Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres

Christoph Neuwirth; Nathalie Braun; Kristl G. Claeys; Robert Bucelli; Christina Fournier; Mark Bromberg; Susanne Petri; Stephan Goedee; Timothée Lenglet; Ron Leppanen; Antonio Canosa; Ira Goodman; Muhammad Al-Lozi; Takuya Ohkubo; Annemarie Hübers; Nazem Atassi; Agessandro Abrahao; Andreas Funke; Martin Appelfeller; Anke Tümmler; Eoin Finegan; Jonathan D. Glass; Suma Babu; Shafeeq S. Ladha; Olga Kwast-Rabben; Raul Juntas-Morales; Amina Coffey; Vinay Chaudhry; Tuan Vu; Chow Saephanh; Colleen Newhard; Marion Zakrzewski; Esther Rosier; Nancy Hamel; Divisha Raheja; Jesper Raaijman; Toby Ferguson; Markus Weber

doi:10.1016/j.clinph.2018.04.614

Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres

Christoph Neuwirth, Nathalie Braun, Kristl G. Claeys, Robert Bucelli, Christina Fournier, Mark Bromberg, Susanne Petri, Stephan Goedee, Timothée Lenglet, Ron Leppanen, Antonio Canosa, Ira Goodman, Muhammad Al-Lozi, Takuya Ohkubo, Annemarie Hübers, Nazem Atassi, Agessandro Abrahao, Andreas Funke, Martin Appelfeller, Anke TümmlerEoin Finegan, Jonathan D. Glass, Suma Babu, Shafeeq S. Ladha, Olga Kwast-Rabben, Raul Juntas-Morales, Amina Coffey, Vinay Chaudhry, Tuan Vu, Chow Saephanh, Colleen Newhard, Marion Zakrzewski, Esther Rosier, Nancy Hamel, Divisha Raheja, Jesper Raaijman, Toby Ferguson, Markus Weber

Research output: Contribution to journal › Article › peer-review

53 Scopus citations

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 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.

Original language	English
Pages (from-to)	1756-1762
Number of pages	7
Journal	Clinical Neurophysiology
Volume	129
Issue number	8
DOIs	https://doi.org/10.1016/j.clinph.2018.04.614
State	Published - Aug 2018

Keywords

Implementation
MUNIX
Multicentre
Training
Variability

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Neuwirth, C., Braun, N., Claeys, K. G., Bucelli, R., Fournier, C., Bromberg, M., Petri, S., Goedee, S., Lenglet, T., Leppanen, R., Canosa, A., Goodman, I., Al-Lozi, M., Ohkubo, T., Hübers, A., Atassi, N., Abrahao, A., Funke, A., Appelfeller, M., ... Weber, M. (2018). Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres. Clinical Neurophysiology, 129(8), 1756-1762. https://doi.org/10.1016/j.clinph.2018.04.614

@article{caadfb9e66b14c309c8a07ae4fb52b4e,

title = "Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres",

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 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.",

keywords = "Implementation, MUNIX, Multicentre, Training, Variability",

author = "Christoph Neuwirth and Nathalie Braun and Claeys, {Kristl G.} and Robert Bucelli and Christina Fournier and Mark Bromberg and Susanne Petri and Stephan Goedee and Timoth{\'e}e Lenglet and Ron Leppanen and Antonio Canosa and Ira Goodman and Muhammad Al-Lozi and Takuya Ohkubo and Annemarie H{\"u}bers and Nazem Atassi and Agessandro Abrahao and Andreas Funke and Martin Appelfeller and Anke T{\"u}mmler and Eoin Finegan and Glass, {Jonathan D.} and Suma Babu and Ladha, {Shafeeq S.} and Olga Kwast-Rabben and Raul Juntas-Morales and Amina Coffey and Vinay Chaudhry and Tuan Vu and Chow Saephanh and Colleen Newhard and Marion Zakrzewski and Esther Rosier and Nancy Hamel and Divisha Raheja and Jesper Raaijman and Toby Ferguson and Markus Weber",

note = "Publisher Copyright: {\textcopyright} 2018 International Federation of Clinical Neurophysiology",

year = "2018",

month = aug,

doi = "10.1016/j.clinph.2018.04.614",

language = "English",

volume = "129",

pages = "1756--1762",

journal = "Clinical Neurophysiology",

issn = "1388-2457",

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Neuwirth, C, Braun, N, Claeys, KG, Bucelli, R, Fournier, C, Bromberg, M, Petri, S, Goedee, S, Lenglet, T, Leppanen, R, Canosa, A, Goodman, I, Al-Lozi, M, Ohkubo, T, Hübers, A, Atassi, N, Abrahao, A, Funke, A, Appelfeller, M, Tümmler, A, Finegan, E, Glass, JD, Babu, S, Ladha, SS, Kwast-Rabben, O, Juntas-Morales, R, Coffey, A, Chaudhry, V, Vu, T, Saephanh, C, Newhard, C, Zakrzewski, M, Rosier, E, Hamel, N, Raheja, D, Raaijman, J, Ferguson, T & Weber, M 2018, 'Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres', Clinical Neurophysiology, vol. 129, no. 8, pp. 1756-1762. https://doi.org/10.1016/j.clinph.2018.04.614

TY - JOUR

T1 - Implementing Motor Unit Number Index (MUNIX) in a large clinical trial

T2 - Real world experience from 27 centres

AU - Neuwirth, Christoph

AU - Braun, Nathalie

AU - Claeys, Kristl G.

AU - Bucelli, Robert

AU - Fournier, Christina

AU - Bromberg, Mark

AU - Petri, Susanne

AU - Goedee, Stephan

AU - Lenglet, Timothée

AU - Leppanen, Ron

AU - Canosa, Antonio

AU - Goodman, Ira

AU - Al-Lozi, Muhammad

AU - Ohkubo, Takuya

AU - Hübers, Annemarie

AU - Atassi, Nazem

AU - Abrahao, Agessandro

AU - Funke, Andreas

AU - Appelfeller, Martin

AU - Tümmler, Anke

AU - Finegan, Eoin

AU - Glass, Jonathan D.

AU - Babu, Suma

AU - Ladha, Shafeeq S.

AU - Kwast-Rabben, Olga

AU - Juntas-Morales, Raul

AU - Coffey, Amina

AU - Chaudhry, Vinay

AU - Vu, Tuan

AU - Saephanh, Chow

AU - Newhard, Colleen

AU - Zakrzewski, Marion

AU - Rosier, Esther

AU - Hamel, Nancy

AU - Raheja, Divisha

AU - Raaijman, Jesper

AU - Ferguson, Toby

AU - Weber, Markus

PY - 2018/8

Y1 - 2018/8

N2 - 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 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.

AB - 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 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.

KW - Implementation

KW - MUNIX

KW - Multicentre

KW - Training

KW - Variability

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U2 - 10.1016/j.clinph.2018.04.614

DO - 10.1016/j.clinph.2018.04.614

M3 - Article

C2 - 29803404

AN - SCOPUS:85047293890

SN - 1388-2457

VL - 129

SP - 1756

EP - 1762

JO - Clinical Neurophysiology

JF - Clinical Neurophysiology

IS - 8

ER -

Implementing Motor Unit Number Index (MUNIX) in a large clinical trial: Real world experience from 27 centres

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Keywords

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