The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each hemiplegic stroke patient in subacute phase, compared to conventional low-frequency rTMS therapy on contralateral M1. Investigators hypothesized that the functional reserve of each hemiplegic stroke patient will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to stroke patients regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
hemiplegic stroke patients in the subacute phase (7 days to 3 months from the onset) who are currently hospitalized,
FMA score of the upper extremity ≤42,
adequate language and cognitive function to perform at least a 1-step obey-command,
pre-stroke functional level of modified Rankin Scale (mRS) ≤1,
those with contraindications to rTMS, such as epilepsy, implanted metal objects in the head, or a history of craniotomy,
those with progressive of hemodynamically unstable medical conditions,
those with coexisting neurological conditions, such as spinal cord injury or Parkinson's disease,
those with major psychiatric disorders, such as major depression, schizophrenia, or dementia,
Parallel
High-Frequency1
DevicerTMS intervention: 20 sessions of 10-Hz rTMS at 90% resting motor threshold (RMT), 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
cTBS1
DevicerTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
High-Frequency2
DevicerTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: ipsilateral premotor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
cTBS2
DevicerTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
High-Frequency3
DevicerTMS intervention: 20 sessions of 10-Hz rTMS at 90% RMT, 50 pulses per session with a 25-second interval between sessions, totaling 1,000 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
cTBS3
DevicerTMS intervention: 40 seconds of cTBS at 70% RMT, totaling 600 pulses. rTMS target: contralateral primary motor cortex. Total rTMS sessions: once a day, 5 days per week, for 2 weeks, totaling 10 sessions. Additional treatment: inpatient conventional rehabilitation therapy, consisting of occupational and physical therapy for 30 minutes each, twice daily, for 2 weeks, as well as the routine pharmacotherapy based on the guidelines for management of patients with stroke.
6
Treatment groupsSee each treatment group below.
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Differences of Fugl-Meyer Assessment score of Upper Extremity (FMA-UL)
Measurement for motor function of upper limb. Minimum: 0, Maximum: 66. Higher score means a better
Differences of Fugl-Meyer Assessment score (FMA)
Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better
Differences of Fugl-Meyer Assessment score (FMA)
Measurement for motor function of all limbs. Minimum:0, Maximum: 100. Higher score means a better
Click on the lead sponsor to view all of their trials.
Samsung Medical Center
Lead sponsor
National Research Foundation of Korea
Collaborator
Ministry of Food and Drug Safety, Korea
Collaborator
Seoul National University Hospital
Collaborator
Bucheon St. Mary's Hospital
Collaborator
Saint Vincent's Hospital, Korea
Collaborator
Severance Hospital
Collaborator
Kumoh National Institute of Technology
Collaborator
NEUROPHET
Collaborator
