Evidence map›Paper›PMID 30265154›Full record

ArticleAmyotrophic lateral sclerosis & frontotemporal degeneration2018

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

Jeremy M Shefner, Seward B Rutkove, James B Caress, Michael Benatar, William S David, Michael S Cartwright, Eric A Macklin, Jose L Bohorquez

2 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in Amyotrophic lateral sclerosis & frontotemporal degeneration, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06491732 recruitingnot on this mapstarted 2025, after this paper: background citation

Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker

TypeobservationalSponsorBeth Israel Deaconess Medical CenterRan2025 to 2027Enrolled80ConditionsAmyotrophic Lateral SclerosisArmsElectrical Impedance Myography
NCT07502989 recruitingnot on this mapstarted 2025, after this paper: background citation

Convenient Quantification of Myopathic Change in Muscle Via Electrical Impedance Myography

Typeobservational_patient_registrySponsorBeth Israel Deaconess Medical CenterRan2025 to 2027Enrolled150ConditionsMyopathy, Muscular Dystrophies, Myositis, Myofibrillar MyopathyArmsElectrical Impedance Myography
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. The landscape of neurophysiological outcome measures in ALS interventional trials: A systematic review.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2022
    Pooled it
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  14. Considerations for Amyotrophic Lateral Sclerosis (ALS) Clinical Trial Design.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jeremy M Shefnera Department of Neurology , Barrow Neurological Institute , Phoenix , AZ , USA.
Seward B Rutkoveb Department of Neurology , Beth Israel Deaconess Medical Center and Harvard Medical School , Boston , MA , USA.
James B Caressc Department of Neurology, Wake Forest School of Medicine , Winston-Salem , NC , USA.
Michael Benatard Department of Neurology , University of Miami , Miami , FL , USA.
William S Davide Department of Neurology , Massachusetts General Hospital and Harvard Medical School , Boston , MA , USA.
Michael S Cartwrightc Department of Neurology, Wake Forest School of Medicine , Winston-Salem , NC , USA.
Eric A Macklinf Biostatistics Center, Massachusetts General Hospital and Harvard Medical School , Boston , MA , USA.
Jose L Bohorquezg Myolex, Inc , San Francisco , CA , USA.

Funding

Noninvasive Assessment of Neuromuscular Disease using Electrical ImpedanceR44NS070385 · NINDS · MYOLEX, INC. · PI LUPTON, ELMER C, RUTKOVE, SEWARD B. · 2012 to 2019
$3.2M
NINDS NIH HHS R44 NS070385
6 · The paper itself

Abstract

objectiveIn 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.

methodsForty-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.

resultsEIM 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).

conclusionsWhile 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.

Indexed as

Electric ImpedanceSample SizeAdultAgedAmyotrophic Lateral SclerosisCohort StudiesDisease ProgressionEvoked Potentials, MotorFemaleHumansMaleMiddle AgedMuscle, SkeletalMuscle Strength DynamometerMyographyVital CapacityALSbiomarkerclinical trialselectrical impedance myographyElectrical impedance myographyoutcomes

Identifiers

PMID30265154
PMCPMC6438779

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.