Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres
Neuwirth, Christoph; Braun, Nathalie; Claeys, Kristl G.; Bucelli, Robert; Fournier, Christina; Bromberg, Mark; Petri, Susanne; Goedee, Stephan; Lenglet, Timothée; Leppanen, Ron; Canosa, Antonio; Goodman, Ira; Al-Lozi, Muhammad; Ohkubo, Takuya; Hübers, Annemarie; Atassi, Nazem; Abrahao, Agessandro; Funke, Andreas; Appelfeller, Martin; Tümmler, Anke; Finegan, Eoin; Glass, Jonathan D.; Babu, Suma; Ladha, Shafeeq S.; Kwast-Rabben, Olga; Juntas-Morales, Raul; Coffey, Amina; Chaudhry, Vinay; Vu, Tuan; Saephanh, Chow; Newhard, Colleen; Zakrzewski, Marion; Rosier, Esther; Hamel, Nancy; Raheja, Divisha; Raaijman, Jesper; Ferguson, Toby; Weber, Markus
(2018) Clinical Neurophysiology, volume 129, issue 8, pp. 1756 - 1762
(Article)
Abstract
Objective: Motor Unit Number Index (MUNIX) is a quantitative neurophysiological method that reflects loss of motor neurons in Amyotrophic Lateral Sclerosis (ALS) in longitudinal studies. It has been utilized in one natural history ALS study and one drug trial (Biogen USA) after training and qualification of raters. Methods: Prior to
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testing patients, evaluators had to submit test-retest data of 4 healthy volunteers. Twenty-seven centres with 36 raters measured MUNIX in 4 sets of 6 different muscles twice. Coefficient of variation of all measurements had to be <20% to pass the qualification process. MUNIX COV of the first attempt, number of repeated measurements and muscle specific COV were evaluated. Results: COV varied considerably between raters. Mean COV of all raters at the first measurements was 12.9% ± 13.5 (median 8.7%). Need of repetitions ranged from 0 to 43 (mean 10.7 ± 9.1, median 8). Biceps and first dorsal interosseus muscles showed highest repetition rates. MUNIX variability correlated considerably with variability of compound muscle action potential. Conclusion: MUNIX revealed generally good reliability, but was rater dependent and ongoing support for raters was needed. Significance: MUNIX can be implemented in large clinical trials as an outcome measure after training and a qualification process.
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Keywords: Implementation, Multicentre, MUNIX, Training, Variability, Sensory Systems, Neurology, Clinical Neurology, Physiology (medical)
ISSN: 1388-2457
Publisher: Elsevier Ireland Ltd
Note: Funding Information: This work was supported by the Swiss ALS Foundation, and the EU Joint Programme Neurodegenerative Disease Research (JPND) project. We would like to thank all participating raters, volunteers and Biogen, USA, for the permission to publish the data. Funding Information: This work was supported by the Swiss ALS Foundation , and the EU Joint Programme Neurodegenerative Disease Research (JPND) project. We would like to thank all participating raters, volunteers and Biogen, USA, for the permission to publish the data. Publisher Copyright: © 2018 International Federation of Clinical Neurophysiology
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