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临床试验/NCT05492435
NCT05492435招募中不适用

Changes in EEG Microestates After Combined Treatment od Tdcs and Dual-task Training in Stroke Patients: a Cross-roads, Sham-controlled,Double-blind Clinical Trial

Federal University of Paraíba1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
35
试验地点
1
主要终点
Changes in EEG microstates in each stimulation condition

研究概览

简要总结

Stroke has been considered one of the main causes of long-term disability in the adult population. Technological advances in the neurological area have been observed in the last decades, which accentuates the interest in promoting non-invasive stimulation techniques, capable of modulating brain polarity, where among these techniques is the transcranial direct current stimulation - tDCS. Previous studies analyzed by systematic reviews suggest that the effects of tDCS may vary between individuals, where some stroke patients may not receive any additional benefit from the therapy. Thus, it is necessary to use a biomarker that can choose those that will possibly benefit from the electric current. Therefore, the aim of this study is to identify the dynamics of EEG microstates after tDCS and dual-task training in subjects after chronic stroke, as well as to assess how microstate parameters in stroke patients are altered by tDCS and dual-task training. at three different moments (Stimulation in M1 + dual-task training; Stimulation in M1 and DLPF + dual-task training; Sham stimulation) and to observe whether the microstates encode information that reflects the motor and/or cognitive capacity of these patients.

详细描述

Cerebrovascular Accident (CVA) has been considered one of the main causes of long-term disability in the adult population. Stroke usually causes deficits such as asymmetrical muscle weakness between limbs, impaired proprioceptive ability, sensory loss, vision problems, and spasticity. In post-stroke patients, it is believed that the interhemispheric balance may be altered as a result of brain injury, the theory of interhemispheric competition is widely used as a theoretical basis for the application of non-invasive neuromodulatory techniques. Technological advances in the neurological field have been seen in recent decades, which accentuates the interest in promoting non-invasive stimulation techniques, capable of modulating brain polarity, where among these techniques is transcranial direct current stimulation - tDCS. Previous studies analyzed by systematic reviews suggest that the effects of tDCS may vary between subjects, where some stroke patients may not receive any additional benefit from the therapy. Thus, it is necessary to use a biomarker that can choose those who will possibly benefit from the electric current. Therefore, the aim of this study is to identify the dynamics of EEG microstates after tDCS and dual-task training in subjects after chronic stroke, as well as to assess how microstate parameters in stroke patients are altered by tDCS and dual-task training at three different times (Stimulation in M1 + dual-task training; Stimulation in M1 and DLPF + dual-task training; Sham stimulation) and observe whether the microstates encode information that reflects the motor and/or cognitive capacity of these patients. For this, a clinical trial, sham-controlled, double-blind and randomized, of crossover type, involving patients with stroke in chronic stage will be carried out. Participants will be submitted to three sessions, each session consisting of a different condition, namely: first condition (anodic tDCS) participants will receive real current over the primary motor area (M1); second condition (dualsite tDCS) participants will receive real current over M1 and dorsolateral prefrontal area (DLPFC) and third condition (sham tDCS) participants will receive simulated stimulation. A 3-minute resting EEG will be collected from each participant, and they will be instructed not to actively engage in any cognitive or mental activity. In all stimulation sessions, evaluations will be carried out, the evaluated outcomes will be: change in EEG microstates, cognitive function and motor function. Statistical analyzes will be performed using SPSS software (Statistical Package for Social Sciences - SPSS Inc, Chicago IL, USA for Windows, Version 20.0) and MATLAB (9.2.0 (MathWorks, Inc., Natick, MA) with a defined level of significance at p<0.05.

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, Care Provider)

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

  • Individuals diagnosed with stroke for more than 6 months;
  • Proven by means of magnetic resonance imaging or computed tomography;
  • Individuals aged 18 and over;
  • Both sexes;
  • Patients with mild to moderate degree of injury severity (NIHHS < 17 points)

排除标准

  • Individuals who are unable to communicate verbally;
  • Use of drugs that modulate the activity of the Central Nervous System;
  • Carriers of implanted metallic or electronic devices; cardiac pacemaker;
  • Habitual use of drugs or alcohol;
  • Report of history of epilepsy; gestation; people with traumatic brain injury or tumors.

结局指标

主要结局

Changes in EEG microstates in each stimulation condition

时间窗: immediately after the sessions

Microstate analysis was performed using the EEGLAB microstate plugin developed by Thomas Koenig (Koenig, 2021). First, at the individual level, we compute global field power (GFP) across all channels and microstate segmentation using the modified k-means clustering algorithm method to isolate map topographies. Polarity was ignored during microstate analysis. After obtaining the microstate segmentation of each participant, we calculated an average of the microstate segmentation of each group as models. The successive original individual EEG series were then divided into four classic microstate maps (they are labeled as four classes A, B, C and D, which are left-right direction (type A), left-right direction (type B), anteroposterior direction (type C) and frontocentral maximum (type D)).

次要结局

  • Cognitive function - verbal fluency test (VF).(immediately after the sessions)
  • Cognitive function - trail test (TMT) A and B(immediately after the sessions)
  • motor function(immediately after the sessions)
  • Cognitive function - clock drawing test(immediately after the sessions)

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suellen Andrade

Dra

Federal University of Paraíba

研究点 (1)

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