THE IMMEDIATE EFFECT OF ELECTRICAL STIMULATION TRANSCRANIAL DIRECT CURRENT (tDCS) ON CARDIORESPIRATORY PARAMETERS IN HEMIPARETICS ADULTS PATIENTS DUE TO STROKE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cardiac Frequency Variability (HRV) as measured by spectral analysis by Polar RS800 cx.
研究概览
简要总结
Previous studies found important function of brain in exercises regulation on healthy and athlete patients and this studies showed not invasive stimulation on temporal cortex brain, induces electrics field to insula cortex, in addition modulate autonomic nervous system cognition efforts during submaximal (maximal hight frequency) and maximal exercises. Measure immediate effects of transcranial stimulation in bloodstream (tDCS) anodic on right and left temporal cortex in the cardiorespiratory parameters (functional capacity, perception of efforts and modulation of autonomic nervous system) in patients with hemiparesis due stroke. Methods and Material: It Is a clinical trial, controlled and Double blind, using 30 adult patients with stroke sequel, like roam. Evaluation will be hemodynamic measure data such as: Heart Rate, Respiratory Rate, Blood Pressure, Lung Capacity Vital and assessment of the Autonomic Nervous System, before and after anodic electro stimulation from bloodstream on right and left temporal cortex region (T3 area) and cathodic position in contralateral supraorbital region to anode (Fp2). On temporal cortex will be applied of 2mA during stimulation of 20 minutes. Sham stimulation all electrodes Will be used. The stimulator turns on for 30 seconds. Results: The primary results will analyze cardiac frequency before and after tDCS and second step will assess the travelled distance on walking test for 6 minutes with and without tDCS and compare these respiratory reviews results with stroke gravity.
详细描述
This is a clinical protocol, randomized, crossover, double-blind (patient and data analyst) will be held. The study protocol is registered in clinicalTrials.gov - NCT02398344.
Methods
Individuals with AVE will be recruited from the physical therapy clinics of the Universidade Nove de Julho - Sao Paulo, Brazil. The participants will be recruited and selected based on the following eligibility criteria:
Sample size Sample of 20 the participants (05 participants in each level of motor impairment - mild, moderate, marked and severe) will taken. This value will assumed, based on studies of Okano et al.²⁰ evaluating HRV after tDCS in 10 athletes and Vandermeeren et al.²⁶ that evaluated the effect of tDCS over the cardiorespiratory system in 30 healthy individuals.
As the primary outcome will considered the heart rate variability, validated for the population of adults with hemiparesis after a stroke and a variable considered secondary outcome, by correlating the functional capacity with the severity of the stroke, the 6-minute walk test, considering the cardiorespiratory fitness and the patient's mobility before and after the application of tDCS and correlate whether there are differences on the immediate effect of tDCS applied in both cerebral hemispheres (right and left).
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 individuals wich hemiparesis stemming from a stroke;
- •Rating of Functional Mobility Scale levels (FMS- functional mobility scale)
- •Walking at least 50 meters (GRAHAN et al. 2004); Science signature in consent term exempt and enlightened (TCLE) .
排除标准
- •Positive Cutoff to cognitive wastage screening (mental mini) - Visual commitment may intervene in tests achievement;
- •Cardiac vast problems and use of pacemaker;
- •Contraindication of tDCS application (history of recurrent seizures, recurrent epilepsy and brain tumor in stimulation site);
结局指标
主要结局
Cardiac Frequency Variability (HRV) as measured by spectral analysis by Polar RS800 cx.
时间窗: 1 years
Individuals with right lesion, after anodal tDCS wolf T3 (healthy): BF (p=0,32), AF(p=0,88), LF/HF (p=0,18); tDCS in T4 (injured): BF (p=0,90), AF (p=0,19) and LF/HF (p=0,29). Individuals with left foot injury, tDCS in wolf T3 (injured) BF (p=0,15), AF (p=0,12) and LF/HF (p=0,81) and tDCS wolf T4 (healthy): BF (p=0,89), AF (p=0,18) and LF/HF (p=0,34).
次要结局
未报告次要终点
研究者
Catarina Novaes Sousa Bertani
Catarina Novaes Sousa Bertani
University of Nove de Julho