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临床试验/NCT02956096
NCT02956096Unknown不适用

Evaluation of Autonomic Modulation in the Hemiparetic Patients After Transcranial Direct Current Stimulation (tDCS) and Treadmill Training: Clinical Trial, Controlled, a Randomized, Double-blind

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Heart rate variability

研究概览

简要总结

Introduction: Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.

Objective: To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.

详细描述

Introduction

Patients post-stroke may have autonomic dysfunction, with increased blood pressure, heart rate (HR) and increased risk of sudden death. Studies have shown that transcranial direct-current stimulation (tDCS) can modulate the autonomic nervous system in healthy subjects, but little is known about these effects in stroke.

Objective

To evaluate the effect of tDCS after treadmill training in the autonomic nervous system modulation in patients post-stroke.

Methods: Clinical study, crossover, controlled, randomized, double-blind individuals with hemiparesis after stroke adults. Patients will undergo a spirometric evaluation (Harbor protocol modified with constant speed, determined by the individual and the incline of the treadmill with incremented 2.5% every 2 minutes). The next day will begin with one of the two randomized protocols, one week interval between them: 1 (tDCS active and treadmill), 2 (tDCS placebo and treadmill). Each protocol will last 40 minutes (20min of tDCS over 20min mat). They will be evaluated heart rate variability (HRV) and blood pressure variability (VPA) before a minute for the protocols and in the recovery phase, for 15 minutes. 2mA current intensity, the anode electrode over the left temporal cortex and cathode on the contralateral deltoid muscle. Considering the neurophysiological effects of noninvasive techniques neuromodulators plasticity before the modulation of the autonomic nervous system, it is concluded that this study shows potential for the discovery of a new therapeutic tool in the rehabilitation of patients with stroke and hypertension. The hypothesis is that increasing the excitability of the left insular cortex, a modulation of the autonomic nervous system in controlling the variability in systolic blood pressure and heart rate is possible in conjunction with aerobic training, can provide greater hemodynamic effectiveness and decrease the time training. It is also understood that the study may have impact on the reduction of public costs spent on the rehabilitation of patients with stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • present hemiparesis due to stroke for more than 6 months;
  • Commitment mild or moderate motor in the lower member (20 to 31 points), according to the scores of Fugl-Meyer test
  • comfortable walking speed on the ground between 0.3 and 1.15 m / s;
  • Rating between levels 04-06 on Functional Mobility Scale (FMS) - Functional Mobility Scale and ambulate at least 50 meters
  • Presentation of the AVE imaging
  • Science Signature regarding the free and informed consent (WIC).

排除标准

  • present cognitive impairment (mini mental) with scores below 24 points;
  • visual impairment that may interfere with the performance of the tests;
  • severe heart failure (congestive heart failure, angina, peripheral vascular disease), pacemaker use, β-blockers and propranolol;
  • contraindications to the use of tDCS (brain implants of metal clips near the region to be stimulated, history of recurrent seizures, recurrent epilepsy and brain tumors, brain pacemaker and / or plates or metal devices in place of stimulation tDCS)
  • irregular menstrual cycle or be in the menstrual period during the evaluation;
  • No medical certificate for treadmill exercise test

结局指标

主要结局

Heart rate variability

时间窗: 1 years

Cardiac Frequency Variability (HRV) as measured by spectral analysis by Finomiter (FMS, Finapres Measurement Systems, Arnhem, Netherlands), in ms²

次要结局

  • Blood pressure variability(1 years)

研究者

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

Glauber Heinz

Physiotherapist

University of Nove de Julho

研究点 (2)

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