The Parkin'Play study: Protocol of a phase II randomized controlled trial to assess the effects of a health game on cognition in Parkinson's disease

Autor: Gerrit Tissingh, Sjors C.F. van de Weijer, Jacobus F.A. Jansen, Bastiaan R. Bloem, Roy P. C. Kessels, Annelien Duits, Mark L. Kuijf, Sebastian Köhler
Přispěvatelé: Promovendi MHN, Klinische Neurowetenschappen, MUMC+: MA Niet Med Staf Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Niet Med Staf Psychologie (9), Beeldvorming, MUMC+: DA BV Klinisch Fysicus (9), Psychiatrie & Neuropsychologie, MUMC+: MA Med Staf Spec Neurologie (9)
Rok vydání: 2016
Předmět:
Health game
Adult
medicine.medical_specialty
Alzheimer`s disease Donders Center for Medical Neuroscience [Radboudumc 1]
Clinical Neurology
Neuropsychological Tests
law.invention
03 medical and health sciences
Study Protocol
Executive Function
0302 clinical medicine
Randomized controlled trial
law
Memory
Medicine
Dementia
Humans
Cognitive Dysfunction
030212 general & internal medicine
Effects of sleep deprivation on cognitive performance
Neuropsychological assessment
Cognitive decline
Aged
Language
Cognitive Intervention
Neuro- en revalidatiepsychologie
medicine.diagnostic_test
business.industry
Neuropsychology and rehabilitation psychology
Mild cognitive impairment
Cognition
Parkinson Disease
General Medicine
Plasticity and Memory [DI-BCB_DCC_Theme 3]
Middle Aged
medicine.disease
Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3]
Cognitive functions
Clinical trial
Treatment Outcome
Video Games
Physical therapy
Visual Perception
Neurology (clinical)
business
030217 neurology & neurosurgery
RCT
Zdroj: BMC Neurology, 16
BMC Neurology
BMC Neurology, 16. BioMed Central Ltd
ISSN: 1471-2377
DOI: 10.1186/s12883-016-0731-z
Popis: Contains fulltext : 168194.pdf (Publisher’s version ) (Open Access) BACKGROUND: 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). DISCUSSION: 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. TRIAL REGISTRATION: NTR5637 on 7-jan-2016. 11 p.
Databáze: OpenAIRE
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