跳至主要内容
临床试验/NCT02457832
NCT02457832已完成不适用

Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Connectivity Strength

研究概览

简要总结

The purpose of this research study is to learn more about brain activity when individuals with and without Parkinson disease (PD) move their lower limbs. The investigators also want to see if and how two different types of partnered dance affect brain activity in individuals with and without PD. Testing will take place at the Atlanta VA Medical Center and at Emory University. The investigators expect to enroll about 140 people for this study over a five-year period.

详细描述

Persons with Parkinson's disease (PD) have impaired mobility, which adversely affects their quality of life. The effectiveness of adapted tango dance, in which participants both lead (internally guide: IG) and follow (externally guide: EG) movement has been shown. To improve outcomes in those with PD, the underlying brain mechanisms for both motor impairments and improvement must be studied. IG and EG movements have distinct brain activity patterns. Individuals with PD have trouble with IG movement but this problem is helped by strategies used while "leading." During "following", participants with PD can use many external cues, which helps movement in PD, because EG tasks bypass the basal ganglia, the part of the brain affected by PD. In older persons with PD, the investigators aim to:

  • determine brain activation patterns during IG and EG foot movement.
  • look into effects of IG and EG training on brain activation along with mobility improvements.

The investigators will begin with a functional Magnetic Resonance Imaging test in a scanner. The investigators will look at brain area correlates of a clinically-used foot-tapping task, during IG and EG conditions in older persons with and without PD. Then, the investigators will assess the relative effectiveness of IG versus EG training during an adapted tango class, compared to a group that participates in health education, for improved mobility and foot tapping. Participants with PD will be assessed for disease severity. They will receive tests of outcome measures while "OFF" and "ON" PD-specific medications at the following time points:

  • 1 week before training
  • 1 week after training
  • 1 month after training Participants must attend 20 lessons of IG or EG adapted tango in 12 weeks, taught by an experienced instructor. In the functional MRI (fMRI) scanner, the investigators will assess participants for improved foot tapping after training. The investigators will also look at changes in activation in specific brain circuits along with training effects upon mobility.

The long-term goal is to improve motor training as much as possible for persons with PD by understanding foot movement brain circuitry in PD as well as brain changes in circuitry through which training is effective. This work proposes to illumine information about brain function that is very important to continued progress in rehabilitative care of persons with PD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40 - 70 years
  • Willingness to spend 1-h in a scanner
  • Able to walk with or without an assistive device 10 feet
  • Best corrected/aided acuity better than 20/70 in the better eye
  • Absence of dementia or vascular cognitive impairment
  • Absence of primary memory deficits

排除标准

  • Deep brain stimulator implants, Metallic implants, fragments, or pacemakers
  • Montreal Cognitive Assessment (MocA) score < 24
  • Pure-tone threshold sensitivity > 40 dB
  • Peripheral neuropathy
  • Untreated Major Depression
  • History of stroke, or traumatic brain injury

结局指标

主要结局

Connectivity Strength

时间窗: 12 weeks

Changes in average connectivity strength across striatal-thalamo-cortical (STC) and cerebello-thalamo-cortical (CTC) circuits, as measured by average cross correlation coefficient between the seed regions of the circuits.

Percent Signal Change

时间窗: 12 weeks

Percentage of baseline BOLD signal across activated brain regions. Activation values that remain significant after type-I error control in imaging software are averaged across brain regions, converted to Percent Signal Change, and presented as Mean (%) ± SD (%) across brain regions investigated.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Motor Training in PD | 临床试验