Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease: A Functional MRI Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex.
研究概览
简要总结
Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals with Parkinson's Disease: A functional MRI investigation.
详细描述
This project will examine the effect of functional MRI-based neurofeedback on brain plasticity and motor performance in patients with Parkinson's Disease (PD).
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)
盲法说明
double blinded
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
- •Subjects with a diagnosis of idiopathic PD defined according to the UK Brain Bank diagnostic criteria and on a stable dopaminergic medication regimen will be included.
排除标准
- •Age < 40 years
- •Non-English speaking
- •Pregnancy
- •Breastfeeding
- •Excessive alcohol consumption (> 7 drinks per week for women, > 14 drinks per week for men) or 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
- •Metallic surgical implants or traumatically implanted metallic foreign bodies
- •Inability to lie flat for about an hour
- •Discomfort being in small, enclosed spaces
- •Dementia (Montreal Cognitive Assessment score < 21)
- •Depression (Beck Depression Inventory-II score > 19)
- •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-UPDRS resting tremor score > 1 in limbs, head/chin tremor, or dyskinesia by history or exam).
结局指标
主要结局
Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex.
时间窗: 4-6 weeks
We will obtain resting-state functional MRI scans from the PD-neurofeedback and PD-control groups at baseline and post-intervention to examine the changes in intrinsic functional connectivity between the right insula and dorsomedial frontal cortex. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions.
Change in Motor Impairment
时间窗: Baseline and 4-6 weeks
We will administer the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor exam) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor impairment. The MDS-UPDRS part III is a subscale that provides an objective assessment of motor impairment. The scores range between 0-132. Higher scores indicate more severe impairment.
Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength.
时间窗: 4-6 weeks
The functional connectivity strength between the subjects' right insula and dorsomedial frontal cortex will be measured at baseline and post-intervention as each group of subjects engages in their respective imagery tasks. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions.
Change in Motor Function
时间窗: Baseline and 4-6 weeks
We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 360-degree turn) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor function. The performance score on these tests is the time to complete the motor tasks. Shorter time indicates better performance. The motor function tests measure movement speed. Timed up and go test measures (seconds) how fast one can stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down again. Five times sit-to-stand test measures (seconds) how fast one can stand up from a chair with arms crossed across the chest and sit back again 5 times in a row. 360-degree turn test measures (seconds) how fast one can turn around their own axis clockwise and counterclockwise. The composite motor function score is the sum of the durations (seconds) of all three tests.
次要结局
未报告次要终点