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The Effects of Combined Low Frequency Repetitive Transcranial Magnetic Stimulation and Motor Imagery on Upper Extremity Motor Recovery Following Stroke

Status Approved

  • First Submitted Date

    2024/03/05

  • Registered Date

    2024/05/03

  • Last Updated Date

    2024/04/09

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0009391
    Unique Protocol ID 2-1041055-AB-N-01-2024-03
    Public/Brief Title The Effects of Combined Low Frequency Repetitive Transcranial Magnetic Stimulation and Motor Imagery on Upper Extremity Motor Recovery Following Stroke
    Scientific Title The Effects of Combined Low Frequency Repetitive Transcranial Magnetic Stimulation and Motor Imagery on Upper Extremity Motor Recovery Following Stroke
    Acronym LF-rTMS, MIT
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2-1041055-AB-N-01-2024-03
    Approval Date 2024-02-13
    Institutional Review Board Name Institutional Review Board of Chosun University
    Institutional Review Board Address 309, Pilmun-daero, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-230-6692
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jong-Bae Choi
    Title assistant professor
    Telephone +82-62-230-7097
    Affiliation Chosun University
    Address Chosun University, 146 Chosundae-gil, Dong-gu (Seoseok-dong)
    Contact Person for Public Queries
    Name Jong-Bae Choi
    Title assistant professor
    Telephone +82-62-230-7097
    Affiliation Chosun University
    Address Chosun University, 146 Chosundae-gil, Dong-gu (Seoseok-dong)
    Contact Person for Updating Information
    Name Jong-Bae Choi
    Title assistant professor
    Telephone +82-62-230-7097
    Affiliation Chosun University
    Address Chosun University, 146 Chosundae-gil, Dong-gu (Seoseok-dong)
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2024-05-01 Anticipated
    Target Number of Participant 30
    Primary Completion Date 2025-02-21 , Anticipated
    Study Completion Date 2025-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Bobath Memorial Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2024-05-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Chosun University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chosun University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    More than 85% of stroke patients experience hemiplegia, and more than 70% of them have impairment of upper limb function. It affects human relationships and increases economic burden. Accordingly, various treatment interventions are being studied for the recovery of upper limb function in various stroke patients. Recently, a parallel approach with a combination of various techniques was reported to be better for improving upper limb function compared to a single intervention. Among various treatment techniques to restore upper limb function in stroke patients, repetitive transcranial magnetic stimulation (rTMS), which has recently been studied extensively, is mainly used. rTMS activates M1 on the damaged side through stimulation of the cerebral cortex on the uninjured side and can help motor recovery of the upper extremity. Additionally, research on motor imagery (MI) is being conducted, and motor cortex activation equivalent to actual active movement was reported through MI in severe stroke patients with limited movement. MI is defined as a cognitive practice process of imagining body movements in one's mind through executive memory without actual body movements. Brain imaging studies show that during imagination training, activation occurs in the same area of the cerebral cortex, similar to when engaging in actual physical activity, and the corticospinal tract is also activated, which is related to cortical plasticity. It was reported that it was the effect of plasticity. However, currently, little research has been conducted combining the two intervention methods, and the purpose of this study is to investigate the effect of low-frequency rTMS combined with MI training on the recovery of upper limb function in patients with hemiplegia after stroke.
    ​
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device, Behavioral  
    Intervention Description
    Participants are recruited through recruitment notices at research institutions, and the Mini-Cognitive Evaluation (MMSE-K) and Fugl-Meyer assessment are conducted as screening tests, and those who meet the selection criteria are invited to participate in the study through voluntary consent. All participants were randomly divided into an experimental group and a control group, and pre-tested the Fugl-Meyer Assessment, Wolf-Motor Function Test, and Action Research Arm test  to evaluate upper limb function. Additionally, motor evoked potential (MEP) is evaluated to evaluate cerebral cortex activation. Afterwards, the experimental group will receive 20 minutes of low-frequency repetitive transcranial magnetic stimulation combined with motor imagery training, and the control group will receive only low-frequency repetitive transcranial magnetic stimulation for 20 minutes, once a day, 3 days a week, for 12 weeks, and a post-evaluation will be conducted.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    In this study, the ALTMS ®device, which consists of a 70mm 8-shaped coil, was used to apply LF-rTMS to the subjects.  In this study, First Dorsal Interosseous (FDI) is identified as the target muscle.
    The resting motor threshold (RMT) is set as the minimum stimulation intensity at which MEPs of 50 μV or more are recorded in at least 5 out of 10 stimulations. A frequency of 1 Hz is applied to activate the cerebral cortex on the damaged side with an intensity of MT 90% at 900 pulses. In this study, subjects in the experimental group performed 20 minutes a day, 3 times a week, for 8 weeks, for a total of 24 times. And the experimental group performed motor imagery at the same time. The contents of motor imagery are as follows.
    Motor imagery was conducted in a quiet, independent space with research subjects selecting 10 intimate, purposeful, and meaningful tasks that had significantly improved upper limb function in previous studies. Subjects in the experimental group performed motor imagery of 10 tasks simultaneously with low-frequency repetitive transcranial magnetic stimulation. The 10 tasks were selected as tasks frequently performed in daily life, such as cooking, using a cell phone, eating, getting dressed, washing one's face, brushing teeth, using the computer, combing hair, writing, and drinking water. Before starting imagination training, subjects practice imagining each task with the help of a therapist and have an imagination training rehearsal process in which they picture detailed situations in their heads according to the therapist's advice.
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    15

    Arm Type

    Active comparator

    Arm Description

    n this study, the ALTMS ®device, which consists of a 70mm 8-shaped coil, was used to apply LF-rTMS to the subjects.  In this study, First Dorsal Interosseous (FDI) is identified as the target muscle.
    The resting motor threshold (RMT) is set as the minimum stimulation intensity at which MEPs of 50 μV or more are recorded in at least 5 out of 10 stimulations. A frequency of 1 Hz is applied to activate the cerebral cortex on the damaged side with an intensity of MT 90% at 900 pulses. In this study, subjects in the experimental group performed 20 minutes a day, 3 times a week, for 8 weeks, for a total of 24 times.  The control group does not undergo motor imagery training.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I64)Stroke, not specified as haemorrhage or infarction 

    Patients with stroke hemiplegia due to cerebrovascular disease
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~80Year

    Description

    Patients diagnosed with stroke and hemiplegia by a rehabilitation medicine doctor; those with subacute hemiparesis < 6 months after stroke onset; those with an MMSE-K score of ≥ 24 who can understand and execute the instructions; those with a grade ≤ 3 (F) in the manual muscle test of the wrist extensor muscles; and those with severe up-per extremity function impairment with an FMA UE score of ≤ 19, were included. 
    Exclusion Criteria
    The following are the exclusion criteria: case when an artificial pacemaker is attached; those with severe pain in the upper extremity on the paralyzed side (VAS score of ≥ 5; those who have metal in their skull; and those who have had a pacemaker, intracardi-ac wire, or metal implanted.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    To evaluate the improvement of upper limb function, Fugl–Meyer assessment upper extremity (FMA UE), wolf motor function test (WMFT), and action research arm test (ARAT) were used. To evaluate M1 activation, motor-evoked potential (MEP) ampli-tude was measured using TMS
    Timepoint
    It is conducted twice, before and after the 8-week intervention.
    Secondary Outcome(s) 1
    Outcome
    To evaluate primary motor cortex activation, motor-evoked potential (MEP) amplitude was measured using trandcranial magnetic stimulation.
    Timepoint
    It is conducted twice, before and after the 8-week intervention.
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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