Brain IschemiaNCT03712085
Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke
A study testing Abdominal acupuncture in people with Brain Ischemia and Hemiplegic Patients With Stroke, run by Guangzhou University of Traditional Chinese Medicine at 2 sites in 2 countries.
Trial summary
Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Brain Ischemia, Hemiplegic Patients With Stroke, Image Science
- What is being tested?
- Abdominal acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jan 2019to Dec 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
- Age 35 to 75 years old;
- Course of disease 0.5 to 3 months with stable vital signs;
- No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
- Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
- Agree to sign the informed consent;
- Unilateral neglect.
Who cannot join
- Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
- Contraindication to undergo a 3T MR imaging;
- Claustrophobia;
- Have severe heart, hepatic or renal failure;
- Don' t cooperate with the treatment;
- Have participated in other clinical trails recently.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120
Hongxia P Chen, Master, 020-81887233 ext. 02039318381, chx2004@126.com
Ruihuan P Pan, Doctor, 020-81887233 ext. 02081887233, panruihuan@163.com
Hong Kong1 site, 1 recruiting
- Not yet recruiting
The Chinese University of Hong Kong
Hong Kong
Vincent Chi-Kwan Cheung, Doctor, (852)59270597, vckc@cuhk.edu.cn
About this study
Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.
- Conditions
- Brain Ischemia, Hemiplegic Patients With Stroke, Image Science, Electrophysiology of Neuromuscular, Abdominal Acupuncture
- Being tested
- Abdominal acupuncture, Sham abdominal acupuncture
- Keywords
- Functional magnetic resonance imaging（fMRI）, Surface electromyography （sEMG）, Abdominal acupuncture, Brain Plasticity, Effects and mechanism
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal acupunctureOther
Abdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks.
Sham abdominal acupunctureOther
Also called Upper limb rehabilitation training
Sham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Active comparator | Abdominal acupuncture and upper limb rehabilitation training Receives: Other: Abdominal acupuncture |
| Treatment Group B | Sham comparator | Sham abdominal acupuncture and upper limb rehabilitation training Receives: Other: Sham abdominal acupuncture |
| Control Group | No intervention | Upper limb rehabilitation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The integrity of the corticospinal tract
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
Measured: Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
Motor function of muscles
Common measures of sEMG will be tested. See the study protocol for details.
Measured: SEMG will be tested before and after 4 weeks treatment,twice totally.
Secondary outcomes (4)
Wolf Motor Function Test
See the study protocol for details
Measured: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Brunnstrom staging of upper limb movement
See the study protocol for details
Measured: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Fugl-Meyer Motor Assessment of upper limb
See the study protocol for details
Measured: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Modified Barthel Index，MBI
See the study protocol for details
Measured: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start15 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain IschemiaStudies 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Sponsor
- Investigators
- Hongxia Chen, Master, Principal investigator, Director of the rehabilitation departmentVincet Chi-kwan Cheung, Doctor, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712085
- Sponsor's protocol ID
- YN2018HK03
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke
- ClinicalTrials.gov ID
- NCT03712085
- Acronym / sponsor ID
- YN2018HK03
- Conditions
- Brain Ischemia, Hemiplegic Patients With Stroke, Image Science, Electrophysiology of Neuromuscular, Abdominal Acupuncture
- Keywords
- Functional magnetic resonance imaging（fMRI）, Surface electromyography （sEMG）, Abdominal acupuncture, Brain Plasticity, Effects and mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Oct 2018 (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.
Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Active comparator | Other: Abdominal acupunctureAbdominal acupuncture and upper limb rehabilitation training |
| Treatment Group B | Sham comparator | Other: Sham abdominal acupunctureSham abdominal acupuncture and upper limb rehabilitation training |
| Control Group | No intervention | –Upper limb rehabilitation only |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
- Age 35 to 75 years old;
- Course of disease 0.5 to 3 months with stable vital signs;
- No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
- Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
Key exclusion criteria (6 listed)
- Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
- Contraindication to undergo a 3T MR imaging;
- Claustrophobia;
- Have severe heart, hepatic or renal failure;
- Don' t cooperate with the treatment;
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 |
|---|---|---|
| Abdominal acupunctureAbdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks. | Other | Treatment Group A |
| Sham abdominal acupunctureAlso: Upper limb rehabilitation trainingSham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min. | Other | Treatment Group B |
Primary outcome
The integrity of the corticospinal tract
Time frame: Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
Motor function of muscles
Time frame: SEMG will be tested before and after 4 weeks treatment,twice totally.
Common measures of sEMG will be tested. See the study protocol for details.
4 secondary outcomes
Wolf Motor Function Test
Time frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Brunnstrom staging of upper limb movement
Time frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Fugl-Meyer Motor Assessment of upper limb
Time frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Modified Barthel Index，MBI
Time frame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Hongxia Chen, Master principal investigator
Director of the rehabilitation department
Vincet Chi-kwan Cheung, Doctor principal investigator
Assistant professor
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal acupuncture in people with Brain Ischemia and Hemiplegic Patients With Stroke, run by Guangzhou University of Traditional Chinese Medicine at 2 sites in 2 countries.
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 7 inclusion and 6 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. 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. Some participants in this study may receive a placebo. 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 Hongxia Chen, Master (020-39318381 ext. +8613609031028, chx2004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The integrity of the corticospinal tract (time frame: Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.). 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?
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 9 Jul 2019.