Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety of the intervention as assessed by frequency of adverse events
研究概览
简要总结
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
详细描述
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
- •Unilateral paresis of upper limb
- •National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
- •Ability to provide written informed consent (patient ou legal representative).
排除标准
- •Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
- •Neurologic diseases except migraine.
- •Modified Rankin Scale > 2 prior to stroke.
- •Advanced systemic disease such as cancer or advanced chronic renal disease.
- •Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
- •Contraindication for physical therapy.
- •Pregnancy.
- •Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
- •Comprehension aphasia
- •Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
研究组 & 干预措施
Active tDCS+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)
干预措施: Active tDCS (Device)
Active tDCS+ Physical Therapy
Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks)
干预措施: Physical Therapy (Other)
Sham tDCS+Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks)
干预措施: Physical Therapy (Other)
Sham tDCS+Physical Therapy
Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes.
Number of treatment sessions: 6 (3 times a week, for 2 weeks)
干预措施: Sham tDCS (Device)
结局指标
主要结局
Safety of the intervention as assessed by frequency of adverse events
时间窗: 2 weeks
frequency of adverse events in the active and sham arms
次要结局
- Improvement post treatment as measured by the Barthel index(2 week and 14 weeks)
- Safety of the intervention as assessed by frequency of adverse events(14 weeks)
- Improvement post treatment as measured by the Motor Activity Log(2 weeks and 14 weeks)
- Improvement post treatment as measured by the Modified Rankin Scale(2 weeks and 14 weeks)
- Improvement post treatment as measured by the NIH Stroke Scale(2 weeks and 14 weeks)
- Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke(2 weeks and 14 weeks)
- Improvement post treatment as measured by Pittsburgh Sleep Quality Index(2 week and 14 weeks)
- Improvement post treatment as measured by the Stroke Impact Scale(2 weeks and 14 weeks)
- Improvement post treatment as measured by the Modified Ashworth Scale(2 weeks and 14 weeks)
- Montreal Cognitive Assessment Test(2 weeks and 14 weeks)
- Structural Connectivity as measured by diffusion tensor imaging analysis(2 weeks)
- Functional Connectivity as measured by resting-state functional magnetic imaging analysis(2 weeks)