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

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 Overview

• Status: Unknown
• Conditions: Brain Ischemia; Hemiplegic Patients With Stroke; Image Science; Electrophysiology of Neuromuscular; Abdominal Acupuncture
• Intervention / Treatment: Other: Abdominal acupuncture; Other: Sham abdominal acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Contact: Hongxia P Chen, Master; Phone Number: 02039318381 020-81887233; Email: chx2004@126.com
      • Contact: Ruihuan P Pan, Doctor; Phone Number: 02081887233 020-81887233; Email: panruihuan@163.com
      • Principal Investigator: Hongxia P Chen, Master
      • Sub-Investigator: Vincet Chi-kwan P Cheung, Doctor
      • Sub-Investigator: Ruihuan P Pan, Doctor
      • Sub-Investigator: Bo Liu, Master
      • Sub-Investigator: Youhua Guo, Master
      • Sub-Investigator: Zhijing Yang, Master
      • Sub-Investigator: Lechang Zhan, Master
      • Sub-Investigator: Mingfeng He, Master
      • Sub-Investigator: Chunxing Duan, Master
      • Sub-Investigator: Shanshan Ling, Postgraduate
• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • The Chinese University of Hong Kong
    • Contact: Vincent Chi-Kwan Cheung, Doctor; Phone Number: (852)59270597; Email: vckc@cuhk.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Ⅳ 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Treatment Group A; Abdominal acupuncture and upper limb rehabilitation training	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_COMPARATOR: Treatment Group B; Sham abdominal acupuncture and upper limb rehabilitation training	Other: 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.; Other Names: Upper limb rehabilitation training
NO_INTERVENTION: Control Group; Upper limb rehabilitation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test	See the study protocol for details	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Brunnstrom staging of upper limb movement	See the study protocol for details	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	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Modified Barthel Index，MBI	See the study protocol for details	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Collaborators: Chinese University of Hong Kong
• Investigators: Principal Investigator: Hongxia Chen, Master, Director of the rehabilitation department; Principal Investigator: Vincet Chi-kwan Cheung, Doctor, Assistant Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2019
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 7, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (ACTUAL): October 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 7, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Brain Plasticity; Functional magnetic resonance imaging（fMRI）; Surface electromyography （sEMG）; Abdominal acupuncture; Effects and mechanism
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Brain Ischemia; Ischemia
• Other Study ID Numbers: YN2018HK03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No