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

Brain Ischemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03712085
• Other study ID #: YN2018HK03
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Hongxia Chen, Master
• Phone: 020-39318381
• Email: chx2004[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

1. First onset stroke, Left hemiplegia, Right-handed,and diagnosed by brain CT or MRI;

2. Age 35 to 75 years old;

3. Course of disease 0.5 to 3 months with stable vital signs;

4. No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;

5. Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is ? or V ,Fugl-Meyer Motor Assessment score of upper limb 20-50 point;

6. Agree to sign the informed consent;

7. Unilateral neglect.

Exclusion Criteria:

1. Recurrent stroke,subarachnoid hemorrhage, brain tumors patients;

2. Contraindication to undergo a 3T MR imaging;

3. Claustrophobia;

4. Have severe heart, hepatic or renal failure;

5. Don' t cooperate with the treatment;

6. Have participated in other clinical trails recently.

Related Conditions & MeSH terms

• Abdominal Acupuncture
• Brain Ischemia
• Electrophysiology of Neuromuscular
• Hemiplegic Patients With Stroke
• Image Science
• Ischemia
• Stroke

Intervention

Other:
• Abdominal acupuncture
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 acupuncture
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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Chinese University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
Primary	Motor function of muscles	Common measures of sEMG will be tested. See the study protocol for details.	SEMG will be tested before and after 4 weeks treatment,twice totally.
Secondary	Wolf Motor Function Test	See the study protocol for details	Before treatment, 2 weeks and 4 weeks after treatment, 3 times totally.
Secondary	Brunnstrom staging of upper limb movement	See the study protocol for details	Before treatment, 2 weeks and 4 weeks after treatment, 3 times totally.
Secondary	Fugl-Meyer Motor Assessment of upper limb	See the study protocol for details	Before treatment, 2 weeks and 4 weeks after treatment, 3 times totally.
Secondary	Modified Barthel Index,MBI	See the study protocol for details	Before treatment, 2 weeks and 4 weeks after treatment, 3 times totally.