A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Functional Independence measured by Barthel Index
研究概览
简要总结
The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke
详细描述
Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.
In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.
However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.
With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischaemic acute stroke
- •Informed consent
排除标准
- •25 ≤ National Institute of Health Stroke Scale ≤ 32
- •Rankim ≥ 5
- •Mini Mental State Examination ≤ 24
- •tDCS criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system CIMT criteria: inability to actively execute the movements of wrist flexion, metacarpophalangeal and interphalangeal active extension of 10º and wrist extension of 20º
结局指标
主要结局
Functional Independence measured by Barthel Index
时间窗: Change for functional independence at 4 months
次要结局
- Muscle strength(Baseline, Week 2 and Week 4)
- Balance(Baseline, Week 2 and Week 4)
- Upper limb function(Baseline, Week 2 and Week 4)
- Spasticity(Baseline, Week 2 and Week 4)
- Quality of life(Baseline, Week 2 and Week 4)
- Lower limb function(Baseline, Week 2 and Week 4)
- Cognitive dysfunction (Montreal Cognitive Assessment)(Baseline (week 1) and Endpoint (week 4))
- Attention and Working Memory (Digit span subtest)(Baseline (week 1) and Endpoint (week 4))
- Executive functions (Victoria version of the Stroop Color and Word Test)(Baseline (week 1) and Endpoint (week 4))
- Posture(Baseline, Week 2 and Week 4)
- Fear of falling during daily life activities(Baseline, Week 2 and Week 4)
研究者
Suellen Marinho Andrade
MSc
Federal University of Paraíba