ArticleAnnals of clinical and translational neurology2020
Improved ALS clinical trials through frequent at-home self-assessment: a proof of concept study.
Article in Annals of clinical and translational neurology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 52 papers, 4 of them syntheses that pooled it.
What it found
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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.
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.
Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures
Electrical Impedance Myography Via the Myolex mScan as an ALS Biomarker
Who cites it
52 citing papers in PubMed, 4 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- The Use of Digital Devices to Monitor Physical Behavior in Motor Neuron Disease: Systematic Review.Journal of medical Internet research · 2025Pooled it
- The use of digital outcome measures in clinical trials in rare neurological diseases: a systematic literature review.Orphanet journal of rare diseases · 2023Pooled it
- A systematic review of digital technology to evaluate motor function and disease progression in motor neuron disease.Journal of neurology · 2022Pooled it
- The landscape of neurophysiological outcome measures in ALS interventional trials: A systematic review.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2022Pooled it
- Trial
- Evaluation of a self-administered version of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R).Arquivos de neuro-psiquiatria · 2026Observational
- Comparison of Consumer Smartwatch and Research-Grade Accelerometer-Derived Step Counts in Amyotrophic Lateral Sclerosis.Muscle & nerve · 2026Observational
- Surface Electrical Impedance Myography in Assessment of Morphofunctional Changes in Biological Tissues and Biofeedback Interfaces.Sensors (Basel, Switzerland) · 2026Review
- Digital Remote Assessment of Motor and Speech Changes in Amyotrophic Lateral Sclerosis: Longitudinal Observational Study.JMIR formative research · 2026Observational
- Multifrequency Electrical Impedance Myography Enhanced with Machine Learning for Screening Patients with Neuromuscular Disorders.Annals of biomedical engineering · 2026Article
- The Utility of Speech and Language Analytics for Screening Alzheimer's Disease.Neuro-degenerative diseases · 2026Review
- Emergent technologies in clinical neurophysiology to study the neuromuscular system: IFCN handbook chapter.Clinical neurophysiology practice · 2026Review
- Analytical and clinical validation of step counting method in people living with amyotrophic lateral sclerosis.Scientific reports · 2025Article
- Surface electrical impedance myography detects disease in an adult-onset SOD1-G93A zebrafish model of amyotrophic lateral sclerosis.Scientific reports · 2025Article
- Remote Monitoring of Amyotrophic Lateral Sclerosis Using Digital Health Technologies: Shifting Toward Digitalized Care and Research?Neurology · 2025Review
- Wrist accelerometry and machine learning sensitively capture disease progression in prodromal Parkinson's disease.NPJ Parkinson's disease · 2025Article
- Article
- Reliable monitoring of respiratory function with home spirometry in people living with amyotrophic lateral sclerosis.Frontiers in neurology · 2025Article
- Listener effort measures clinically meaningful change of dysarthria in amyotrophic lateral sclerosis.Brain communications · 2025Article
- Operationalizing Clinical Speech Analytics: Moving From Features to Measures for Real-World Clinical Impact.Journal of speech, language, and hearing research : JSLHR · 2024Article
Corrections and comments
- Commented on by
- Commented on by
- Erratum issuedCorrigendum.2021
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine the potential for improving amyotrophic lateral sclerosis (ALS) clinical trials by having patients or caregivers perform frequent self-assessments at home. METHODS AND
participantsWe enrolled ALS patients into a nonblinded, longitudinal 9-month study in which patients and caregivers obtained daily data using several different instruments, including a slow-vital capacity device, a hand grip dynamometer, an electrical impedance myography-based fitness device, an activity tracker, a speech app, and the ALS functional rating scale-revised. Questions as to acceptability were asked at two time points.
resultsA total of 113 individuals enrolled, with 61 (43 men, 18 women, mean age 60.1 ± 9.9 years) collecting a minimum of 7 days data and being included in the analysis. Daily measurements resulted in more accurate assessments of the slope of progression of the disease, resulting in smaller sample size estimates for a hypothetical clinical trial. For example, by performing daily slow-vital capacity measurements, calculated sample size was reduced to 182 subjects/study arm from 882/arm for monthly measurements. Similarly, performing the ALS functional rating scale weekly rather than monthly led to a calculated sample size of 73/arm as compared to 274/arm. Participants generally found the procedures acceptable and, for many, improved their sense of control of their disease.
interpretationFrequent at-home measurements using standard tools holds the prospect of tracking progression and reducing sample size requirements for clinical trials in ALS while also being acceptable to the patients. Future studies in this and other neurological disorders should consider adopting this approach to data collection.
Indexed as
Identifiers
What OpenQuestion holds
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.