Plasticity of Motor Systems in Early Stage Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest
研究概览
简要总结
The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.
详细描述
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI), from Dr. Noam Harel's protocol IRB# STUDY00008096, and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. The TMS experiment will use a Magstim Bistimn 2002 transcranial magnetic stimulation (TMS) unit and standard figure-of-eight coil (70 mm diameter) to deliver stimulation on the surface of the scalp. Stimulation will be delivered using either a single pulse or with a paired-pulse protocol (two stimuli, through the same TMS coil at inter-stimulus intervals of 50 or 80 ms). All surface EMG signals will be pre-amplified within the sensor and sent wirelessly via blue-tooth connection to a Delsys data collection system. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function will used to assess behavioral status at baseline and 30-36 months later.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with PD
- •Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria
- •Not receiving levodopa or dopamine agonist to treat PD (at baseline)
- •Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters Healthy Controls
- •Age- (+/- 3 years) and sex-matched to participants with PD
- •Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters
排除标准
- •Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent
- •History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment
- •History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
- •Other significant neurological disorders that may affect participation or performance in the study
- •Implanted DBS or other neurosurgeries to treat PD
- •Pregnancy
- •Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):
- •History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
- •Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.
- •Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
- •Pacemaker or any implanted device
- •History of surgery on blood vessels, brain, or heart
- •Unexplained, recurring headaches or concussion within the last six months
- •Severe hearing impairment
研究组 & 干预措施
Healthy Controls
Age- and sex-matched healthy controls.
干预措施: Neuroimaging (Diagnostic Test)
Healthy Controls
Age- and sex-matched healthy controls.
干预措施: Quantitative assessments (Diagnostic Test)
Early (untreated) Parkinson's Disease
Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
干预措施: Neuroimaging (Diagnostic Test)
Early (untreated) Parkinson's Disease
Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
干预措施: Quantitative assessments (Diagnostic Test)
结局指标
主要结局
Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest
时间窗: Baseline, 30-36 months
Change in volume of Subthalamic Nucleus
时间窗: Baseline, 30-36 months
The volume of the subthalamic nucleus is assessed using MRI and reported in millimeters cubed (mm\^3).
Change in Mattis Dementia Rating Scale 2 (DRS-2)
时间窗: Baseline, 30-36 months
The DRS-2 consists of 24 items, rated on a scale from 0 to 6. Item scores are combined into five subscales: attention (8 items), initiation/perseveration (11 items), construction (6 items), conceptualization ( 6 items), and memory (5 items). These five subscale scores are summed to calculate a total score ranging from from 0 to 144 points, with lower scores indicating worse performance due to dementia.
Change in Brief Visuospatial Memory Test - Revised (BVMT-R)
时间窗: Baseline, 30-36 months
Change in paired Associative Stimulation-Motor Evoked Potential (PAS-MEP)
时间窗: Baseline, 30-36 months
Motor evoked potential is measured as the amplitude of change in target muscle electrical activity following transcranial magnetic stimulation (TMS) and reported in units of millivolts (mV).
Change in Rey Complex Figure and Matrix Reasoning of the Wechsler Adult Intelligence Scale - IV
时间窗: Baseline, 30-36 months
Change in Stroop Color Word Test
时间窗: Baseline, 30-36 months
Change in cortico-STN Connectivity
时间窗: Baseline, 30-36 months
Cortico-Subthalamic nucleus connectivity is measured using MRI and reported as a z score (unitless).
Change in Wisconsin Card Sorting Test
时间窗: Baseline, 30-36 months
Change in fractional Anisotropy of Subthalamic Nucleus
时间窗: Baseline, 30-36 months
Fractional anisotropy, measured using MRI, is a unit-less value between zero and one that describes the degree of anisotropy of water diffusion in a specified brain area. Higher values indicate a greater degree of anisotropy, while a score of zero indicates isotropic diffusion.
次要结局
未报告次要终点