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The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03909958
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Zhejiang Administration of Traditional Chinese Medicine Bureau
Information provided by (Responsible Party):
Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Electroacupuncture+Routine rehabilitation training Group Behavioral: Routine rehabilitation training Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Electroacupuncture+Routine rehabilitation training Group
42 patients will receive both electroacupuncture(HANS100A)therapy and routine rehabilitation training.
Other: Electroacupuncture+Routine rehabilitation training Group

Electroacupuncture: Major acupoints: Jiaji points. With urinary and stool dysfunction:+Shenshu (BL23) ,Huiyang(BL35).

Localization:Jiaji points of the upper 1 and the lower 1 segment of the Spinal cord injury plane, a total of 4 points.

Operation: Insert Jiaji points By using Hwato-brand disposable acupuncture needles(0.30mm*50mm), with 0.5 inch from the median line and a depth of 50 to 60mm with perpendicular insertion.Then, participants will receive electroacupuncture treatment by connecting Han's pain irritant instrument (HANS100A) for 30min with the stimulation frequency of 2 /100 Hz and intensity of 1-2mA. Once a day, 5 days a week and rest 2 days, a week is one course and the duration need 12 courses.

Routine rehabilitation training:

Same as Routine rehabilitation training Group.


Routine rehabilitation training Group
42 patients will receive simple routine rehabilitation training.
Behavioral: Routine rehabilitation training Group

Routine rehabilitation training:

Participants with good spinal stability will receive sitting training as early as possible, and will carry out standing training if participants had no adverse reactions (postural hypotension, etc.) after sitting training. Muscle strength training will be performed in recovery phase, and functional movement training will be selected according to participants' conditions. Functional movement training and transfer training will be performed for 20min each time and once a day;Standing and walking training, 2 times a day, 30min each time.





Primary Outcome Measures :
  1. Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI) [ Time Frame: 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.

  2. Brain function data(Changes of ALFF value and FC value of the whole brain based on fMRI) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in ASIA (American Spinal Injury Association) grade [ Time Frame: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month. ]

    To assess the motor function and the sensory function. The motor function will be evaluated according to the scores of five key muscles and muscle strength in both lower limbs.This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-25 for each extremity, with maximum scores of 50 for the upper limbs and 50 for the lower limbs.

    The sensory function will be evaluated according to the scores of bilateral pain sensation and tactile sensation in 14 key sensory points in both lower limbs. This score can reflect the degree of neurological impairment associated with the SCI, with lower score indicating greater impairment. Score ranges from 0-56 points each for light touch and pin prick (sharp/dull discrimination) modalities, with a maximum total score of 112 points per side of the body.


  2. Change in Modified Ashworth Scale(MAS) [ Time Frame: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month. ]

    To assess the muscle tone.MAS grades as follows:

    0: No increase in muscle tone.1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is(are) moved in flexion or extension.1+: Slight increase in muscle tone, manifested by a catch followed by minimal resistance through the remainder of the range of motion but the affected part(s) is(are) easily moved.2: More marked increase in muscle tone through most of the range of movement, but the affected part(s) is easily moved.3: Considerable increases in muscle tone, passive movement difficult.4: Affected part(s) is (are) rigid in flexion or extension.


  3. Change in Modified Barthel Index(MBI) [ Time Frame: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month. ]
    To assess the ability of the patient to perform daily activities.It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities.Scale range: 0-100.Higher score means better function and less dependence.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18 to 55;
  2. Subacute phase(14-30 days after the onset of SCI);
  3. Cervical Spinal cord injuries classified as B,C, or D on the ASIA impairment scale(Incomplete spinal cord injury);
  4. With grade 1-3 muscle strength of both lower limbs;
  5. Right-handed;
  6. Patients who submitted written informed consent.

Exclusion Criteria:

  1. Contraindication to MRI scanning such as metal in the body, pacemaker;
  2. Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints;
  3. With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness;
  4. With severe primary diseases such as heart, liver, kidney and hematopoietic system;
  5. SCI due to other causes(myelomyelitis, multiple sclerosis, intraspinal tumors, etc.);
  6. Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909958


Contacts
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Contact: Ruijie Ma, Dr. +86 18057102851 maria7878@sina.com

Locations
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China, Zhejiang
The Third Affiliated Hospital of Zhejiang Chinese Medical University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Ruijie Ma, Doctor    +86 18057102851    maria7878@sina.com   
Contact: Kelin He, Master    +86 17764562993      
Sponsors and Collaborators
The Third Affiliated hospital of Zhejiang Chinese Medical University
Zhejiang Administration of Traditional Chinese Medicine Bureau
Investigators
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Principal Investigator: Ruijie Ma, Dr. The Third Affiliated hospital of Zhejiang Chinese Medical University

Publications:

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Responsible Party: Ruijie Ma, Professor,Vice president of the Third Affiliated hospital of Zhejiang Chinese Medical University, The Third Affiliated hospital of Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier: NCT03909958     History of Changes
Obsolete Identifiers: NCT03909087
Other Study ID Numbers: 2019ZZ013
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University:
spinal cord injury
electroacupuncture
Brain Structure and Function
Multi-mode Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System