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临床试验/NCT02263092
NCT02263092Unknown1 期

Effects of Transcranial Direct Current Stimulation Associated With Physical Exercise: a Metaplasticity Study

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
12
试验地点
1
主要终点
Change on cortical excitability - motor evoked potential (MEP)

研究概览

简要总结

This study aims to understand metaplasticity through the association of transcranial direct current stimulation (tDCS) and physical exercise. For this purpose, the study will be separate in 2 phases: in the first phase the aim is verify the effects of physical exercise on cortical excitability. After this 1st phase two intensities of physical exercise will be chosen for the second phase. In the 2nd phase, subjects will undergo to anodal, cathodal and sham tDCS plus physical exercise.

详细描述

Before the two phases of the study, the subjects will be evaluate in the following aspects: anxiety by the beck anxiety inventory; depression by the beck depression inventory; level of physical exercise by the international physical activity questionnaire; stress by the stress perceived scale 10.

In the first phase, the subjects will be undergo to 4 conditions: (i) 15 minutes of physical exercise with moderate intensity; (ii) 10 minutes of physical exercise with high intensity; (iii) 30 minutes of physical exercise with mild intensity; (iv) 15 or 30 minutes of rest. Before each condition, cortical excitability will be measure through the Transcranial magnetic stimulation by motor evoked potential (MEP); the blood glucose level will be evaluate by glucometer. The MEP also will be done immediately after the physical exercise and in every 5 min for 30 after the end of exercise/rest. The blood glucose level will be done immediately after the exercise..

In the second phase, the subjects will be undergo to 6 conditions: (i) anodal tDCS + physical exercise 1; (ii) anodal tDCS + physical exercise 2; (iii) cathodal tDCS + physical exercise 1; (iv) cathodal tDCS + physical exercise 2; (v) sham tDCS + physical exercise 1; (vi) sham tDCS + physical exercise 2. The intensity and time of physical exercise depends of the results of the previous phase and will be determine after the end of phase 1. In this phase, the blood glucose level will be evaluate before and immediately the physical exercise. The cortical excitability will be evaluate through the Transcranial magnetic stimulation by the following measures: motor evoked potential - before the tDCS,after tDCS, immediately , 10, 20, 30, 60, 90 minutes after the exercise; resting motor threshold - before tdcs, immediately and 90 minutes after the exercise; recruitment curve - before tdcs, immediately and 90 minutes after the exercise.

tDCS condition During tDCS application, patients will be seated in a comfortable chair with head and arms rests. Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 35 and 36cm²).

tDCS will be applied to Cz and Oz according to International 10-20 EEG system. In the anodal tDCS, the anode will be placed in Cz and cathode in Oz. In the cathodal tDCS the inverse position will be done. Parameters of current intensity and duration (dose) used were previously established in poststroke patients: 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Self reported healthy
  • •Right handed

排除标准

  • •Prior neurological diseases
  • •Multiple brain lesions
  • •Metal implant in the skull and face
  • •Pacemaker
  • •History of seizures
  • •Pregnancy
  • •Hemodynamic instability
  • •Use of medications which change the cortical excitability, such as antidepressants, anxiolytics.
  • •Energy expenditure > 3000 METS

研究组 & 干预措施

15 minutes of physical exercise

Experimental

the subjects will do physical exercise on a treadmill with 64 to 74% of maxHR

干预措施: Physical exercise (Behavioral)

10 minutes of physical exercise

Experimental
  • the subjects will do physical exercise on a treadmill with 77 to 95% of maxHR.

干预措施: Physical exercise (Behavioral)

30 minutes of physical exercise

Experimental
  • the subjects will do physical exercise on a treadmill with 57 to 63% of maxHR.

干预措施: Physical exercise (Behavioral)

Rest/control

Experimental

the subjects will be on 15 or 30 minutes seat without move the legs.

干预措施: Rest (Behavioral)

Anodal tDCS + physical exercise 1

Experimental

the subjects will be undergo to anodal tDCS + physical exercise 1

干预措施: Physical exercise (Behavioral)

Anodal tDCS + physical exercise 1

Experimental

the subjects will be undergo to anodal tDCS + physical exercise 1

干预措施: tDCS (Device)

Anodal tDCS + physical exercise 2

Experimental

the subjects will be undergo to anodal tDCS + physical exercise 2

干预措施: Physical exercise (Behavioral)

Anodal tDCS + physical exercise 2

Experimental

the subjects will be undergo to anodal tDCS + physical exercise 2

干预措施: tDCS (Device)

Cathodal tDCS + physical exercise 1

Experimental

the subjects will be undergo to cathodal tDCS + physical exercise 1

干预措施: Physical exercise (Behavioral)

Cathodal tDCS + physical exercise 1

Experimental

the subjects will be undergo to cathodal tDCS + physical exercise 1

干预措施: tDCS (Device)

Cathodal tDCS + physical exercise 2

Experimental
  • the subjects will be undergo to cathodal tDCS + physical exercise 2

干预措施: Physical exercise (Behavioral)

Cathodal tDCS + physical exercise 2

Experimental
  • the subjects will be undergo to cathodal tDCS + physical exercise 2

干预措施: tDCS (Device)

Sham tDCS + physical exercise 1

Experimental

the subjects will be undergo to sham tDCS + physical exercise 1

干预措施: Physical exercise (Behavioral)

Sham tDCS + physical exercise 1

Experimental

the subjects will be undergo to sham tDCS + physical exercise 1

干预措施: tDCS (Device)

Sham tDCS + physical exercise 2

Experimental

the subjects will be undergo to sham tDCS + physical exercise 2

干预措施: Physical exercise (Behavioral)

Sham tDCS + physical exercise 2

Experimental

the subjects will be undergo to sham tDCS + physical exercise 2

干预措施: tDCS (Device)

结局指标

主要结局

Change on cortical excitability - motor evoked potential (MEP)

时间窗: Phase 1 - in each session (every day), baseline and every 5 minutes for 30 minutes after exercise/rest. Phase 2 - in each session (every day), baseline, after, 10, 20, 30, 60 and 90 after tDCS + exercise

次要结局

  • Change on cortical excitability - resting motor threshold (RMT)(Phase 2 - in each session (every day), baseline, after and 90 after tDCS + exercise)
  • Change on cortical excitability - Recruitment curve (RC)(Phase 2 - in each session (every day), baseline, after and 90 after tDCS + exercise)

研究者

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

Kátia Monte-Silva

PHD

Universidade Federal de Pernambuco

研究点 (1)

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