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临床试验/NCT02954211
NCT02954211撤回不适用

rTMS and Physical Therapy as a Clinical Service for People With Stroke

University of Minnesota0 个研究点开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Box and Block Test

研究概览

简要总结

The purpose of this study is to determine the characteristics that distinguish responders from nonresponders in people with stroke receiving rTMS combined with physical therapy to improve hand function. Investigators hypothesize that those who improve the most will be characterized by larger evoked brain signals in the stroke hemisphere and lower scores on the Beck Depression Inventory indicating less depression. Medications, sex, age, type of stroke, location of stroke, duration of stroke and baseline hand function will also be compared.

详细描述

Stroke is the leading cause of long-term disability in the United States. The disability stems not only from neurons killed by the stroke but also from neurons that become dormant from non-use and other reasons. The killed neurons cannot be recovered but the excitability of the dormant neurons can be improved. Increasing this excitability makes for easier voluntary recruitment of these neurons in patients, which translates to improved voluntary function and quality of life. Investigators have used repetitive transcranial magnetic stimulation (rTMS) for 10 years at the University of Minnesota in strictly a research mode. Investigators have found that some people benefit from the rTMS and some do not. Investigators also have observed that some people in prior studies have asked to receive rTMS after research participation had concluded and people were willing to pay for the service privately. However, until recently, investigators were not able to offer such service. Investigators have succeeded in getting approval from the University of Minnesota that allows rTMS combined with physical therapy to be given to outpatients with stroke who have physician referral. Patients will receive an initial block of five rTMS/physical therapy (rTMS/PT) treatments to the nonstroke hemisphere and, if early signs of benefit are shown, the patients will receive a second block of 5 additional treatments. If patients do not show improvement, an alternative approach involving rTMS to the stroke hemisphere will be offered. Patients will be informed in advance of the cost, that most insurance carriers will not cover the cost, and that patients would have to pay privately for treatments. The research component of this project involves collecting hand function data along with stroke characteristics to conduct a responder vs. nonresponder analysis. In this way, investigators would be providing clinical service to patients who desire this treatment while learning further the characteristics of those who benefit and those who do not, which would guide future treatment decisions.

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

  • Stroke (ischemic or hemorrhagic, cortical or subcortical) of at least 5 days duration, at least 10 degrees of voluntary finger motion in the paretic hand but slower or not as far compared to the nonparetic hand, over 18 years of age

排除标准

  • Seizure within the past two years, receptive aphasia, epileptogenic medication, major psychiatric disorder, metal in the head (dental permitted), pacemaker or other indwelling devices, other interfering comorbidities (fracture, etc), pregnant

研究组 & 干预措施

rTMS/PT

Experimental

There will be only one group. All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.

干预措施: repetitive transcranial magnetic stimulation (rTMS) (Device)

rTMS/PT

Experimental

There will be only one group. All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.

干预措施: Physical therapy (Behavioral)

结局指标

主要结局

Box and Block Test

时间窗: Measured at baseline and after one week and two weeks of treatments

Determines the change from baseline to posttest in the number of 1-inch cubes that the person can grasp between finger and thumb and move from one box and dropped into an adjacent box in one minute (x3 trials)

次要结局

  • MEP Amplitude(Measured at baseline and after one week and two weeks of treatments)

研究者

申办方类型
Other
责任方
Sponsor

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