Spinal Cord InjuriesNCT03909958
The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury
A study testing Electroacupuncture+Routine rehabilitation training Group and Routine rehabilitation training Group in people with Spinal Cord Injuries, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Electroacupuncture+Routine rehabilitation training Group and Routine rehabilitation training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
Ruijie Ma, Doctor, +86 18057102851, maria7878@sina.com
Kelin He, Master, +86 17764562993
About this study
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
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
- Being tested
- Electroacupuncture+Routine rehabilitation training Group, Routine rehabilitation training Group
- Keywords
- spinal cord injury, electroacupuncture, Brain Structure and Function, Multi-mode Magnetic Resonance Imaging
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture+Routine rehabilitation training GroupOther
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture+Routine rehabilitation training Group | Other | 42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training. Receives: Other: Electroacupuncture+Routine rehabilitation training Group |
| Routine rehabilitation training Group | Other | 42 patients will receive simple routine rehabilitation training. Receives: Behavioral: Routine rehabilitation training Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before intervention; the end of the 3rd month when treatment finished.
Secondary outcomes (3)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Before intervention; after 6 weeks of treatment;the end of the 3rd month when treatment finished;fellow-up period at the 6th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start26 Nov 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Ruijie Ma, Dr., Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909958
- Sponsor's protocol ID
- 2019ZZ013
- Status last verified
- Sep 2020
- First submitted
- 8 Apr 2019
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21488582National 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.
PubMed 23433327Heo 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.
PubMed 23476688Rekand 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.
PubMed 22562333Shin 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.
PubMed 19942112Buss 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.
PubMed 14534158Hains 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.
PubMed 12794736Kim 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.
PubMed 16443221Wu 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.
PubMed 25122899Altamura 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.
PubMed 29223329Saricicek 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.
PubMed 26233321Hutton 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.
PubMed 18325790Benetti 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.
PubMed 24084578Freund 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.
PubMed 21586596Jurkiewicz 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.
PubMed 16534122
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03909958
- Acronym / sponsor ID
- 2019ZZ013
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, electroacupuncture, Brain Structure and Function, Multi-mode Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture+Routine rehabilitation training Group | Other | Other: Electroacupuncture+Routine rehabilitation training Group42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training. |
| Routine rehabilitation training Group | Other | Behavioral: Routine rehabilitation training Group42 patients will receive simple routine rehabilitation training. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture+Routine rehabilitation training GroupElectroacupuncture： 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. | Other | Electroacupuncture+Routine rehabilitation training Group |
| Routine rehabilitation training GroupRoutine 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. | Behavioural | Routine rehabilitation training Group |
Primary outcome
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Background: PubMed 21488582Hunter 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.
- Background: PubMed 23433327National 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.
- Background: PubMed 23476688Heo 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.
- Background: PubMed 22562333Rekand 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.
- Background: PubMed 19942112Shin 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.
- Background: PubMed 14534158Buss 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.
- Background: PubMed 12794736Hains 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.
- Background: PubMed 16443221Kim 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.
- Background: PubMed 25122899Wu 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.
- Background: PubMed 29223329Altamura 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.
- Background: PubMed 26233321Saricicek 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.
- Background: PubMed 18325790Hutton 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruijie Ma, Dr. principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture+Routine rehabilitation training Group and Routine rehabilitation training Group in people with Spinal Cord Injuries, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruijie Ma, Dr. (+86 18057102851, maria7878@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909958, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.