期刊
PARKINSONISM & RELATED DISORDERS
卷 44, 期 -, 页码 124-128出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.parkreldis.2017.08.010
关键词
Hypokinesia; Night-time; Parkinson's disease; Rotigotine; Wearable technology; Inertial sensors
资金
- National Research Council of Thailand [GRB_APS_05_59_30_04]
- Health System Research Institute of Thailand Fund [59-012]
- International Research Network grant [RDG5950152]
- Chulalongkorn Academic Advancement Fund into Its 2nd Century Project of Chulalongkorn University, Bangkok, Thailand
Background: Nocturnal hypokinesia is a common symptom in Parkinson's disease (PD), negatively affecting quality of life of both patients and caregivers. However, evidence-based treatment strategies are limited. Objective: To evaluate the efficacy of rotigotine transdermal patch, using a wearable sensor, in the management of nocturnal immobility. Methods: 34 PD subjects with nocturnal immobility were randomized to receive rotigotine transdermal patch (mean +/- SD of 10.46 +/- 4.63 mg/24 h, n = 17) or placebo patch (n = 17). Treatment was titrated to an optimal dose over 1-8 weeks, then maintained for 4 weeks. Primary endpoints were objective parameters assessing axial rotation measured using an axial inertial sensor (the NIGHT-Recorder) over two nights at the patients' home. Scale-based assessments were also performed. Results: There was a significant difference, in favor of rotigotine, in change from baseline score in the number of turns in bed (ANCOVA, p = 0.001), and degree of axial turn (p = 0.042). These objective improvements were mirrored by significantly greater improvements in clinical scale-based assessments, including the Unified Parkinson's Disease Rating Scale (UPDRS) total scores (p = 0.009), UPDRS-motor scores (p < 0.001), UPDRS-axial scores (p = 0.01), the Modified Parkinson's Disease Sleep Scale (p < 0.001), the Nocturnal Akinesia Dystonia and Cramp Scale (p = 0.003) and the eight-item PD Questionnaire (PDQ-8) scores (p = 0.01) from baseline to end of treatment in patients given rotigotine compared to placebo. Conclusion: We show that the rotigotine patch provides a significant improvement in nocturnal symptoms as assessed using both objective measures and clinical rating scales. The study demonstrates the feasibility of using wearable sensors to record objective outcomes in PD-related clinical trials. (C) 2017 Elsevier Ltd. All rights reserved.
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