Clinical trial NCT03117465: Scalp Acupuncture Combined rTMS on Brain White Matter Microstructure of Hemiplegic Patients With Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Shenzhen Sixth People's Hospital
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All the hemiplegic patients were mainly derived from stroke recovery periodical inpatients from September 2015 to September 2016 in rehabilitation unit of shenzhen nanshan district people's hospital, Guangdong Province,China. All subjects were told in detail about the risks and signed informed consent before the experiment.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bold-fMRI examination
timeFrame: changes of baseline and day 14 after treatment
Secondary outcomes:
measure: Fugl-Meyer assessment
timeFrame: changes of baseline and day 14 after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen Sixth People's Hospital
name: Ning Zhao, Master
role: PRINCIPAL_INVESTIGATOR
References: