A Multi-center, Randomized, Double-blind, Prospective, Superiority Clinical Trial to Evaluate the Safety and Effectiveness of Artificial Intelligence-based Customized Transcranial Direct Current Stimulation Using MR Images for Improving Finger Motor Function in Patients With Finger Paralysis Due to Subacute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Function Test
研究概览
简要总结
The goal of this clinical study is to evaluate whether AI-based customized transcranial direct current stimulation (tDCS) using MR images is more effective than sham stimulation in improving finger motor function in patients with finger paralysis caused by subacute stroke. The main questions it aims to answer are:
- Does AI-based customized tDCS improve finger motor function compared with sham stimulation?
- What medical problems or adverse events occur when participants receive AI-based customized tDCS?
Researchers will compare AI-based customized tDCS with sham stimulation (a look-alike stimulation that delivers no electrical current) to determine whether the intervention improves finger motor recovery in patients with subacute 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be eligible for this clinical trial:
- •Adults aged 19 years or older
- •Patients with stroke confirmed by brain imaging
- •Subacute stroke patients within 2 weeks to 3 months after stroke onset
- •Patients with unilateral upper-extremity paralysis
- •Upper-extremity Fugl-Meyer Assessment (FMA-UE, maximum score 66) score between 20 and 56
- •Participants who voluntarily provide written informed consent after receiving and understanding the study procedures and requirements
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •History of a condition affecting the function of the paralyzed arm
- •Inability to follow instructions or complete the study due to cognitive impairment or aphasia
- •Evidence of delirium, confusion, or other disorders of consciousness
- •Presence of uncontrolled medical or surgical conditions
- •Severe neurological disorders associated with major psychiatric conditions (e.g., major depressive disorder, schizophrenia, bipolar disorder, or dementia)
- •History of uncontrolled epilepsy (seizure disorder)
- •Contraindications to transcranial direct current stimulation (tDCS), including:
- •Scalp disease or metal materials at the electrode attachment site
- •Presence of a cardiac pacemaker or cochlear implant
- •Medical contraindications to MRI examination
- •Pregnant or breastfeeding women, or those planning pregnancy during the study period
- •Use of a stimulation device similar to the investigational device or participation in a related clinical study within the past 1 year
- •Individuals judged by the investigator to be medically or ethically unsuitable for participation in this clinical study
结局指标
主要结局
Fugl-Meyer Function Test
时间窗: Baseline, At 2 weeks from baseline
The Fugl-Meyer Assessment (FMA) is a validated clinical scale used to evaluate sensorimotor recovery in patients with post-stroke hemiplegia based on Brunnstrom stages of motor recovery. Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). In this study, the upper-extremity FMA will be used. The assessment includes items evaluating the shoulder, elbow, forearm, wrist, hand (fingers), coordination/speed, sensation, passive joint motion, and joint pain during passive movement, with a total score ranging from 0 to 126 points.
次要结局
- Fugl-Meyer Function Test(Baseline, At 1, 3, 4, 14 weeks from baseline)
- Wolf Motor Function Test(Baseline, At 1, 2, 3, 4, 14 weeks from baseline)
- Box and Blocks Test(Baseline, At 1, 2, 3, 4, 14 weeks from baseline)
- Korean version of Modified Barthel Index (K-MBI)(Baseline, At 1, 2, 3, 4, 14 weeks from baseline)
- Grip Strength(Baseline, At 1, 2, 3, 4, 14 weeks from baseline)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Baseline, At 2, 14 weeks from baseline)
- Motor-Evoked Potential (MEP)(Baseline, At 2 weeks from baseline)