greatest EIM decline in each subject. This progression rate correlated to total ALSFRS-R progression, with R?=?0.371, p?=?0.021. Reproducibility was high, with both intra- and inter-rater intraclass correlation coefficients for individual muscles mostly greater than 0.90. The mean 50?kHz phase distinguished between ALS patients and healthy controls (area-under-curve 0.78, 95% confidence intervals (CIs) 0.68, 0.89), but not between mimics and ALS patients (area-under-curve 0.60, 95% CIs 0.47, 0.73). CONCLUSIONS:While limited in its specificity to identify ALS versus disease mimics, these results support the hypothesis that single-muscle EIM can serve as a convenient, repeatable, and powerful outcome measure in ALS clinical trials.

SUBMITTER: Shefner JM

PROVIDER: S-EPMC6438779 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Reducing sample size requirements for future ALS clinical trials with a dedicated electrical impedance myography system.

Shefner Jeremy M JM Rutkove Seward B SB Caress James B JB Benatar Michael M David William S WS Cartwright Michael S MS Macklin Eric A EA Bohorquez Jose L JL

Amyotrophic lateral sclerosis & frontotemporal degeneration 20180928 7-8

<h4>Objective</h4>In this longitudinal multicenter cohort study, we evaluated the potential of a dedicated electrical impedance myography (EIM) device to assess ALS progression and the system's basic reproducibility and diagnostic accuracy.<h4>Methods</h4>Forty-six ALS patients underwent up to five sequential measurements of multiple muscles over a period of 8 months at 2-month intervals using the mView EIM device (Myolex, Inc., San Francisco, CA). Standard measures of disease status were also o ...[more]

PMID: 30265154

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Project description:Background: Electrical impedance myography (EIM) is a non-invasive method that provides information about muscle health and changes that occur within it. EIM is based on the analysis of three impedance variables: resistance, reactance, and the phase angle. This systematic review of the literature provides a deeper insight into the scope and range of applications of EIM in health and physical exercise. The main goal of this work was to systematically review the studies on the applications of EIM in health and physical exercise in order to summarize the current knowledge on this method and outline future perspectives in this growing area, including a proposal for a research agenda. Furthermore, some basic assessment principles are provided. Methods: Systematic literature searches on PubMed, Scopus, SPORTDiscus and Web of Science up to September 2020 were conducted on any empirical investigations using localized bioimpedance devices to perform EIM within health and physical exercise contexts. The search included healthy individuals, elite soccer players with skeletal muscle injury, and subjects with primary sarcopenia. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was used to develop the systematic review protocol. The quality and risk of bias of the studies included were assessed with the AQUA tool. Results: Nineteen eligible original articles were included in this review, which were separated into three tables according to the nature of the study. The first table includes six studies on the bioelectrical characterization of muscle. The second table includes five studies analyzing muscle changes in injured elite soccer players. The third table includes studies on the short-, medium-, and long-term bioelectrical adaptations to physical exercise. Conclusions: EIM has been used for the evaluation of the muscle condition in the clinical field over the last few years, especially in different neuromuscular diseases. It can also play an important role in other contexts as an alternative to complex and expensive methods such as magnetic resonance imaging. However, further research is needed. The main step in establishing EIM as a valid tool in the scientific field is to standardize the protocol for performing impedance assessments.

Project description:Loss of muscle mass and strength represents one of the most significant contributors to impaired function in older adults. Convenient and non-invasive biomarkers are needed that can readily identify and track age-related muscle change. Previous data has suggested electrical impedance myography (EIM) has the potential to serve in this capacity. In this study we investigated how changes in EIM compared with other standard measures of muscle structure and function in aged compared with young mice. A total of 19 male mice aged approximately 25 months and 19 male mice aged 3 months underwent surface multifrequency EIM of the right gastrocnemius muscle using standard methods. Fore and hind limb grip strength, sciatic compound muscle action potential amplitude, and in-situ force of the gastrocnemius were also measured; after sacrifice, gastrocnemius myofiber size was assessed using standard histology. Spearman correlation coefficients were calculated to investigate the association between EIM and muscle characteristics. EIM in aged animals demonstrated significantly lower 50 kHz impedance phase (p<0.001) and reactance (p<0.01) values as well as reduced multifrequency parameters. In contrast, absolute gastrocnemius muscle mass was no different between young and aged mice (p = 0.58) but was reduced in aged mice after normalization to body mass (p<0.001). Median myofiber size in the aged mice was not different from that of young mice (p = 0.72). Aged mice showed reduced muscle function on the basis of normalized fore limb (p<0.001) and normalized hind limb (p<0.001) grip strength, as well as normalized gastrocnemius twitch (p<0.001) and normalized maximal isometric force (p<0.001). Sciatic compound muscle action potential amplitude was reduced in aged mice (p<0.05). EIM parameters showed good correlation with reduced standard physiological and electrophysiological measures of muscle health. Our study suggests that EIM is sensitive to aged-related muscle change and may represent a convenient and valuable method of quantifying loss of muscle health.

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Reducing sample size requirements for future ALS clinical trials with a dedicated electrical impedance myography system.

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Reducing sample size requirements for future ALS clinical trials with a dedicated electrical impedance myography system.

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