The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke
After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement. Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations. The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, South Korea
Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
Daejeon, South Korea
Box and Block test
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days
Box and Block test
Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS
Time frame: upto 14 days
Fugl-Meyer Assessment Scale
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days
modified Barthel Index (the Korean version)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days
National Institutes of Health Stroke Scale
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days
Finger tapping
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days
Brunnstrom stage (hand and arm)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
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Time frame: upto 42 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Time frame: upto 42 days