tDCS Guided by Interhemispheric Assimetry Level on Upper Limb Rehabilitation of Post Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Fugl Meyer assesment of paretic upper limb motor function
研究概览
简要总结
In this study, it is wondered whether cortical excitability level could predict/direct the use of transcranial direct current stimulation combined with physical therapy on upper limb rehabilitation of post stroke patients. Furthermore, the study aims to correlate the motor recovery with cortical excitability level. For this purpose, after basal evaluation, patients will be classified according motor function evaluated by Fugl Meyer in following categories: (ii) moderate: more than 19 points on Fulg Meyer (ii) severe: less than 19 points on Fulg Meyer.
详细描述
After given prior informed consent, volunteers will be classified and randomized using a website (randomization.com) by a non-involved researcher. At study beginning, volunteers will be evaluated through structured questionnaire. They will be submitted to the following evaluations: (i) Fugl-Meyer Scale; (ii) Motor Activity Log - 30; (iii) Functional independence measure; (iv) Patient Global Impression of Change Scale.
tDCS - tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitabilityquestionnaire will be applied.
Primary outcome measure Change in Fugl Meyer assesment of paretic upper limb motor function (time frame: baseline, before 6 session, after 10 sessions (10 days).
Fugl Meyer assesment 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, coordination and velocity. We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points.
Secondary outcome measures Cortical excitabilit level it will be evaluated through single pulse transcranial magnetic stimulation paradigms (Neurosoft, Russia). Initially, rest motor threshold (RMT) will be determined by finding the lowest stimulator output that elicit motor evoked potential (MEP) around 50 μV (TMS Motor Threshold Assessment Tool -MTAT 2.0 - USA). For RMT measure, a figure-eight coil connected to the magnetic stimulator held manually at 45 degrees from the midline, will be placed over the right primary motor cortex of lesioned and non lesioned hemisphere (C3 and/or C4 - 10/20 System). After, motor evoked potential will be evaluet by 20 pulses firing with 120% of RMT.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 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 (> 3 months)
- •Sensorimotor sequelae in an upper limb due to stroke
- •Score ≥ 18 at Folstein Mini Mental State Examination
排除标准
- •• Prior neurological diseases
- •Multiple brain lesions
- •Metal implant in the skull and face
- •Pacemaker
- •History of seizures
- •Pregnancy
- •Hemodynamic instability
- •Traumatic orthopedic injuries of upper limb that compromise the function
- •Altered medication for less than 3 months or who underwent botulinum toxin for less than 6 months
- •Performing physical therapy elsewhere during the period of intervention
- •Patients who do not present RMT in the healthy hemisphere.
结局指标
主要结局
Change in Fugl Meyer assesment of paretic upper limb motor function
时间窗: before 10 sessions, before 6 session and after 10 sessions - each session means 1 day
Fugl Meyer assesment 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, coordination and velocity. We will aplly only two sessions: upper limb motor function and coordination/velocity, these sessions totalize 66 points. Higher scores indicates better outcomes
次要结局
- Electroencephalography(before and after 10 sessions - each session means 1 day)
- Changes on Patient Global Impression of Change Scale(before the 6 session and after 10 sessions - each session means 1 day)
- Change from Functional independence measure(before and after 10 sessions - each session means 1 day)
- Cortical excitability level(before and after 10 sessions - each session means 1 day)
- Change from Motor acitivy log - 30(before and after 10 sessions - each session means 1 day)
研究者
Kátia Monte-Silva
Principal investigator
Universidade Federal de Pernambuco