Development and Evaluation of a Novel Treatment Intervention for People With Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment Process.
研究概览
简要总结
There is a pressing need to develop more effective interventions to remediate cognitive deficits in highly prevalent disabling conditions such as stroke, head injury and other forms of acquired brain injury (ABI). Neuropsychological rehabilitation interventions developed in a clinical setting have shown some beneficial effects, but the effectiveness of clinical interventions have potential to be enhanced if informed by findings from cognitive neuroscience. Research into cognitive training using methods such as functional magnetic resonance imaging (fMRI) has contributed to an understanding of factors that promote changes in brain function, but this approach seldom includes individuals with brain damage or cognitive deficits. Its potential for application with clinical populations is therefore uncertain, meaning that people who may benefit do not have access to interventions that may improve their health and wellbeing.
The proposed research brings together methods from neuropsychological rehabilitation and cognitive neuroscience to investigate 1) the feasibility of, and effect sizes arising from, combining an existing clinical intervention targeting mental strategies with an adaptive training programme targeting core cognitive processes, and 2) whether the novel treatment combination promotes changes in brain function that are detectable using fMRI.
This project will develop and evaluate a training intervention that aims to improve outcomes from a strategy-based rehabilitation intervention, Goal Management Training (GMT), by adding process-based cognitive training with adaptive difficulty to enhance the executive function of working memory updating (WMU). People with ABI (n=32) will complete 9 sessions of GMT, a recommended treatment for deficits in frontal-lobe executive functions, with the addition of 8 WMU training sessions with or without adaptive training. Measures of feasibility, acceptability, and fidelity will be taken, and effect sizes of differences in pre- to post-training changes on neural, cognitive, and functional measurements will be determined by comparing two experimental groups in which difficulty of the WMU training tasks either adaptively increases in response to performance or is fixed.
详细描述
Globally, stroke and head injury are leading causes of disability. Deficits in cognitive functions are common in these conditions, including impairment in frontal-lobe 'executive' functions such as working memory and the ability to solve problems, plan, and regulate actions in order to achieve intended goals. These deficits affect individuals' ability to live independently, work, and maintain social relationships. We propose that improving outcomes for people with acquired brain injury (ABI) requires an interdisciplinary approach in which neuropsychological rehabilitation and cognitive neuroscience complement one another.
In neuropsychological rehabilitation, interventions are classified as 'restorative' (restoration of underlying core cognitive processes including executive functions) or 'compensatory' (compensation of function through the use of external aids or learned strategies). Clinical guidelines recommend the use of 'meta-cognitive strategy training' for the treatment of deficits in frontal-lobe executive functions. Goal Management Training (GMT) is one such validated meta-cognitive strategy. GMT trains compensatory mental strategies to manage attention during multi-step tasks. GMT has been evaluated behaviourally in randomised controlled trials with positive, albeit modest, outcomes in individuals with ABI.
In cognitive neuroscience, an emerging research area concerns experience-induced neural changes referred to as neural plasticity. These may involve neural changes in: 1) task-based functional activation patterns, i.e. activity increases, decreases, or reorganisation, 2) brain structure, i.e., grey matter and white matter volume changes and 3) functional connectivity, i.e. changes in connectivity between brain regions that are recruited for a mental procedure as well as changes in the strength and magnitude.
Neuroimaging studies have demonstrated that programmes to train core cognitive processes including working memory (WM) executive functions can drive changes both in behavioural and neural measures. Performance gains after process-based training have been observed by several authors employing different training tasks and including both younger and older populations. In addition, generalisation to broad cognitive abilities such as reasoning, episodic memory, after process-based training, has been observed in both young and older adults although this area is under debate. This work has primarily involved healthy adults and whether the same findings apply to those with ABI needs to be investigated.
This research study aims to develop and evaluate a novel treatment intervention for people with ABI that combines a process-based cognitive training with a strategy-based GMT rehabilitation intervention, and to acquire functional magnetic resonance imaging (fMRI) data before and after the intervention to measure patterns of brain activity associated with a task requiring executive functions. We propose that outcomes from GMT might be improved by an adaptive, process-based intervention aimed at enhancing working memory processes. Adaptive task difficulty involves dynamic adjustment of training task demands so that the individual remains within an optimal range of performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only those able to give informed consent and able to comply with the training protocol will be included.
- •≥ 6 months post-ABI at time of recruitment (expression of interest to participate either verbally or in writing)
- •Adults over the age of
- •English language fluency (speaking)
- •a combination of self/relative/friend/carer reports of everyday organisation/memory problems
排除标准
- •Individuals with contra-indications to MRI (e.g. heart pacemaker)
- •Comorbid progressive neurological disorder or neurodegenerative condition (e.g. dementia)
- •Major psychiatric disorder considered likely to prevent engagement in the intervention programme (pre-ABI history of mood disorder or stable antidepressant medication will not lead to exclusion)
- •History of major substance abuse problems likely to prevent engagement in the intervention programme
- •Unable to give informed consent
- •Unable to cooperate with the study protocol (e.g. severe impairment of hearing, vision or language)
结局指标
主要结局
Feasibility of Recruitment Process.
时间窗: From pre-intervention (Week 1) to post-intervention (Week 12).
Number of people referred from NHS eligible for screening and those entering the intervention. This will be continuously monitored throughout the study period.
Participants' Drop-out Rates
时间窗: From pre-intervention (Week 1) to post-intervention (Week 12).
Number of people completing the intervention to assess drop-out rates. This will be continuously monitored throughout the study period.
Participants' Coherence and Adherence to the Intervention.
时间窗: From pre-intervention (Week 1) to post-intervention (Week 12).
Mean percentage of working memory training sessions completed (a total of eight) were calculated across participants.
Feedback Questionnaire
时间窗: Post-intervention session (Week 12)
Participant evaluation of the intervention using a study-specific questionnaire including eight 5-point Likert-scale agreement questions (scores of 1 to 5 with 1 being positive and 5 being negative). Mean feedback score was calculated across participants.
次要结局
- Visuospatial Working Memory Using the Visuospatial Matrix Updating fMRI Task(Post-intervention session (week 12))
- Visuospatial Working Memory fMRI Task Accuracy Using the Spatial N-back fMRI Task(Post-intervention session (Week 12))
- Episodic Visual Memory Accuracy Using the Object-location Association fMRI Task.(Post-intervention session (Week 12))
- Changes in Shifting Attention Using the Intra-Extra Dimensional Set Shift Test Variant From CANTAB Connect Research Web-testing.(Pre-intervention (Week 1) and post-intervention (Week 12))
- Changes in Spatial Planning and Problem Solving Using the Stockings of Cambridge Test Variant From CANTAB Connect Research Web-testing.(Pre-intervention (Week 1) and post-intervention (Week 12))
- Changes in Spatial Working Memory Using the Spatial Working Memory Test Variant From CANTAB Connect Research Web-testing.(Pre-intervention (Week 1) and post-intervention (Week 12))
- Changes in Visuospatial Working Memory Using the Spatial Span Forward Test Variant From CANTAB Connect Research Web-testing.(Pre-intervention (Week 1) and post-intervention (Week 12))
- Changes in Visuospatial Working Memory Using the Spatial Span Reverse Test Variant From CANTAB Connect Research Web-testing.(Pre-intervention (Week 1) and Post-intervention (Week 12))