Transcranial Direct Current Stimulation in Rehabilitation of Chronic Stroke Patients: Multicenter Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Change in Fugl-Meyer assessment of paretic upper limb motor function
研究概览
简要总结
In this study, the investigators wondered whether bihemispheric transcranial direct current stimulation (tDCS) would be capable to potentialize the effects of physical therapy on upper limb rehabilitation of chronic stroke patients. Moreover, the study aims to investigate the pattern of physiological variables involved in the recovery of these patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individual physical therapy session.
详细描述
Patients will undergo behavioral and electrophysiological evaluation before, immediately after, 30 and 90 days after 10 sessions (follow ups). They will be submitted to the following evaluations: (i) Fugl-Meyer Scale; (ii) Jebsen-Taylor hand functional test; (iii) Box-Block test; (iv) Motor Activity Log - 30; (v) Geriatric Depression Scale - 15; (vi) Beck Depression Inventory; (vii) Stroke Impact Scale; (viii) Hand Grip Strength and (iv) Modified Ashworth Scale. In addition, one question of motivation will be answered by patients in different stages of the treatment: (i) motivation regarding their own life at the beginning and ending of the treatment; (ii) daily motivation at the beginning of each session; (iii) motivation of the last week at the fifth and tenth sessions; (iv) motivation regarding their own life at 30 and 90 days after the ending of the treatment. A visual scale will be used to assess patient's motivation through five potential answers: "very little", "little", "more or less", "very much" and "extremely".
Electrophysiological measures will be performed before and after each session and in follow ups.
Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil to determine motor cortex representation of first dorsal interosseus muscle (hotspot) and performed the following electrophysiological measures, in both cerebral hemispheres, to assess cortical activity: (i) Motor Evoked Potential (MEP); (ii) Active motor threshold (AMT) and (iii) Silent period (PS).
Evaluation of brain activity will be performed using single-pulse transcranial magnetic stimulation (TMS-p) only in Recife Centre. Magnetic stimulation (Neurosoft, Russia) will be applied through a figure-8 coil kept at a 45 degree angle relative to the sagittal line and pointed to the anterior region of the skull. Firstly, patients will be instructed to sit in a chair and to search a comfortable position. TMS-p will be applied in both motor cortex, healthy and injured, to determine the cortical representation of first dorsal interosseus muscle. The hotspot will be considered the most excitable area, with more intense motor evoked potential (MEP), measured by electromyography.
The following electrophysiological measures will be performed in both cerebral hemispheres to assess cortical activity:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or recurrent, ischemic or hemorrhagic stroke, confirmed by computed tomography or magnetic resonance imaging
- •Chronic Stroke (> 12 months)
- •Sensorimotor sequelae in an upper limb due to stroke
- •Score ≥ 18 at Folstein Mini Mental State Examination
- •Score ≥ 4 at Ashworth Scale
- •Minimal active wrist movement (flexion and extension)
- •At least one pinch movement
排除标准
- •Prior neurological diseases
- •Multiple brain lesions
- •Metal implant in the skull and face
- •Pacemaker
- •History of seizures
- •Pregnancy
- •Hemodynamic instability
- •Performing physical therapy elsewhere during the period of intervention
- •Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
- •Traumatic or orthopedic lesion limiting the range of motion of upper limb
结局指标
主要结局
Change in Fugl-Meyer assessment of paretic upper limb motor function
时间窗: baseline, after sessions, 30 and 90 days
Fugl-Meyer assessment is used to measure motor control recovery. It is a 226-point scoring system that includes the following sessions: range of motion, pain, sensation, motor function of upper and lower limbs, balance and coordination/velocity. We will apply only two sessions: upper limb motor function and coordination/velocity. These sessions totalize 66 points.The instrument provides a reliable and valid measure of specific motor function that is also sensitive to change.
次要结局
- Change from Motor Activity Log-30(baseline, after sessions, 30 and 90 days)
研究者
Kátia Monte-Silva
PhD
Universidade Federal de Pernambuco