Effects of Cognitive Training on Everyday Cognitive and Brain Function in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Neuro-QoL CF v2 T-scores at 18 Weeks
研究概览
简要总结
The purpose of this research study is to determine whether cognitive training will improve cognitive and brain functions in people with Parkinson's Disease (PD) during activities of daily living using cognitive evaluations and magnetic resonance imaging (MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic PD
- •Age ≥ 40 years
- •Expected to be on a stable dopaminergic medication regimen throughout the study period
排除标准
- •Non-English speaking
- •Pregnancy
- •Breastfeeding
- •Excessive alcohol consumption (> 7 drinks per week for women, > 14 drinks per week for men) or illicit substance use
- •History of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than PD), or seizures
- •History of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive-compulsive disorder
- •History of head injury with loss of consciousness longer than a few minutes
- •Metallic surgical implants or traumatically implanted metallic foreign bodies
- •Inability to lie flat for about an hour in the MRI scanner
- •Discomfort being in small, enclosed spaces
- •Dementia at screening (Montreal Cognitive Assessment score < 21/30)
- •Cognitive problems in activities of daily living suggestive of more than mild cognitive impairment (PD Cognitive Functional Rating Scale > 4)
- •Mild cognitive impairment according to the Movement Disorders Society (MDS) Level II comprehensive assessment criteria (> 1.5 standard deviations below the norm in two tests in a single cognitive domain or in one test in two separate cognitive domains, with the exception that the executive domain scores can be up to 2 standard deviations below the norm)
- •Hoehn & Yahr stage > 3 (i.e., able to stand and walk, but not fully independent)
- •Focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism
- •Motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., MDS-Unified PD Rating Scale resting tremor score > 2 in limbs, head/chin tremor, or more than mild dyskinesia by history or exam)
结局指标
主要结局
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
时间窗: 18 weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Change in Quality of Life in Neurological Disorders Cognitive Function Version 2 (Neuro-QoL CF v2) T-scores at 6 Weeks
时间窗: Baseline and 6 weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
Change in Neuro-QoL CF v2 T-scores at 18 Weeks
时间窗: 18 weeks
Neuro-QoL CF v2 measures self-reported levels of cognitive functioning. Raw scores are converted to standardized T-scores (mean of 50 with a standard deviation of 10). Increase in T-scores from baseline indicates improvement in everyday cognitive functioning.
次要结局
- Change in Composite Executive Function T-scores at 6 Weeks(6 weeks)
- Change in Composite Executive Function T-scores at 18 Weeks(18 weeks)
- Change in Composite Executive Function T-scores at 6 Weeks(6 weeks)
- Change in Composite Executive Function T-scores at 18 Weeks(18 weeks)