Full length articleA “HOLTER” for Parkinson’s disease: Validation of the ability to detect on-off states using the REMPARK system
Introduction
Parkinson’s disease (PD) is complicated over time by both motor complications (MCs) [1] and non-motor complications (NMCs) [2] in the vast majority of patients. Symptomatic control of MCs can be challenging and requires frequent adjustment of therapy on account of unpredictable therapeutic responses. Treatment is principally aimed at reducing the time during which the patient is in the OFF state, while avoiding the appearance of MCs and NMCs, including hallucinations and/or impulse control disorders [2]. The reduction of OFF time is therefore one of the main parameters used to evaluate the effectiveness of therapeutic interventions, both in medical practice and in clinical trials. Gathering accurate information about a patient's condition throughout the day is essential to plot the optimal treatment plan. In clinical practice, the only method currently available is based on diaries filled in by patients and their caregivers, recording hours of ON-OFF and the presence of dyskinesias [3]. However, this method has limitations that make it unreliable, such as motor and cognitive difficulties impeding the ability to complete the diary, and the subjective nature of the self-evaluation [4]. Hence, there is considerable research interest in potential solutions that can improve disease management [5], [6], [7], [8]. Wearable inertial sensors based on micro-electro-mechanical systems such as accelerometers and gyroscopes, have been widely used to analyse symptoms of PD such as tremor, bradykinesia, or dyskinesia; these sensors have enhanced attempts to provide objectivity in the assessment of these symptoms. Some studies have examined the monitoring of motor states, but the results demonstrated only modest sensitivity and specificity [9], [10], [11]. Other studies used more than one sensor [12], [13], [14], [15], [16], resulting in less comfort for the patient. Moreover, monitoring was performed in controlled clinical environments, where conditions are different to patients’ daily life [17]. The REMPARK system (REMPARK Personal health device for the remote and autonomous management of Parkinson’s disease, FP7 project REMPARK ICT-287677) is a wearable system, developed between 2011 and 2015, which aims to monitor motor states through a system requiring a single sensor (Fig. 1). The system has three main components: a wearable inertial sensor housed in a bio-compatible belt; a smartphone with specifically developed applications which sends the gathered information to the cloud; and the Disease Management Application (DMA) to display the stored data. Analogous to the “Holter” for the monitoring of cardiac parameters, the REMPARK System is designed to record the patient's condition during daylight hours and to aid in managing the disease via the smartphone. Its specifically developed applications send external cues to improve walking, or invite the patient to fill out a questionnaire for the control of NMS. The REMPARK System is also designed so health workers may manage the disease online.
The object of this study was to validate the REMPARK System as a system for automatic registration of ON-OFF fluctuations associated with PD treatment.
Section snippets
Subjects
A prospective pilot study was conducted, in which the recruitment was carried out following a convenience sampling among patients from the different centres participating in the REMPARK project: UParkinson-Teknon, (Barcelona, Spain), Fondazione Santa Lucia (Rome, Italy), Maccabi Healthcare-Services (Tel Aviv, Israel) and the National University of Ireland Galway (Galway, Ireland). The investigation was conducted in accordance with the Helsinki declaration 1964 (2008 Revision) and Good Clinical
Results
Fifty-four patients were initially contacted, 44 of whom met inclusion criteria and agreed to participate. Three of these patients did not complete the study procedure: one of them discontinued participation voluntarily and the other two were removed from the study by the researchers. The first due to lack of adherence to the study protocol and the second due to a health condition which required hospitalisation, not related to study devices or procedures. Forty-one patients completed the study
Discussion
Systems that monitor PD symptoms reliably and accurately can be very useful in optimising treatment in patients. By knowing how the motor state changes during the day when a drug is administered, the dosage may be adjusted more accurately. Our study evaluated the accuracy of the REMPARK system for monitoring ON-OFF states in Parkinson’s patients in real conditions.
Despite the widespread use of patient diaries both in clinical practice and research settings for monitoring motor function, their
Conclusions
The current management of advanced PD is complicated. There is a need for a reliable tool to detect a patient's motor-state, in order to adjust therapy. This paper has presented the validation of the REMPARK system for detecting the ON-OFF states with a high degree of accuracy.
The reliable detection of the motor state of PD patients throughout the day can dramatically change the value of clinical drug trials. Furthermore, it allows for individual adjustment of symptomatic treatment with a high
Conflict of interest statement
We have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. This work submitted to Gait & Posture complies with the principles laid down in the Declaration of Helsinki. We confirm that the work has been approved by the appropriate ethical committees related to the institution(s) in which it was performed and that subjects gave informed consent to the work. Each of the authors has read and concurs with the content
Funding sources and conflict of interest
This work has been performed in the framework of the FP7 project REMPARK ICT-287677, which is funded by the European Community. The authors would like to acknowledge the contributions of their colleagues from REMPARK Consortium. There are no potential conflicts of interest to report.
Financial disclosures for the previous 12 months
No financial relationships are relevant to this manuscript.
Ethical compliance statement
We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines.
Author roles
(1) Research project: A. Conception, B. Organization, C. Execution; (2) Statistical Analysis: A. Design, B. Execution, C. Review and Critique; (3) Manuscript: A. Writing of the first draft, B. Review and Critique.
A.B.: 1A, 1B, 1C, 2A, 2B, 2C, 3A, 3B; A.S.: 1A, 1B, 1C, 2A, 2B, 2C, 3A, 3B; A.P.: 1A, 2A, 2C, 3A, 3B; C.P.-L.: 1A, 1B, 1C, 2A, 2B, 2C, 3A, 3B; M.C.-M.: 1A, 2A, 2B, 2C, 3B; J.M.M.: 1B, 1C, 3B; S.A.: 1C; A.R.-M.: 2A, 2B, 2C; B.M.: 1C; P.Q.: 1C; A.C.: 1B, 1C, 3B; R.A.: 1B, 1C, 3B; P.B.:
Acknowledgments
The authors would like to acknowledge all patients who participated in the pilots for their excellent and generous collaboration. We would like to acknowledge the contributions of colleagues from REMPARK Consortium.
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