Beyond the Physical: Enhancing Psychosocial Functioning in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in working memory function between baseline and 10 weeks post training onset
研究概览
简要总结
This project will investigate the feasibility and preliminary effectiveness of an intensive and focused working memory training program for patients in the early stages of PD receiving dopaminergic therapy. The investigators hypothesize that working memory training will be an effective method of improving working memory and related cognitive and behavioural functions in PD patients.
详细描述
Parkinson's disease (PD) is not an exclusively motor disease; more than half of individuals with PD experience cognitive impairment even in the early stages of the disease and many develop dementia as the disease progresses. As a result, attention, memory, planning and organizational skills can be affected, interfering with everyday functioning (e.g. shopping, managing finances, job skills). Thus, interventions to improve cognitive abilities are needed to enhance psychosocial function and overall quality of life.
Some cognitive deficits, such as problems with working memory, are apparent even in the early stages of the disease. Working memory (WM) is the ability to actively maintain and manipulate information in one's mind and is needed for many complex tasks such as learning, communication and problem-solving . Individuals with PD often show deficits in both WM maintenance (e.g., holding a phone number in mind to make a call) and manipulation (e.g.,mental calculation at the grocery store checkout) skills, depending upon the stage of the disease and progression of damage to frontal-subcortical circuits. Attempts to identify pharmacological agents that ameliorate cognitive dysfunction have been largely unsuccessful or associated with undesirable side effects (e.g. Vale, 2009).
The investigators propose that specific cognitive training to improve WM could provide direct benefit to psychosocial function of PD patients; it could potentially enhance any positive benefits or reduce the negative effects of pharmacological treatment without an added risk of side effects as well. Promising interventions focused on intensive and direct WM training are emerging and have been shown to generalize to other cognitive domains, such as fluid intelligence.
Cognitive training has been successful in patients with traumatic brain injury, who also show WM deficits as a result of damage to frontal-subcortical circuits. In addition, successful WM training is associated with changes in dopamine receptor density as well as changes in patterns of neural activity in task-relevant areas of the brain. To date, a limited number of small group studies provide preliminary evidence that some aspects of cognitive function can be enhanced by training in PD patients also receiving dopaminergic therapy, although few use control groups to account for potential repeated testing practice effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •clinical diagnosis of idiopathic Parkinson's disease
- •self-reported concerns about their working memory, or working memory deficits that were identified by a clinical examination
- •be classified as Hohn & Yahr Stage 1 or 2
- •be receiving a stable dose of dopaminergic therapy
排除标准
- •presence of dementia or other significant neurological or psychiatric conditions, as determined by clinical history
- •Classification as Hohm & Yahr Stage 3 or 4
- •Not on a stable dos of dopaminergic therapy
研究组 & 干预措施
Early training group
The early training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. They will continue training on the adaptive working memory training task for 5 weeks, after which they will continue for 5 weeks using a non-adaptive working memory task (active control task).
干预措施: Adaptive working memory training task (Behavioral)
Early training group
The early training group will consist of 10 randomly assigned participants who will begin the adaptive working memory training task immediately after baseline assessment. They will continue training on the adaptive working memory training task for 5 weeks, after which they will continue for 5 weeks using a non-adaptive working memory task (active control task).
干预措施: Non-adaptive working memory training task (i.e. an active control task) (Behavioral)
Late training group
The late training group will consist of 10 randomly assigned participants who will engage in a non-adaptive working memory training task (i.e. an active control task) immediately after baseline assessment for 5 weeks. After the initial 5 weeks of the active control task they will then switch to the adaptive working memory task (the intervention) for 5 weeks. This is a randomized controlled cross-over design.
干预措施: Adaptive working memory training task (Behavioral)
Late training group
The late training group will consist of 10 randomly assigned participants who will engage in a non-adaptive working memory training task (i.e. an active control task) immediately after baseline assessment for 5 weeks. After the initial 5 weeks of the active control task they will then switch to the adaptive working memory task (the intervention) for 5 weeks. This is a randomized controlled cross-over design.
干预措施: Non-adaptive working memory training task (i.e. an active control task) (Behavioral)
No training group
The no training group will engage in no training over the course of the pilot study, but will still participate in baseline, 5 week, 10 . This will allow us to determine if changes in the outcome and assessment variables are due to the working memory training or progression in the disease itself.
干预措施: No training (Behavioral)
结局指标
主要结局
Change in working memory function between baseline and 10 weeks post training onset
时间窗: 10 weeks post training onset
Baseline Working memory function
时间窗: baseline
Working memory will be measured using the operation span task, the symmetry span task and the Sternberg memory scanning tasks. Operation span - This is a dual-task in which participants complete mathematical reasoning (e.g. solving a mathematical equation) while using short-term verbal memory to remember words. Symmetry span: This is a dual task in which participants discriminate about the symmetry of visual stimuli while using short-term spatial memory to remember the locations of stimuli. Sternberg memory scanning task - number memory test
Change in working memory function between baseline and 5 weeks post training onset
时间窗: 5 weeks post training onset
Change in working memory function between baseline and 22 weeks post training onset
时间窗: 22 weeks post training onset
次要结局
- change in fluid intelligence between baseline and 5 weeks post training onset(5 weeks post training onset)
- Baseline Executive functioning(Baseline)
- Change in executive functioning between baseline and 5 weeks post training onset(5 weeks post training onset)
- Change in fluid intelligence between baseline and 22 weeks post training onset(22 weeks post training onset)
- Change in executive functioning between baseline and 10 weeks post training onset(10 weeks post training onset)
- Baseline fluid intelligence(Baseline)
- Change in fluid intelligence between baseline and 10 weeks post training onset(10 weeks post training onset)
- Change in executive function between baseline and 22 weeks post training onset(22 weeks post training onset)
研究者
Gail Eskes
Dr. Gail Eskes
Nova Scotia Health Authority