Comparison of the Results of a Parkinson's Holter Monitor With Patient Diaries, in Real Conditions of Use: A Sub-analysis of the MoMoPa-EC Clinical Trial

Carlos Pérez-López, Jorge Hernández-Vara, Nuria Caballol, Àngels Bayes, Mariateresa Buongiorno, Núria Lopez-Ariztegui, Alexandre Gironell, José López-Sánchez, Juan Carlos Martínez-Castrillo, Alvarez Sauco M, Lydia López-Manzanares, Sonia Escalante-Arroyo, David A Pérez-Martínez, Alejandro Rodríguez-Molinero, MoMoPa-EC Research Group, Carlos Pérez-López, Jorge Hernández-Vara, Nuria Caballol, Àngels Bayes, Mariateresa Buongiorno, Núria Lopez-Ariztegui, Alexandre Gironell, José López-Sánchez, Juan Carlos Martínez-Castrillo, Alvarez Sauco M, Lydia López-Manzanares, Sonia Escalante-Arroyo, David A Pérez-Martínez, Alejandro Rodríguez-Molinero, MoMoPa-EC Research Group

Abstract

Background: For specialists in charge of Parkinson's disease (PD), one of the most time-consuming tasks of the consultations is the assessment of symptoms and motor fluctuations. This task is complex and is usually based on the information provided by the patients themselves, which in most cases is complex and biased. In recent times, different tools have appeared on the market that allow automatic ambulatory monitoring. The MoMoPa-EC clinical trial (NCT04176302) investigates the effect of one of these tools-Sense4Care's STAT-ON-can have on routine clinical practice. In this sub-analysis the agreement between the Hauser diaries and the STAT-ON sensor is analyzed.

Methods: Eighty four patients from MoMoPa-EC cohort were included in this sub-analysis. The intraclass correlation coefficient was calculated between the patient diary entries and the sensor data.

Results: The intraclass correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.73) for the OFF time (%), 0.48 (95% CI: 0.17-0.68) for the time in ON (%), and 0.65 (95% CI%: 0.44-0.78) for the time with dyskinesias (%). Furthermore, the Spearman correlations with the UPDRS scale have been analyzed for different parameters of the two methods. The maximum correlation found was -0.63 (p < 0.001) between Mean Fluidity (one of the variables offered by the STAT-dON) and factor 1 of the UPDRS.

Conclusion: This sub-analysis shows a moderate concordance between the two tools, it is clearly appreciated that the correlation between the different UPDRS indices is better with the STAT-ON than with the Hauser diary.

Trial registration: https://ichgcp.net/clinical-trials-registry/NCT04176302 (NCT04176302).

Keywords: Parkinson's disease; automatic ambulatory monitoring; motor fluctuations; therapeutic adjustment; wearable sensors.

Conflict of interest statement

CP-L, AR-M, JH-V, and ÀB were shareholder of Sense4Care the company that markets the tested device. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Pérez-López, Hernández-Vara, Caballol, Bayes, Buongiorno, Lopez-Ariztegui, Gironell, López-Sánchez, Martínez-Castrillo, Sauco M, López-Manzanares, Escalante-Arroyo, Pérez-Martínez, Rodríguez-Molinero and the MoMoPa-EC Research Group.

Figures

Figure 1
Figure 1
Diagram of the patient selection process for the subanalysis.

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