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

Spinal Cord Injuries Clinical Trial

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 Magnetic Resonance Imaging.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03909087
• Other study ID #: 2019-02
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2019
• Source: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Contact: Ruijie Ma, Dr.
• Phone: +86 18057102851
• Email: maria7878[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

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.

Locations

Country	Name	City	State
China	the Third affilliated Hospital of Zhejiang Chinese Medicine University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University	Zhejiang Administration of Traditional Chinese Medicine Bureau

Country where clinical trial is conducted

China, 

References & Publications (16)

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Hains BC, Black JA, Waxman SG. Primary cortical motor neurons undergo apoptosis after axotomizing spinal cord injury. J Comp Neurol. 2003 Jun 9;462(3):328-41. — View Citation

Heo I, Shin BC, Kim YD, Hwang EH, Han CW, Heo KH. Acupuncture for spinal cord injury and its complications: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2013;2013:364216. doi: 10.1155/2013/364216. Epub 2013 Feb 17. — View Citation

Hunter Revell SM. Symptom clusters in traumatic spinal cord injury: an exploratory literature review. J Neurosci Nurs. 2011 Apr;43(2):85-93. Review. — View Citation

Hutton C, De Vita E, Ashburner J, Deichmann R, Turner R. Voxel-based cortical thickness measurements in MRI. Neuroimage. 2008 May 1;40(4):1701-10. doi: 10.1016/j.neuroimage.2008.01.027. Epub 2008 Feb 1. — View Citation

Jurkiewicz MT, Crawley AP, Verrier MC, Fehlings MG, Mikulis DJ. Somatosensory cortical atrophy after spinal cord injury: a voxel-based morphometry study. Neurology. 2006 Mar 14;66(5):762-4. — View Citation

Kim BG, Dai HN, McAtee M, Vicini S, Bregman BS. Remodeling of synaptic structures in the motor cortex following spinal cord injury. Exp Neurol. 2006 Apr;198(2):401-15. Epub 2006 Jan 26. — View Citation

Ma R, Liu X, Clark J, Williams GM, Doi SA. The Impact of Acupuncture on Neurological Recovery in Spinal Cord Injury: A Systematic Review and Meta-Analysis. J Neurotrauma. 2015 Dec 15;32(24):1943-57. doi: 10.1089/neu.2014.3866. Epub 2015 Aug 28. Review. — View Citation

National Spinal Cord Injury Statistical Center. Spinal cord injury facts and figures at a glance. J Spinal Cord Med. 2013 Jan;36(1):1-2. doi: 10.1179/1079026813Z.000000000136. — View Citation

Rekand T, Hagen EM, Grønning M. Chronic pain following spinal cord injury. Tidsskr Nor Laegeforen. 2012 Apr 30;132(8):974-9. doi: 10.4045/tidsskr.11.0794. Review. English, Norwegian. — View Citation

Sariçiçek A, Yalin N, Hidiroglu C, Çavusoglu B, Tas C, Ceylan D, Zorlu N, Ada E, Tunca Z, Özerdem A. Neuroanatomical correlates of genetic risk for bipolar disorder: A voxel-based morphometry study in bipolar type I patients and healthy first degree relatives. J Affect Disord. 2015 Nov 1;186:110-8. doi: 10.1016/j.jad.2015.06.055. Epub 2015 Jul 26. — View Citation

Shin BC, Lee MS, Kong JC, Jang I, Park JJ. Acupuncture for spinal cord injury survivors in Chinese literature: a systematic review. Complement Ther Med. 2009 Oct-Dec;17(5-6):316-27. doi: 10.1016/j.ctim.2009.09.001. Epub 2009 Oct 21. Review. — View Citation

Wu J, Zhao Z, Sabirzhanov B, Stoica BA, Kumar A, Luo T, Skovira J, Faden AI. Spinal cord injury causes brain inflammation associated with cognitive and affective changes: role of cell cycle pathways. J Neurosci. 2014 Aug 13;34(33):10989-1006. doi: 10.1523/JNEUROSCI.5110-13.2014. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI)	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.	Before intervention; the end of the 3rd month when treatment finished.
Primary	Brain function data(Changes of ALFF value and FC value of the whole brain based on fMRI)	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.	Before intervention; the end of the 3rd month when treatment finished.
Secondary	Functional improvement in ASIA (American Spinal Injury Association) grade	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, and 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. The higher the score, the better the curative effect.	Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.
Secondary	Change in Modified Ashworth Scale(MAS)	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.	Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.
Secondary	Change in Modified Barthel Index(MBI)	To assess the ability of the patient to perform daily activities.Higher score means better function and less dependence.	Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.