Repeated Transcranial Magnetic Stimulation (rTMS) Promotes Neural Function Recovery in Patients With Ischemic Stroke by Affecting Local Cerebral Blood Flow and Brain Network
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in patient motor function
研究概览
简要总结
The goal of this clinical trial is to learn if transcranial magnetic stimulation(rTMS) can improve neurological rehabilitation in patients with acute ischemic stroke. The main questions it aims to answer are:
Can rTMS Promote Recovery of Limb Impairment in Patients with Acute Ischemia? Can rTMS Cause Changes in the Functional Connections of Brain Networks in Patients?
Researchers will compare rTMS therapy to non-stimulation therapy to see if rTMS is effective in promoting neurological recovery from ischemic stroke.
Participants will:
Receive rTMS or sham stimulation with LF-rTMS on the contralateral M1 of the brain lesion for 20 minutes, 1200 pulses, 120% RMT, and a treatment period of 5 days； Be evaluated on a scale before and after 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age range is 18~75 years old
- •Meet the diagnostic criteria of China Acute Ischaemic Stroke Diagnosis and Treatment Guidelines 2018 and confirmed by head CT or MRI scanning
- •Acute stage of the disease <14 days and stable condition
- •Stroke patients with only unilateral limb involvement (without bilateral cerebrovascular lesions)
- •Patients with upper limb muscle strength ≥ grade 3, able to perform fNIRS tasks with the patient.
- •Subjects were right-handed
- •Participants give their informed consent and sign an informed consent form
排除标准
- •Those who have metal implants or any electronic devices in their body
- •Those with previous epilepsy or mental abnormality.
- •Combined with serious heart, liver, lung and other important organ failure
- •Those who have brain haemorrhage or bleeding tendency.
- •Deteriorating condition, new cerebral infarction or secondary cerebral haemorrhage.
- •Patients with history of craniocerebral trauma and craniocerebral surgery.
- •Those with severe cognitive and communication disorders who are unable to cooperate -
结局指标
主要结局
Improvement in patient motor function
时间窗: Before patient treatment and 5 days after patient treatment
Fugl-Meyer assessment scale，FMA Score: Minimum: 0 points, Maximum: 100 points The higher the score, the better the limb function.
次要结局
- Altered functional connectivity of brain networks in patients(Patient before and after treatment on the first and fifth day of treatment and during rTMS treatment)