To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
Patients aged 19 to 80 years old
Those who are confirmed to have lesions in only one cerebral hemisphere or one brainstem on brain computed tomography (CT) or brain magnetic resonance imaging (MRI)
Patients with subacute stroke between 2 weeks and less than 3 months after onset
Motor function evaluation The total score is 0 to 56 points based on the FMA of the upper extremity on the affected side [1], and patients show impairment in upper extremity motor function.
Cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease
Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke.
Those with unstable conditions in the cardiovascular, digestive, respiratory, and endocrine systems, or with severe internal diseases such as signs of systemic infection, with unstable vital signs, or with poor overall health with a life expectancy of less than 1 year.
Those with impaired cognitive ability (MMSE less than 10 points)
Single group
wearable rTMS
DeviceApplication of inhibitory low-frequency rTMS on unaffected primary motor cortex by wearable rTMS
Safety
All types of adverse events that occurred during clinical trials
Changes of Fugl-Meyer assessment
Fugl-Meyer assessment for motor function in score
Changes of manual muscle test (MMT)
Manual muscle test for strength in score
Changes of box and block test (BBT)
Box and block test for gross manual dexterity in number of blocks from on compartment of a box to another of equal size within 60 seconds
Changes of action research arm test (ARAT)
Action research arm test for functional ability of upper extremity in score
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