Yhnell Emma, Furby Hannah, Breen Rachel S, Brookes-Howell Lucy C, Drew Cheney J G, Playle Rebecca, Watson Gareth, Metzler-Baddeley Claudia, Rosser Anne E, Busse Monica E
1Neuroscience and Mental Health Research Institute, Cardiff University, 3rd Floor, Hadyn Ellis Building, Maindy Road, Cardiff, CF24 4HQ Wales UK.
2Cardiff University Brain Research Imaging Centre (CUBRIC), School of Psychology, Cardiff University, Maindy Road, Cardiff, CF24 4HQ Wales UK.
Pilot Feasibility Stud. 2018 Feb 6;4:45. doi: 10.1186/s40814-018-0237-0. eCollection 2018.
Cognitive impairments, especially deficits of executive function, have been well documented as a core and early feature in Huntington's disease (HD). Cognitive impairments represent considerable burden and can be devastating for people and families affected by HD. Computerised cognitive training interventions that focus on improving executive function present a possible non-pharmacological treatment option. We propose to determine the feasibility, acceptability, and appropriate outcome measures for use in a randomised controlled feasibility study.
METHODS/DESIGN: Participants will be randomised into either a computerised cognitive training group or a control group. Those randomised to the training group will be asked to complete a cognitive training intervention based on the HappyNeuron Pro software tasks of executive function, for a minimum of 30 min, three times a week for the 12-week study duration. Participants in the control group will not receive computerised cognitive training but will receive a similar degree of social interaction via equivalent study and home visits. We will explore quantitative outcome measures, including measures of cognitive performance, motor function, questionnaires and semi-structured interviews, as well as magnetic resonance imaging (MRI) measures in a subset of participants. Feasibility will be determined through assessment of recruitment, retention, adherence and acceptability of the intervention.
The results of this study will provide crucial guidance and information regarding the feasibility of conducting a randomised controlled study into computerised cognitive training in HD. This study is crucial for the development of larger definitive randomised controlled trials which are powered to determine efficacy and for the development of future cognitive training programmes for people affected by HD.
The study is registered on clinicaltrials.gov and has the unique identifier NCT02990676.
认知障碍，尤其是执行功能缺陷，已被充分证明是亨廷顿舞蹈症（HD）的核心和早期特征。认知障碍带来了相当大的负担，对HD患者及其家庭可能是灾难性的。专注于改善执行功能的计算机化认知训练干预提供了一种可能的非药物治疗选择。我们建议确定在一项随机对照可行性研究中使用的可行性、可接受性和适当的结果测量方法。
方法/设计：参与者将被随机分为计算机化认知训练组或对照组。随机分配到训练组的参与者将被要求基于HappyNeuron Pro软件的执行功能任务完成认知训练干预，每次至少30分钟，在为期12周的研究期间每周进行三次。对照组的参与者不会接受计算机化认知训练，但将通过同等的研究和家访获得类似程度的社交互动。我们将探索定量结果测量方法，包括认知表现、运动功能测量方法、问卷调查和半结构化访谈，以及对一部分参与者进行磁共振成像（MRI）测量。可行性将通过评估干预的招募、保留、依从性和可接受性来确定。
本研究的结果将为开展HD计算机化认知训练的随机对照研究的可行性提供关键指导和信息。这项研究对于开展更大规模的确定性随机对照试验（以确定疗效）以及为HD患者开发未来的认知训练计划至关重要。
该研究已在clinicaltrials.gov上注册，唯一标识符为NCT02990676。
