Background: In Parkinsonââ?¬â?¢s disease (PD), cognitive impairment is an important non-motor symptom heralding the\ndevelopment of dementia. Effective treatments to slow down the rate of cognitive decline in PD patients with mild\ncognitive impairment are lacking. Here, we describe the design of the Parkinââ?¬â?¢Play study, which assesses the effects\nof a cognitive health game intervention on cognition in PD.\nMethods/Design: This study is a multicentre, phase-II, open-randomized clinical trial that aims to recruit 222 PD\npatients with mild cognitive impairment. Eligible patients have PD, Hoehn & Yahr stages Iââ?¬â??III, are aged between 40\nand 75 years, and have cognitive impairment but no dementia. The intervention group (n = 111) will be trained\nusing a web-based health game targeting multiple cognitive domains. The control group (n = 111) will be placed\non a waiting list. In order to increase compliance the health game adapts to the subjectsââ?¬â?¢ performance, is enjoyable,\nand can be played at home. From each group, 20 patients will undergo fMRI to test for potential functional brain\nchanges underlying treatment. The primary outcome after 12 weeks of training is cognitive function, as assessed by\na standard neuropsychological assessment battery and an online cognitive assessment. The neuropsychological\nassessment battery covers the following domains: executive function, memory, visual perception, visuoconstruction\nand language. A compound score for overall cognitive function will be calculated as the mean score of all test Zscores\nbased on the distribution of scores for both groups taken together. Secondary outcomes at follow-up visits\nup to 24 weeks include various motor and non-motor symptoms, compliance, and biological endpoints (fMRI).\nDiscussion: This study aims at evaluating whether a cognitive intervention among PD patients leads to an\nincreased cognitive performance on targeted domains. Strengths of this study are a unique web-based health\ngame intervention, the large sample size, a control group without intervention and innovations designed to\nincrease compliance.
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