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
CRIS Registration Number |
KCT0009391 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Chosun University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chosun University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
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 |
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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)
Type of Primary Outcome | Efficacy | |
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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. |
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Secondary Outcome(s) 1 | ||
Outcome | To evaluate primary motor cortex activation, motor-evoked potential (MEP) amplitude was measured using trandcranial magnetic stimulation. |
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Timepoint | It is conducted twice, before and after the 8-week intervention. |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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