Clinical trial NCT03909958: The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
electroacupuncture
Brain Structure and Function
Multi-mode Magnetic Resonance Imaging
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria:

1. Contraindication to MRI scanning such as metal in the body, pacemaker
2. Severe structural asymmetry or lesions in the brain
3. Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints
4. With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness
5. With severe primary diseases such as heart, liver, kidney and hematopoietic system
6. Patients with SCI due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc.
7. Pregnancy

Primary outcomes:
measure: Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI)
timeFrame: Before intervention; the end of the 3rd month when treatment finished.
measure: Brain function data(Changes of ALFF value and FC value of the whole brain based on fMRI)
timeFrame: Before intervention; the end of the 3rd month when treatment finished.
Secondary outcomes:
measure: Change in ASIA (American Spinal Injury Association) grade
timeFrame: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.
measure: Change in Modified Ashworth Scale(MAS)
timeFrame: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.
measure: Change in Modified Barthel Index(MBI)
timeFrame: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Ruijie Ma, Dr.
role: PRINCIPAL_INVESTIGATOR
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