van de Weijer Sjors C F, Duits Annelien A, Bloem Bastiaan R, Kessels Roy P, Jansen Jacobus F A, Köhler Sebastian, Tissingh Gerrit, Kuijf Mark L
Department of Neurology, Maastricht University Medical Center, Maastricht UMC+, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.
Department of Psychiatry and Psychology, Maastricht University Medical Center, Maastricht, The Netherlands.
BMC Neurol. 2016 Nov 3;16(1):209. doi: 10.1186/s12883-016-0731-z.
In Parkinson's disease (PD), cognitive impairment is an important non-motor symptom heralding the development of dementia. Effective treatments to slow down the rate of cognitive decline in PD patients with mild cognitive impairment are lacking. Here, we describe the design of the Parkin'Play study, which assesses the effects of a cognitive health game intervention on cognition in PD.
METHODS/DESIGN: This study is a multicentre, phase-II, open-randomized clinical trial that aims to recruit 222 PD patients with mild cognitive impairment. Eligible patients have PD, Hoehn & Yahr stages I-III, are aged between 40 and 75 years, and have cognitive impairment but no dementia. The intervention group (n = 111) will be trained using a web-based health game targeting multiple cognitive domains. The control group (n = 111) will be placed on a waiting list. In order to increase compliance the health game adapts to the subjects' performance, is enjoyable, and can be played at home. From each group, 20 patients will undergo fMRI to test for potential functional brain changes underlying treatment. The primary outcome after 12 weeks of training is cognitive function, as assessed by a standard neuropsychological assessment battery and an online cognitive assessment. The neuropsychological assessment battery covers the following domains: executive function, memory, visual perception, visuoconstruction and language. A compound score for overall cognitive function will be calculated as the mean score of all test Z-scores based on the distribution of scores for both groups taken together. Secondary outcomes at follow-up visits up to 24 weeks include various motor and non-motor symptoms, compliance, and biological endpoints (fMRI).
This study aims at evaluating whether a cognitive intervention among PD patients leads to an increased cognitive performance on targeted domains. Strengths of this study are a unique web-based health game intervention, the large sample size, a control group without intervention and innovations designed to increase compliance.
NTR5637 on 7-jan-2016.
在帕金森病（PD）中，认知障碍是预示痴呆发生的重要非运动症状。目前缺乏有效治疗来减缓轻度认知障碍的PD患者认知衰退的速度。在此，我们描述了Parkin'Play研究的设计，该研究评估一种认知健康游戏干预对PD患者认知的影响。
方法/设计：本研究是一项多中心、II期、开放随机临床试验，旨在招募222例轻度认知障碍的PD患者。符合条件的患者患有PD，Hoehn & Yahr分期为I - III期，年龄在40至75岁之间，有认知障碍但无痴呆。干预组（n = 111）将使用一款针对多个认知领域的基于网络的健康游戏进行训练。对照组（n = 111）将被列入等待名单。为了提高依从性，该健康游戏会根据受试者的表现进行调整，具有趣味性且可在家中进行。每组将有20名患者接受功能磁共振成像（fMRI）检查，以测试治疗潜在的脑功能变化。训练12周后的主要结局是认知功能，通过标准神经心理评估量表和在线认知评估进行评估。神经心理评估量表涵盖以下领域：执行功能、记忆、视觉感知、视觉构建和语言。将根据两组得分分布计算所有测试Z分数的平均分作为总体认知功能的复合分数。随访至24周的次要结局包括各种运动和非运动症状、依从性以及生物学终点（fMRI）。
本研究旨在评估PD患者的认知干预是否会使目标领域的认知表现提高。本研究的优势在于独特的基于网络的健康游戏干预、大样本量、无干预的对照组以及旨在提高依从性的创新设计。
2016年1月7日注册，注册号为NTR5637。
