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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117465
• Other study ID #: SZSixth_001
• Status: Completed
• Phase: N/A
• First received: April 12, 2017
• Last updated: April 17, 2018
• Start date: July 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Shenzhen Sixth People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Sixth People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fugl-Meyer assessment	To evaluates and measure the motor function.	changes of baseline and day 14 after treatment