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

Primary Purpose

Spinal Cord Injuries

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Electroacupuncture+Routine rehabilitation training Group

Routine rehabilitation training Group

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, electroacupuncture, Brain Structure and Function, Multi-mode Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria:

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

Sites / Locations

The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Electroacupuncture+Routine rehabilitation training Group

Routine rehabilitation training Group

Arm Description

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

42 patients will receive simple routine rehabilitation training.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change 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.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.

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.

Change in Modified Barthel Index(MBI)

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.

Full Information

NCT ID

NCT03909958

First Posted

April 8, 2019

Last Updated

September 15, 2020

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03909958

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 26, 2019 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture+Routine rehabilitation training Group

Arm Type

Other

Arm Description

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

Arm Title

Routine rehabilitation training Group

Arm Type

Other

Arm Description

42 patients will receive simple routine rehabilitation training.

Intervention Type

Other

Intervention Name(s)

Electroacupuncture+Routine rehabilitation training Group

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Routine rehabilitation training Group

Intervention Description

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 Measure Information:

Title

Brain structure data(Changes of gray and white matter volume on whole brain based on fMRI)

Description

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.

Time Frame

Before intervention; the end of the 3rd month when treatment finished.

Title

Brain function data(Changes of ALFF value and FC value of the whole brain based on fMRI)

Description

Time Frame

Before intervention; the end of the 3rd month when treatment finished.

Secondary Outcome Measure Information:

Title

Change in ASIA (American Spinal Injury Association) grade

Description

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.

Title

Change in Modified Ashworth Scale(MAS)

Description

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.

Title

Change in Modified Barthel Index(MBI)

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruijie Ma, Dr.

Phone

+86 18057102851

maria7878@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruijie Ma, Dr.

Organizational Affiliation

The Third Affiliated hospital of Zhejiang Chinese Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Third Affiliated Hospital of Zhejiang Chinese Medical University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ruijie Ma, Doctor

Phone

+86 18057102851

maria7878@sina.com

First Name & Middle Initial & Last Name & Degree

Kelin He, Master

Phone

+86 17764562993

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

21488582

Citation

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.

Results Reference

background

PubMed Identifier

23433327

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. No abstract available.

Results Reference

background

PubMed Identifier

23476688

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.

Results Reference

background

PubMed Identifier

22562333

Citation

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.

Results Reference

background

PubMed Identifier

19942112

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.

Results Reference

background

PubMed Identifier

14534158

Citation

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.

Results Reference

background

PubMed Identifier

12794736

Citation

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.

Results Reference

background

PubMed Identifier

16443221

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

Results Reference

background

PubMed Identifier

25122899

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.

Results Reference

background

PubMed Identifier

29223329

Citation

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.

Results Reference

background

PubMed Identifier

26233321

Citation

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.

Results Reference

background

PubMed Identifier

18325790

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.

Results Reference

background

PubMed Identifier

24084578

Citation

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.

Results Reference

background

PubMed Identifier

21586596

Citation

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.

Results Reference

background

PubMed Identifier

16534122

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. doi: 10.1212/01.wnl.0000201276.28141.40.

Results Reference

background

PubMed Identifier

26079978

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.

Results Reference

background

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

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