The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes in Patients With Spinal Cord Injury:A Randomized Controlled Study Based on Multi-mode MRI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI)
研究概览
简要总结
Spinal cord injury (SCI) is a kind of severe disease with high morbidity and complications. At present, electroacupuncture has certain advantages in treating motor sensory dysfunction, neuropathologic pain, neurogenic bladder and intestinal dysfunction after spinal cord injury. However, previous clinical studies of acupuncture neglected the brain, which is closely related to the structure and function of spinal cord.So,the aim of this study is to observe and analyse the impact of the changes of gray and white matter volume on whole brain and brain functional re-establish,to reveal the neuroimaging mechanism of improving the motor sensory functions of patients with spinal cord injury, and to provide a theoretical basis for the clinical application of electroacupuncture.
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
- None
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
- •1.Aged 18-75 years no matter the gender 2.14 days to 3 months after the onset of SCI 3.Patients with cervical, thoracic or lumbar spinal cord injuries 4.SCI classified as B, C, or D grade on the ASIA impairment scale(AIS), that is incomplete SCI (iSCI) 5.Patients with grade 1-3 muscle strength of lower limbs 6.Right-handed 7.Patients who submitted written informed consent
排除标准
- •Contraindication to MRI scanning such as metal in the body, pacemaker
- •Severe structural asymmetry or lesions in the brain
- •Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints
- •With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness
- •With severe primary diseases such as heart, liver, kidney and hematopoietic system
- •Patients with SCI due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc.
结局指标
主要结局
Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI)
时间窗: Before intervention; the end of the 3rd month when treatment finished.
The 3D MPRAGE image data collected by fMRI will be recorded and exported on a CD, and then will be processed and analyzed by VBM8.
Brain function data(Changes of ALFF value and FC value of the whole brain based on fMRI)
时间窗: Before intervention; the end of the 3rd month when treatment finished.
The REST fMRI image data will be recorded and exported to a CD, and then will be processed and analyzed with REST software and seed point method to calculate the ALFF value and FC value of the whole brain.
次要结局
- Change in Modified Barthel Index(MBI)(Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.)
- Change in ASIA (American Spinal Injury Association) grade(Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.)
- Change in Modified Ashworth Scale(MAS)(Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.)
研究者
Ruijie Ma
Professor,Vice president of the Third Affiliated hospital of Zhejiang Chinese Medical University
The Third Affiliated hospital of Zhejiang Chinese Medical University