Neural Mechanisms Underlying the Benefits of Aerobic Exercise in Advanced Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)
研究概览
简要总结
This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.
详细描述
This study is investigating how aerobic exercise, specifically forced exercise (FE) and voluntary exercise (VE), affects movement, thinking, and brain activity in people with advanced Parkinson's disease who have deep brain stimulation (DBS). Over eight weeks, 36 participants will complete either a forced cycling program (where a motor helps them pedal faster than they could on their own) or a voluntary cycling program at a self-driven pace. Participants will complete an 8-week delayed start period to serve as a comparison before starting an exercise program.
The study will measure motor symptoms, cognitive performance, and brain activity from both the cortex (via EEG) and the subthalamic nucleus (via DBS device recordings) at several time points, including before treatment, after the 8-week exercise period, and again four weeks later. By analyzing how neural signals change at rest and during tasks, the study will evaluate the neural mechanisms that make exercise beneficial. This research could ultimately guide more effective, personalized exercise therapies to support people with advanced Parkinson's disease with DBS.
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
- Single (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 Parkinson's disease
- •Previous placement of bilateral Medtronic Percept DBS as standard of care treatment for PD
- •Clinically optimized DBS parameters for one month prior to enrollment
- •Ability to ambulate with or without an assistive device for 5 continuous minutes
- •Willingness to withhold antiparkinsonian medication and DBS stimulation for outcomes assessments
排除标准
- •Neurocognitive impairment that compromises the ability to provide informed consent
- •Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
- •Recommendation for medical clearance using the American College of Sports Medicine (ACSM) Preparticipation Health Screen:
- •If the ACSM screen recommends medical clearance, the subject must obtain medical clearance by their health care provided prior to participation.
- •Those who choose not to obtain physician clearance will not be eligible for participation. Those who do not receive physician clearance for high intensity exercise will not be eligible.
- •A musculoskeletal issue (arthritis, osteoporosis, back problem) that would limit one's ability to engage in exercise
- •Current cardiac arrhythmia
结局指标
主要结局
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)
时间窗: Baseline to EOT and Baseline to EOT+4 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. Change in MDS-UPDRS III score from baseline to end-of-treatment (EOT) and baseline to EOT+4 weeks.
Relative Root Mean Square Error of a Grip Force Tracking Task
时间窗: Baseline to EOT and Baseline to EOT+4 weeks
Participants are required to modulate the precision grip force of their dominant hand to match a target trajectory on a computer screen. Relative root mean squared error quantifies deviation from the target force trajectory. Values are normalized for maximum target amplitude, with lower values indicating decreased error.
Local Field Potential Subthalamic Nucleus Beta at Rest
时间窗: Baseline to EOT and Baseline to EOT+4 weeks
Normalized beta band activity is reported as the change in resting-state STN beta band (13-30Hz) power. Higher beta band suggests increased pathological electrical synchrony.
次要结局
未报告次要终点