Association Between Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation for Chronic Stroke Patients Rehabilitation: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Motor Function by means of the Wolf Motor Function Test
研究概览
简要总结
Cerebrovascular accident (CVA) is a cerebrovascular disease with high incidence and morbidity in the Brazilian population, and is considered a major cause of disability in adults. Brain damage caused by stroke generates a maladaptive pattern of neural activity and modulation between the cerebral hemispheres, unbalancing in the inter-hemispheric inhibition. This condition affects patient's functional recovery.
The aim of this study is to verify the effectiveness of repetitive transcranial magnetic stimulation Association (rTMS) in the cortex motor contralesional, Transcranial Direct Current Stimulation (tDCS) in the motor cortex ipsilesional and the association between these two types of brain stimulations on the upper limb recovery 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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subcortical stroke diagnosis, which has resulted in hemiparesis for at least 6 months and not more than 5 years (chronic condition);
- •Ability to reach 60 degrees in the shoulder flexion
- •Ability to completely extend the fingers in the affected upper limb;
- •Minimal cognitive ability to understand commands;
- •No current use of antiepileptic drugs for seizures.
排除标准
- •Painful shoulder, adhesive capsulitis or glenohumeral subluxation;
- •Contraindication (presence of metallic implants) or risks for the Transcranial magnetic stimulation, as evaluated by means of a standard questionnaire;
研究组 & 干预措施
tDCS
Patients who will be treated with Transcranial direct-current stimulation (tDCS) in the ipsilesional motor cortex.
干预措施: tDCS (Device)
rTMS
Patients who will be treated with Magnetic brain stimulation (rTMS) in the contralesional motor cortex.
干预措施: TMS (Device)
tDCS + rTMS
Patients who will be treated with the association between Transcranial direct-current stimulation (tDCS) and magnetic brain stimulation (rTMS), in the ipsilesional and contralesional motor cortex, respectively.
干预措施: tDCS + TMS (Device)
结局指标
主要结局
Motor Function by means of the Wolf Motor Function Test
时间窗: change from pre to post (at least 10 days)
次要结局
- Manual Dexterity by means of the Box and Block Test(change from pre to post (at least 10 days))
- Quality of Life by means of the Stroke Impact Scale(change from pre to post (at least 10 days))
- Grip strength via hand dynamometer(change from pre to post (at least 10 days))
研究者
Aline de Souza Pagnussat
Doctor
Federal University of Health Science of Porto Alegre