Scalp Acupuncture Combined rTMS on Brain White Matter Microstructure of Hemiplegic Patients With Stroke

Based on the Method of Tract-based Spatial Statistics Investigated Scalp Acupuncture Combined Low-frequency Repetitive Transcranial Magnetic Stimulation on Brain White Matter Microstructure of Hemiplegic Patients With Stroke

To apply Bold-fMRI technology to observe and compare the differences of task-related activation of relevant brain cortex region in stroke hemiplegic patients and healthy subjects after finger grasping movement.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: the experimental group; Other: the control group

Detailed Description

Stroke is one of the common cerebrovascular diseases. With the improvement of medical conditions and treatment technology, the death rate of stroke patients has declined, but the disability rate has increased. In China about 50%-70% of stroke patients have the residual sequelae such as paralysis, paralalia dysfunction and so on.

Hemiplegic is the most frequent sequelae in post-stroke patients, finger movements recovery has already became the most difficult question in all the movement kinematics and dynamics rehabilitation,which affects the total movement function and ability of daily life in the patients.The finger recovery is tightly related to the neural plastic and brain function realignment.Furthermore, whether the special brain movement functional cortex area in bilateral hemispheres can be effectively activated is the crucial solved link. A number of recent literature have displayed the special brain motor area including the primary motor cortex(M1), the supplementary motor area(SMA), the premotor area(PMA), the primary sensorimotor area(SM1),the secondary area(SM2), the cingulate sulcus area(CMA) and the cerebellum hemispheres(CB). However，the study on the above-mentioned motor area synchronously activated when the patients after systematically rehabilitative treatment performed fingers grasping task was reported rarely.

Bold-fMRI technology is a new brain functional imaging technology developed on the basis of MRI in 1990s, which not only retains the anatomical imaging characteristics of ordinary MRI, but also obtains the physiological information. The emergence of Bold-fMRI technology provides a new way to study the mechanism, evaluation and prognosis of stroke rehabilitation, and it shows a good research and clinical application value in the field of rehabilitation medicine.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• at the same time in accordance with ischemic stroke of Chinese and western medicine diagnostic criteria;
• the first time stroke, unilateral stroke or once attack but not remnant nerve dysfunction;
• stable vital signs and clear consciousness;
• unilateral upper limb Brunnstrom evaluation;
• age from 30 to 60 years;
• the course of disease was within 1 year.

Exclusion Criteria:

• a history of epilepsy;
• the important organs function failed such as heart, lung, liver and kidney;
• serious cognitive impairment and poor compliance;
• wearing a pacemaker、intracranial metal implants, or with skull defects;
• serious cervical spine including cervical stenosis and instability of cervical spine;
• Women during pregnancy;
• patients cannot tolerate fMRI study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the experimental group; Stroke hemiplegia patients are randomly assigned to the experimental group (scalp acupuncture + low frequency repetitive transcranial magnetic stimulation + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.	Other: the experimental group; Stroke hemiplegia patients are randomly assigned to the experimental group (scalp acupuncture + low frequency repetitive transcranial magnetic stimulation + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.
Other: the control group; Stroke hemiplegia patients are randomly assigned to the control group (scalp acupuncture + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.	Other: the control group; Stroke hemiplegia patients are randomly assigned to the control group (scalp acupuncture + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bold-fMRI examination	To observe and compare the differences of task-related activation of relevant brain cortex region in stroke hemiplegic patients and healthy subjects after finger grasping movement.	changes of baseline and day 14 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer assessment	To evaluates and measure the motor function.	changes of baseline and day 14 after treatment

Collaborators and Investigators

• Sponsor: Shenzhen Sixth People's Hospital
• Investigators: Principal Investigator: Ning Zhao, Master, Shenzhen Sixth People's Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SZSixth_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED