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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03117465
First Posted: April 18, 2017
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ning Zhao, Shenzhen Sixth People's Hospital
  Purpose
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.

Condition Intervention
Stroke Other: the experimental group Other: the control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ning Zhao, Shenzhen Sixth People's Hospital:

Primary Outcome Measures:
  • Bold-fMRI examination [ Time Frame: changes of baseline and day 14 after treatment ]
    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.


Secondary Outcome Measures:
  • Fugl-Meyer assessment [ Time Frame: changes of baseline and day 14 after treatment ]
    To evaluates and measure the motor function.


Estimated Enrollment: 28
Study Start Date: July 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117465


Sponsors and Collaborators
Shenzhen Sixth People's Hospital
Investigators
Principal Investigator: Ning Zhao, Master Shenzhen Sixth People's Hospital
  More Information

Responsible Party: Ning Zhao, Attending Physician, Shenzhen Sixth People's Hospital
ClinicalTrials.gov Identifier: NCT03117465     History of Changes
Other Study ID Numbers: SZSixth_001
First Submitted: April 12, 2017
First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases