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临床试验/NCT03442868
NCT03442868已完成不适用

Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年10月19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
15
试验地点
2
主要终点
Change in Gait Speed

研究概览

简要总结

The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.

详细描述

This study will enroll 12 individuals with a stroke at least 6 months ago. Participants will be tested across 3 sessions and each session will be approximately 1 week apart from each other. During testing, participants will be asked to walk under two conditions: single- and dual-task conditions. Under the single-task condition, participants walk on a instrumented mat such that their gait performance will be captured. Under the dual-task condition, participants walk on the mat while performing a counting backward task. The walking assessment is followed by a 12 minute non-invasive brain stimulation using high frequency rTMS. Another walking assessment will be conducted right after the brain stimulation session. High frequency rTMS will be applied to different neural loci, namely primary motor cortex (M1), supplementary motor area (SMA), and dorsolateral prefrontal cortex (DLPFC). The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age above 18 years
  • Diagnosis of Left hemispheric stroke at least 6 months ago
  • First time stroke OR complete gait recovery from prior stroke
  • Able to walk independently for at least 10 meters with or without walking aids
  • Have at least minimal movements (> 5 degree of motion) at the affected ankle
  • Score > 26 on Mini Mental State Exam (MMSE)
  • Ability to participate in the informed consent process

排除标准

  • Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis
  • Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis)
  • Unstable clinical conditions
  • Non-ambulatory prior to onset of stroke
  • History of significant head trauma
  • Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip
  • Metal implantation in the oral cavity, head/neck area and lower extremity
  • History of seizures or unexplained loss of consciousness
  • Immediate family member with epilepsy
  • Use of seizure threshold lowering medicine
  • Current abuse of alcohol or drugs
  • Anticipated inability to complete the study
  • History of psychiatric illness requiring medication control

结局指标

主要结局

Change in Gait Speed

时间窗: before and 10 minutes after the non-invasive brain stimulation

gait speed in m/s will be captured using GaitRite gait assessment walkway

次要结局

  • Change in Counting Task Performance(before and 10 minutes after the non-invasive brain stimulation)
  • Change in Step Lengths(before and 10 minutes after the non-invasive brain stimulation)
  • Change in Single Support Times(before and 10 minutes after the non-invasive brain stimulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui Ting Goh

Assistant Professor

Texas Woman's University

研究点 (2)

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