Individualized Closed-Loop Neuromodulation With Repetitive Transcranial Magnetic Stimulation Synchronized Task Training for Upper Limb Motor Dysfunction in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
研究概览
简要总结
The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of online rTMS intervention methods. The main questions it aims to answer are:
- Does individualized rTMS precise target combined with motor training improve upper limb motor rehabilitation in patients？
- Does individualized rTMS precise target combined with motor training enhance the upper limb motor rehabilitation ability in stroke patients by strengthening the functional coupling of the motor circuit to achieve functional reorganization of the brain network ?
Researchers will compare individualized online rTMS to non-individualized online and individualized sham stimulation in stroke patients to see if individualized online rTMS works to alleviate motor dysfunction in this randomized，sham-controlled, double-blind trial.
Participants will:
- randomized to one group(individualized online, non-individualized online or sham);
- receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
- receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
- conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
- •The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
- •Motor evoked potentials(MEPs) of First Dorsal Interosseous Muscle（FDI）or Abductor Pollicis Brevis Muscle (APB) is negative in ipsilesional hemisphere.
- •The age is between 20 and 80 years old.
- •The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
- •There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
- •There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures).
- •The patient or guardian agrees to sign the informed consent form.
排除标准
- •Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
- •Those with a history of aphasia, severe cognitive impairment or mental illness;
- •Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
- •Those with severe visual or hearing impairments, unable to communicate normally;
- •People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
研究组 & 干预措施
Individualized online stimulation
The individualized online stimulation group will calculate precise targets based on the collected multimodal MRI (structural images, resting-state/task-state functional images, and diffusion tensor imaging), plan the coil position and placement angle of TMS through electric field simulation, and achieve individualized intervention. At the same time, when patients receive TMS treatment, they are paired with specific upper limb motor tasks. When the task starts autonomously, TMS stimulation is triggered by acceleration-EMG feedback. When the task stops or is completed, TMS stimulation also stops immediately according to the acceleration-EMG feedback to achieve real-time effects.
干预措施: Individualized online stimulation (Device)
Non-individualized online stimulation
In the non-individualized online stimulation group, patients receive TMS treatment synchronized with task training. However, the targeting uses traditional positioning methods, i.e., determining the target with a positioning cap instead of precise target localization.
干预措施: Non-individualized online stimulation (Device)
Sham stimulation
In the individualized online sham stimulation group, patients receive TMS treatment combined with specific tasks. The stimulation targets are the same as those in the online stimulation group, all determined by precise target localization, except that a sham stimulation coil is used for TMS stimulation.
干预措施: Sham stimulation (Device)
结局指标
主要结局
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
时间窗: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention
The Fugl-Meyer Assessment (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. The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance).
次要结局
- Action Research Arm Test (ARAT)(Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention)
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention)
- Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)(Baseline; Day 6 during 2-week intervention; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention)
- The average completion time for baseline tasks(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day7, Day 8, Day 9, Day 10 during TMS intervention)
- Modified Barthel Index (MBI)(Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention)