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. 2021 Jul 19;11(7):e045272.
doi: 10.1136/bmjopen-2020-045272.

Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods: study protocol

Alejandro Rodríguez-Molinero  1 , Jorge Hernández-Vara  2 , Antonio Miñarro  3 , Carlos Pérez-López  4 , Àngels Bayes-Rusiñol  5 , Juan Carlos Martínez-Castrillo  6 , David A Pérez-Martínez  7 ; Monitoring Parkinson’s patients Mobility for therapeutic purposes research group
Collaborators, Affiliations

Multicentre, randomised, single-blind, parallel group trial to compare the effectiveness of a Holter for Parkinson's symptoms against other clinical monitoring methods: study protocol

Alejandro Rodríguez-Molinero et al. BMJ Open. .

Abstract

Introduction: In recent years, multiple studies have aimed to develop and validate portable technological devices capable of monitoring the motor complications of Parkinson's disease patients (Parkinson's Holter). The effectiveness of these monitoring devices for improving clinical control is not known.

Methods and analysis: This is a single-blind, cluster-randomised controlled clinical trial. Neurologists from Spanish health centres will be randomly assigned to one of three study arms (1:1:1): (a) therapeutic adjustment using information from a Parkinson's Holter that will be worn by their patients for 7 days, (b) therapeutic adjustment using information from a diary of motor fluctuations that will be completed by their patients for 7 days and (c) therapeutic adjustment using clinical information collected during consultation. It is expected that 162 consecutive patients will be included over a period of 6 months.The primary outcome is the efficiency of the Parkinson's Holter compared with traditional clinical practice in terms of Off time reduction with respect to the baseline (recorded through a diary of motor fluctuations, which will be completed by all patients). As secondary outcomes, changes in variables related to other motor complications (dyskinesia and freezing of gait), quality of life, autonomy in activities of daily living, adherence to the monitoring system and number of doctor-patient contacts will be analysed. The noninferiority of the Parkinson's Holter against the diary of motor fluctuations in terms of Off time reduction will be studied as the exploratory objective.Ethics and dissemination approval for this study has been obtained from the Hospital Universitari de Bellvitge Ethics Committee. The results of this study will inform the practical utility of the objective information provided by a Parkinson's Holter and, therefore, the convenience of adopting this technology in clinical practice and in future clinical trials. We expect public dissemination of the results in 2022.

Trial registration: NCT04176302; https://clinicaltrials.gov/show/NCT04176302.

Keywords: Parkinson's disease; clinical trials; neurology.

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Conflict of interest statement

Competing interests: AR-M and CP-L are shareholders of Sense4Care, the company that will market the tested device in the short term. AR-M participated with other authors in obtaining funding for the study and in the protocol design. Given his conflict of interest, he will manage the project as the sponsoring centre’s coordinator but will not participate in the data collection, study monitoring, statistical analysis or interpretation of results. CP-L only contributed to study logistics preparation, including software for managing Parkinson’s Holter data during the trial.

Figures

Figure 1
Figure 1
Parkinson’s Holter.
Figure 2
Figure 2
Parkinson’s Holter summary data table.
Figure 3
Figure 3
Parkinson’s Holter weekly record.
Figure 4
Figure 4
Page 1 of the diary of motor fluctuations.
See this image and copyright information in PMC

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