Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial
Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke
研究概览
地位
条件
详细说明
Participants will be divided into 03 groups: G1: anodic tDCS - participants who will receive real current over the primary motor area; G2: dualsite tDCS - participants who will receive real current over the primary motor area and over the dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will be entered into the study through the eligibility criteria and will be randomly allocated, with block exchange at a rate of 1:1:1.
In each phase of the study, participants will receive 10 tDCS sessions, for 20 minutes, on alternate days (3 times a week, excluding weekends). The TCT-Research neurostimulator will be used for stimulation. The electrodes will be positioned according to the 10-20 international electroencephalogram classification system. Electrodes wrapped in sponges, moistened with saline solution (0.9% NaCl) will be used. The applied current will be 2mA (5x5 cm active electrodes; 25 cm2; current density of 0.08 mA/cm2).
For group 1 (anodic tDCS) 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. In group 2 (dualsite tDCS) 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.
For group 3 (simulated tDCS) the positioning of the electrodes will be the same as for group 1, however the device will be configured in sham mode in which the current will cease 30 seconds after the start of stimulation, in this way the effects of active stimulation will be simulated and the participants will perceive the sensations typically felt, but without the induction of clinical effects (Nitsche & Paulus, 2000). At the end of each session, participants will be asked to report any unpleasant effects and asked about possible adverse effects. In addition, all participants will be blind to the type of stimulation they will receive.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Suellen Andrade
- 电话号码：+5583999805189
- 邮箱：suellenandrade@gmail.com
学习地点
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Paraíba
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João Pessoa、Paraíba、巴西、58051-900
- 招聘中
- Federal University of Paraíba,Department of Psychology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Single episode of unilateral, ischemic stroke in middle cerebral artery proven by means of magnetic resonance imaging or computed tomography.
- Classification of brain injury based on the criteria: Oxfordshire Community Stroke Project (OCSP) or Trial of Org 10172 in Acute Stroke Treatment (TOAST);
- Patients in the chronic stage (after six months after the injury)
- Individuals over 18 years of age;
- Both sexes;
- Absence of mental disorders, assessed using the Self Reporting Questionnaire (SRQ-20), with a cut-off point of 7/8 points.
- Absence of cognitive deficits, assessed using the Mini Mental State Examination (MMSE> 24).
- Patients with mild to moderate degree of injury severity (NIHHS <17 points).
Exclusion Criteria:
Patients with other associated pathologies that can influence motor activity (example: traumatic brain injury, brain tumor);
•- Participants unable to complete the initial assessment due to severe aphasia (Token Test <17);
- 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;
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Group 1 - anodal tDCS
Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20. For group 1 (anodic tDCS) 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 to a physical therapy protocol based on motor and cognitive dual-task training. Each task will have a duration of 3 minutes, followed by a rest period of 30s. |
tDCS dualsite 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.
其他名称：
tDCS sham 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.
其他名称：
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有源比较器：Group 2 - tDCS dualsite
Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20. In group 2 (dualsite tDCS) 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 to a physical therapy protocol based on motor and cognitive dual-task training. Each task will have a duration of 3 minutes, followed by a rest period of 30s. |
tDCS sham 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.
其他名称：
anodal tDCS 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.
其他名称：
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安慰剂比较：Group 3 - tDCS sham
Participants will receive 10 tDCS sessions, for 20 minutes, on days alternate (3 times a week). The neurostimulator TCT-Research will be used for stimulation. The electrodes will be positioned according to the international classification system of the electroencephalogram 10/20. For group 3 (simulated tDCS) the positioning of the electrodes will be the same as for group 1, however the device will be configured in sham mode in which the current will cease 30 seconds after the start of stimulation. Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training. Each task will have a duration of 3 minutes, followed by a rest period of 30s. |
tDCS dualsite 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.
其他名称：
anodal tDCS 837 / 5.000 Resultados de tradução Simultaneously with the tDCS sessions, participants will be submitted to a physical therapy protocol based on motor and cognitive dual-task training, which will include: (1) walking repeating phrases spoken by the researcher; (2) walking counting numbers in ascending order; (3) walk while counting the numbers in descending order; (4) walking during the execution of a string of words; (5) Walking while listening to a list of fruits and saying "YES" when hearing the word "strawberry" and (6) walking reciting a phrase backwards. Each task will have a duration of 3 minutes, followed by a rest period of 30s. The tasks will be performed performing forward, side and back march. Subjects will be instructed to focus on both tasks. The training will have a total duration of 20 minutes in each session.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Fugl-Meyer assessment (FMA) pre-intervention (T0)
大体时间：The evaluations will be carried out in pre-intervention (T0)
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Fugl-Meyer assessment (FMA) for lower limbs pre-intervention (T0)
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The evaluations will be carried out in pre-intervention (T0)
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Fugl-Meyer assessment (FMA) after the stimulation protocol (T1)
大体时间：The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Fugl-Meyer assessment (FMA) for lower limbs after the stimulation protocol (T1)
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional connectivity (EEG) pre-intervention (T0)
大体时间：The evaluations will be carried out in pre-intervention (T0)
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The functional connectivity of the target network will be assessed, through the acquisition of the EEG
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The evaluations will be carried out in pre-intervention (T0)
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Functional connectivity (EEG) after the stimulation protocol (T1)
大体时间：The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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The functional connectivity of the target network will be assessed, through the acquisition of the EEG
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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EQ-5D (T0)
大体时间：The evaluations will be carried out in pre-intervention (T0).
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Quality of life.
Presenting a final score from 0 to 100, where 0 corresponds to the worst general state of health and 100 the best state of health.
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The evaluations will be carried out in pre-intervention (T0).
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EQ-5D (T1)
大体时间：The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Quality of life.Presenting a final score from 0 to 100, where 0 corresponds to the worst general state of health and 100 the best state of health.
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Modified Rankin Scale pre-intervention (T0)
大体时间：The evaluations will be carried out in pre-intervention (T0).
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Functional disability. The score on the Rankin scale ranges from 0 to 6, in order to assess the patient's neurological condition, in which the higher the value, the worse the condition. 0 - No symptoms
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The evaluations will be carried out in pre-intervention (T0).
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Modified Rankin Scale after the stimulation protocol (T1)
大体时间：The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Functional disability. The score on the Rankin scale ranges from 0 to 6, in order to assess the patient's neurological condition, in which the higher the value, the worse the condition. 0 - No symptoms
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Balance
大体时间：The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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Biodex Balance System (BBS)
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The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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Balance
大体时间：The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Biodex Balance System (BBS)
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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MoCA
大体时间：The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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Cognitive function
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The T0 assessment will be performed up to one week after the stimulation protocol is completed.
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MoCA
大体时间：The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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Cognitive function
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The T1 assessment will be performed up to one week after the stimulation protocol is completed.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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