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临床试验/NCT04617366
NCT04617366Unknown不适用

Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Fugl-Meyer motor function score of upper limb

研究概览

简要总结

Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.

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 (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged 40-79 years;
  • •Patients with first-onset subcortical infarcts within1 to 3 weeks after onset;
  • •TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand;
  • •Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
  • •The patient or its authorized agent signs the informed consent form.

排除标准

  • •Previous seizures;
  • •Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
  • •Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.

研究组 & 干预措施

Individualized rTMS strategy

Experimental

The individualized strategy will adjust the rTMS parameters promptly based on the results of fNIRS. This arm selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS.

干预措施: Individualized rTMS strategy (Other)

Traditional rTMS strategy

Active Comparator

The control group will always be given low-frequency rTMS to contralesional M1.

干预措施: Traditional rTMS strategy (Other)

结局指标

主要结局

Fugl-Meyer motor function score of upper limb

时间窗: 3 months

The score range is 0-66 points, the higher the score, the better the motor function of upper limb.

次要结局

  • Barthel index(3 months)
  • Lateralization index (LI)(3 months)
  • Brain functional connection network(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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