Pilot Study Investigating the Neuromodulatory Effects of Transcranial Alternating Current Stimulation (tACS) on Upper Limb Motor Rehabilitation in Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Upper Extremities Fugl-Meyer Assessment (UE-FMA)
研究概览
简要总结
This study tests whether a brain stimulation technique called tACS can help stroke patients recover movement in their affected arm.
Patients receive either real or fake brain stimulation three times a week for about a month (12 sessions total). During each session, they wear a cap with electrodes that deliver mild electrical currents tailored to their individual brain patterns, while researchers monitor their brain activity.
The study measures progress at three time points: before treatment, right after treatment, and one month later. Researchers use brain stimulation tests to check how well the brain controls muscles, and conduct physical tests to measure arm movement, muscle stiffness, and grip strength.
详细描述
This randomised, double-blinded clinical trial investigates whether transcranial alternating current stimulation (tACS) can improve upper limb motor recovery in chronic stroke patients.
Participants receive either active or sham tACS delivered three times weekly for 4-6 weeks (12 sessions total) using individualised stimulation frequencies. The intervention uses 1 mA peak-to-peak intensity with EEG monitoring before and after each session to track brain oscillation changes.
Assessments occur at baseline, immediately post-intervention, and one-month follow-up. Neurophysiological measures include transcranial magnetic stimulation evaluations of corticospinal excitability, motor thresholds, and intracortical inhibition. Clinical outcomes encompass the Upper Extremity Fugl-Meyer Assessment, Action Research Arm Test, Modified Ashworth Scale for spasticity, and handgrip strength measurements.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80 years old;
- •First ever stroke, at least 9 months after stroke onset;
- •Evidence of corticomotor excitability as manifested by a recordable Motor Evoked Potential from the ipsilesional Motor Cortex (M1) by TMS measurement.
- •Objectively documented motor weakness of the upper extremity as manifested by an Upper Extremity-Fugl-Meyer Assessment score <=55
排除标准
- •Patients with implants: cardiac, neural or medication implants; any electrically, magnetically or mechanically activated implant; brain medical devices; vascular clips or any other electrically sensitive support system in the brain; other metal implants inside the body that are contraindications of MRI scan;
- •Patients with a history of seizures; Patients with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy;
- •Patients with serious brain injury;
- •Patients showing damage of skin at sites of stimulation;
- •Patients with unstable or non-controlled neuropsychiatric illness;
- •Patients suffering from severe or frequent headaches;
- •Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia;
- •Sensorimotor disturbance due to other causes other than stroke;
研究组 & 干预措施
real tACS
tACS will be delivered at a maximum intensity of 1 mA (peak-to-peak) at a frequency corresponding to the individual peak motor imagery (MI) performance frequency.
干预措施: tACS (Device)
sham tACS
sham tACS mimics active stimulation by delivering short periods of current matching the active protocol) with brief ramp-up and ramp-down periods at the very beginning and end of the session to replicate initial skin tingling sensations.
干预措施: Sham (Device)
结局指标
主要结局
Upper Extremities Fugl-Meyer Assessment (UE-FMA)
时间窗: Week 0
UE-FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Upper Extremities Fugl-Meyer Assessment (UE-FMA)
时间窗: Week 6
UE-FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Upper Extremities Fugl-Meyer Assessment (UE-FMA)
时间窗: Week 10
UE-FMA is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
次要结局
- Action Research Arm test (ARAT)(Week 0)
- Action Research Arm test (ARAT)(Week 6)
- Action Research Arm test (ARAT)(Week 10)
- handgrip strength(Week 0)
- handgrip strength(Week 6)
- handgrip strength(Week 10)
- peak-to-peak amplitude of motor evoked potential (MEP)(Week 0)
- peak-to-peak amplitude of motor evoked potential (MEP)(Week 6)
- peak-to-peak amplitude of motor evoked potential (MEP)(Week 10)