Comparing Different Montages of Transcranial Direct Current Stimulation Combined With Dual-task Training on EEG Microstates A Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Microstates EEG
研究概览
简要总结
This study investigates whether electroencephalographic (EEG) measures of functional connectivity of the target network are associated with the response to different sets of transcranial direct current stimulation combined with dual-task training in post-stroke patients.
详细描述
The present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dual-site anodic tDCS (M1 + DLPFC) and simulated tDCS on functional connectivity, as assessed by EEG, in patients after staged stroke. chronic. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial. Participants will be submitted to three sessions, each session consisting of a different condition, namely: anodic tDCS - participants who will receive real current over the primary motor area; Dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and simulated tDCS - participants who will receive simulated stimulation. Participants will receive 3 tDCS sessions, lasting 20 minutes, associated with a physical therapy protocol based on dual motor and cognitive tasks, on alternate days (3 times a week). On each intervention day, pre and post-intervention assessments will be carried out, the evaluated outcomes will be: functional connectivity (EEG), functional mobility (Timed Up and Go) and executive functions (Trail-making Test A and B, the Clock Drawing Test and Phonemic Verbal Fluency Test). Statistical performance will be performed using SPSS software (Version 20.0) and MATLAB 9.20 with a significance level of 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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-stroke participants for more than 6 months
- •Individuals over 18 years of age;
- •Both sexes;
- •Patients with mild to moderate degree of injury severity (NIHHS <17 points)
排除标准
- •Patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor);
- •Habitual use of drugs or alcohol;
- •Use of drugs that modulate the activity of the Central Nervous System;
- •Gestation;
- •Use of metallic / electronic implants and / or cardiac pacemakers;
- •Participants unable to communicate verbally;
研究组 & 干预措施
Anodal tDCS + dual-task training
The anodic electrode (5x5 cm) will be applied to the primary motor area (C3/C4) ipsilateral to the lesion and the reference electrode (6x9 cm) to the deltoid muscle region.
Simultaneously with the tDCS sessions, participants will be submitted a protocol based on motor and cognitive dual-task training. The dual-task training will have a total duration of 20 minutes in each session.
干预措施: Transcranial direct current stimulation (Device)
tDCS dualsite + dual-task training
Two active electrodes (5x5 cm) will be used, which will be positioned over the primary motor area (C3/C4) and over the dorsolateral prefrontal cortex (F3 or F4) in the ipsilateral hemisphere. For this stimulation modality, two active electrodes (anodic) and a reference electrode (6x9 cm) will be used on the deltoid muscle region.
Simultaneously with the tDCS sessions, participants will be submitted a protocol based on motor and cognitive dual-task training. The dual-task training will have a total duration of 20 minutes in each session.
干预措施: Transcranial direct current stimulation (Device)
tDCS sham + dual-task training
Two electrodes will be used, which will be positioned over the primary motor area (C3/C4) and a reference electrode (6x9 cm) will be used on the deltoid muscle region, however the device will be configured in sham mode.
Simultaneously with the tDCS sessions, participants will be submitted a protocol based on motor and cognitive dual-task training. The dual-task training will have a total duration of 20 minutes in each session.
干预措施: Transcranial direct current stimulation (Device)
结局指标
主要结局
Microstates EEG
时间窗: The evaluations will be carried out in pre-intervention
EEG data were processed according to the following steps and parameters: (1) downsampled to 256 Hz; (2) high-pass filter at 2 Hz and low-pass at 20 Hz; (3) visual inspection and artifact removal; (4) correction of eye movement using the independent component analysis; and (5) segmentation into two-second epochs with 10% overlap. The choice for the 2-20 Hz range frequency band. Data were submitted to processing: determination of global field power; clustering using k-means of topographic maps of global field power peaks; determination of the optimal number of topographic maps using a predetermined criterion of the four classic maps (A, B, C, and D); application of the topographic maps to the EEG signal using spatial correlation; and classification of EEG continuous data according to the topographic map with the most correlated sections. We calculated and extracted the global explained variance, coverage, occurrence, and duration from each topography.
Functional connectivity
时间窗: Immediately after the intervention
EEG data were processed according to the following steps and parameters: (1) downsampled to 256 Hz; (2) high-pass filter at 2 Hz and low-pass at 20 Hz; (3) visual inspection and artifact removal; (4) correction of eye movement using the independent component analysis; and (5) segmentation into two-second epochs with 10% overlap. The choice for the 2-20 Hz range frequency band. Data were submitted to processing: determination of global field power; clustering using k-means of topographic maps of global field power peaks; determination of the optimal number of topographic maps using a predetermined criterion of the four classic maps (A, B, C, and D); application of the topographic maps to the EEG signal using spatial correlation; and classification of EEG continuous data according to the topographic map with the most correlated sections. We calculated and extracted the global explained variance, coverage, occurrence, and duration from each topography.
次要结局
- Executive Functions III(Immediately after the intervention)
- Executive Functions II(Immediately after the intervention)
- Timed up and Go test(Immediately after the intervention)
- Executive Functions I(Immediately after the intervention)
- Timed up and Go test(The evaluations will be carried out in pre-intervention)
- Executive Functions I(The evaluations will be carried out in pre-intervention)
- Executive Functions II(The evaluations will be carried out in pre-intervention)
- Executive Functions III(The evaluations will be carried out in pre-intervention)
研究者
Suellen Marinho Andrade
Federal University of Paraíba
Federal University of Paraíba