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. 2024 Dec 28;272(1):89.
doi: 10.1007/s00415-024-12863-7.

Expanded and independent validation of the NoMoFA scale for Parkinson's disease: the Italian version

Roberta Balestrino  1   2   3 , Domiziana Rinaldi  4 , Silvia Galli  5 , Alberto Romagnolo  5   6 , Roberto Erro  7 , Claudia Ledda  5   6 , Giulia Donzuso  8 , Marina Picillo  7 , Claudio Terravecchia  8 , Federica Agosta  1   2   9   10   11 , Paolo Barone  7   12 , Leonardo Lopiano  5   6 , Alessandra Nicoletti  8 , Massimo Filippi  13   14   15   16   17   18   19 , Pablo Martinez-Martin #  20 , Carlo Alberto Artusi #  5   6
Affiliations

Expanded and independent validation of the NoMoFA scale for Parkinson's disease: the Italian version

Roberta Balestrino et al. J Neurol. .

Abstract

Introduction: Non-motor symptoms (NMS) in Parkinson's disease (PD) can fluctuate daily, impacting patient quality of life. The Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire, a recently validated tool, quantifies NMS fluctuations during ON- and OFF-medication states. Our study aimed to validate the Italian version of NoMoFA, comparing its results to the original validation and further exploring its clinimetric properties.

Methods: The scale underwent translation, back-translation, and cognitive pretesting before being administered to a calculated sample of > 200 PD patients. Each patient was assessed using a set of validated measures for assessing PD and cognitive state. We explored NoMoFA's feasibility, acceptability, factorial structure, internal consistency, convergent validity, test-retest reliability (the latter performed on 50 patients after 14 days), and the precision of the scale.

Results: 227 PD patients (mean age 65.34, disease duration 9.31 years) were included, with 100% data computability. The scale was free from floor and ceiling effects, and included 7 factors (59.2% of the variance). Cronbach's alpha coefficient was 0.89, indicating strong internal consistency. The intraclass correlation coefficient (ICC) of 0.90 demonstrated satisfactory reproducibility. The NoMoFA Total score showed the strongest correlations with MDS-UPDRS Parts I (rS = 0.71) and II (rS = 0.60). Significant differences in NoMoFA scores were observed based on disease duration, H&Y score, and LEDD (p < 0.0001), but not age or sex. The Standard error of measurement (SEM) was 3.40 (for ½ SDpooled = 5.48).

Conclusion: The Italian version of the NoMoFA scale demonstrated strong reliability, validity and precision, making it a robust tool for assessing non-motor fluctuations in PD.

Keywords: Italian version; Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire; Non-motor fluctuations (NMF); Non-motor symptoms (NMS); Parkinson’s disease (PD).

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Conflict of interest statement

Declarations. Conflict of interests: Roberta Balestrino: no relevant financial or non-financial interests to disclose. Domiziana Rinaldi: no relevant financial or non-financial interests to disclose. Silvia Galli: no relevant financial or non-financial interests to disclose. Alberto Romagnolo: no relevant financial or non-financial interests to disclose. Roberto Erro: no relevant financial or non-financial interests to disclose. Claudia Ledda: no relevant financial or non-financial interests to disclose. Giulia Donzuso: no relevant financial or non-financial interests to disclose. Marina Picillo: supports from the Italian Ministry of Health, the Italian Ministry of University and Fondazione della Società Italiana di Neurologia. Speaker honoraria from Abbvie. Claudio Terravecchia: no relevant financial or non-financial interests to disclose. Federica Agosta is Associate Editor of NeuroImage: Clinical, has received speaker honoraria from Biogen Idec, Italfarmaco, Roche, Zambon and Eli Lilly, and receives or has received research supports from the Italian Ministry of Health, the Italian Ministry of University and Research, AriSLA (Fondazione Italiana di Ricerca per la SLA), the European Research Council, the EU Joint Programme – Neurodegenerative Disease Research (JPND), and Foundation Research on Alzheimer Disease (France). Paolo Barone: research grant from M.J. Fox Foundation; Advisory Board of: Roche, UCB, Abbvie, Zambon, Bial, Chiesi. Leonardo Lopiano: speech honoraria from Zambon, Bial, Abbvie, UCB. Alessandra Nicoletti: no relevant financial or non-financial interests to disclose. Massimo Filippi is Editor-in-Chief of the Journal of Neurology, Associate Editor of Human Brain Mapping, Neurological Sciences, and Radiology; received compensation for consulting services from Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi; speaking activities from Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and TEVA; participation in Advisory Boards for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda; scientific direction of educational events for Biogen, Merck, Roche, Celgene, Bristol-Myers Squibb, Lilly, Novartis, Sanofi-Genzyme; he receives research support from Biogen Idec, Merck-Serono, Novartis, Roche, the Italian Ministry of Health, the Italian Ministry of University and Research, and Fondazione Italiana Sclerosi Multipla. Pablo Martinez-Martin: no relevant financial or non-financial interests to disclose. Carlo Alberto Artusi: speech honoraria from Zambon, Bial, Abbvie, Lusofarmaco. No conflict of interest. Ethical approval: Approval from the independent Research Ethics Committee of each hospital was also obtained. The study was registered in clinicaltrials.gov (n°NCT06406374). All the participants gave their written informed consent prior to enrollment.

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