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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
the experimental group
the control group
Sponsored by
Shenzhen Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    the experimental group

    the control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Fugl-Meyer assessment
    To evaluates and measure the motor function.

    Full Information

    First Posted
    April 12, 2017
    Last Updated
    April 17, 2018
    Sponsor
    Shenzhen Sixth People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03117465
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    April 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shenzhen Sixth People's Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the experimental group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    the control group
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    the experimental group
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    the control group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Bold-fMRI examination
    Description
    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.
    Time Frame
    changes of baseline and day 14 after treatment
    Secondary Outcome Measure Information:
    Title
    Fugl-Meyer assessment
    Description
    To evaluates and measure the motor function.
    Time Frame
    changes of baseline and day 14 after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ning Zhao, Master
    Organizational Affiliation
    Shenzhen Sixth People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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