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

NCT03909958 | Unknown

• 1 other identifier: 2019ZZ013
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury; electroacupuncture; Brain Structure and Function; Multi-mode Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (3)

• 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.

• 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.

Study Arms (2)

Electroacupuncture+Routine rehabilitation training Group

OTHER

42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training.

Other: Electroacupuncture+Routine rehabilitation training Group

Routine rehabilitation training Group

OTHER

42 patients will receive simple routine rehabilitation training.

Behavioral: Routine rehabilitation training Group

Interventions

Electroacupuncture+Routine rehabilitation training Group OTHER

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.

Electroacupuncture+Routine rehabilitation training Group

Routine rehabilitation training Group BEHAVIORAL

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.

Routine rehabilitation training Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• Pregnancy

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (16)

• Hunter Revell SM. Symptom clusters in traumatic spinal cord injury: an exploratory literature review. J Neurosci Nurs. 2011 Apr;43(2):85-93. doi: 10.1097/jnn.0b013e31820c2533.

  PMID: 21488582 BACKGROUND

• 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. No abstract available.

  PMID: 23433327 BACKGROUND

• 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.

  PMID: 23476688 BACKGROUND

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

  PMID: 22562333 BACKGROUND

• 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.

  PMID: 19942112 BACKGROUND

• Buss A, Brook GA, Kakulas B, Martin D, Franzen R, Schoenen J, Noth J, Schmitt AB. Gradual loss of myelin and formation of an astrocytic scar during Wallerian degeneration in the human spinal cord. Brain. 2004 Jan;127(Pt 1):34-44. doi: 10.1093/brain/awh001. Epub 2003 Oct 8.

  PMID: 14534158 BACKGROUND

• 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. doi: 10.1002/cne.10733.

  PMID: 12794736 BACKGROUND

• 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. doi: 10.1016/j.expneurol.2005.12.010. Epub 2006 Jan 26.

  PMID: 16443221 BACKGROUND

• 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.

  PMID: 25122899 BACKGROUND

• Altamura AC, Maggioni E, Dhanoa T, Ciappolino V, Paoli RA, Cremaschi L, Prunas C, Orsenigo G, Caletti E, Cinnante CM, Triulzi FM, Dell'Osso B, Yatham L, Brambilla P. The impact of psychosis on brain anatomy in bipolar disorder: A structural MRI study. J Affect Disord. 2018 Jun;233:100-109. doi: 10.1016/j.jad.2017.11.092. Epub 2017 Nov 29.

  PMID: 29223329 BACKGROUND

• Saricicek A, Yalin N, Hidiroglu C, Cavusoglu B, Tas C, Ceylan D, Zorlu N, Ada E, Tunca Z, Ozerdem 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.

  PMID: 26233321 BACKGROUND

• 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.

  PMID: 18325790 BACKGROUND

• Benetti S, Pettersson-Yeo W, Hutton C, Catani M, Williams SC, Allen P, Kambeitz-Ilankovic LM, McGuire P, Mechelli A. Elucidating neuroanatomical alterations in the at risk mental state and first episode psychosis: a combined voxel-based morphometry and voxel-based cortical thickness study. Schizophr Res. 2013 Nov;150(2-3):505-11. doi: 10.1016/j.schres.2013.08.030. Epub 2013 Sep 29.

  PMID: 24084578 BACKGROUND

• Freund P, Weiskopf N, Ward NS, Hutton C, Gall A, Ciccarelli O, Craggs M, Friston K, Thompson AJ. Disability, atrophy and cortical reorganization following spinal cord injury. Brain. 2011 Jun;134(Pt 6):1610-22. doi: 10.1093/brain/awr093. Epub 2011 May 17.

  PMID: 21586596 BACKGROUND

• 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. doi: 10.1212/01.wnl.0000201276.28141.40.

  PMID: 16534122 BACKGROUND

• 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.

  PMID: 26079978 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ruijie Ma, Dr.

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruijie Ma, Dr.

CONTACT

+86 18057102851; maria7878@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Vice president of the Third Affiliated hospital of Zhejiang Chinese Medical University

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: November 26, 2019
• Primary Completion: December 31, 2020
• Study Completion: August 31, 2021
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

CN (1)