Expectation and Response to Levodopa & Acupuncture in Parkinson's Disease
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
- Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)
研究概览
简要总结
To investigate how levodopa and acupuncture affect fatigue and muscle function in people who suffer from Parkinson's disease. Subjects may choose to participate in levodopa or acupuncture part, or both. Study procedures include an exercise protocol, transcranial magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle twitch), a blood draw, and personality surveys.
详细描述
Subjects will answer surveys, have their blood drawn, undergo TMS and perform an exercise. The TMS/exercise task will measure fatigue and muscle response. The surveys will describe personality and measure fatigue. The CTRC will do genotype studies on the blood to look for genetic differences. Each subject is eligible to receive both study treatment types (levodopa and acupuncture). Depending upon the study treatment type they choose, each subject will be randomly assigned to one of six possible subject groups:
Ia. Full expectancy; levodopa: Subjects will be told that they are taking levodopa.
Ib. Half expectancy; levodopa: Subjects will be told that they have 50% chance of receiving levodopa or placebo.
Ic. No expectancy; levodopa: Subjects will be told that they are receiving placebo levodopa.
IIa. Full expectancy; acupuncture: Subjects will be told that they are receiving real acupuncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's disease
- •Able to withdraw Parkinson's disease medication for 12 hours prior to a study visit
- •Must be currently using levodopa to qualify for the levodopa part of the study
排除标准
- •History of seizures
- •Presence of any metal in the body, including DBS stimulators, pacemakers, metal plates or pins
- •Severe cognitive deficits or psychosis
- •Evidence of any clinically unstable disease, such as cancer, HIV/AIDS; unstable heart condition or other conditions that might require hospitalization
- •Evidence of another neurological disease, such as multiple sclerosis, amyotrophic lateral sclerosis, or Huntington's disease
结局指标
主要结局
Fatigue rate and muscle response evoked by transcranial muscle stimulation (TMS)
时间窗: Before and immediately after the intervention
次要结局
未报告次要终点
研究者
Barry S. Oken
MD
Oregon Health and Science University