rTMS Study to Improve Functional Performance for Patients With Stroke

Completed

Phase 3 Results N/A

Update History

12 Dec '15
The description was updated.
New
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) - Timed Up and Go (TUG) test was used to assess the gross mobility. - Barthel Index (BI) for the ADL independence - modified Rankin Scale (MRS) for disability classification were also collected. 3. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Old
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) - Timed Up and Go (TUG) test was used to assess the gross mobility. - Barthel Index (BI) for the ADL independence - modified Rankin Scale (MRS) for disability classification were also collected. 3. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Trial was updated to "Phase 3."
The eligibility criteria were updated.
New
Inclusion Criteria: - unilateral hemiplegia caused by the stroke, - first ever stroke, - time since stroke: 10-90 days, - age: 18-80 y/o, - Functional ambulation classification (FAC): 0-2, Exclusion Criteria: - contraindication to TMS (eg, pacemaker, seizure history, pregnancy), - cranial metal implants - intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy - able to complete Timed Up and Go (TUG) test within 2 minutes - unable to walk normally before the stroke - those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
Old
Inclusion Criteria: - unilateral hemiplegia caused by the stroke, - first ever stroke, - time since stroke: 10-90 days, - age: 18-80 y/o, - Functional ambulation classification (FAC): 0-2, Exclusion Criteria: - contraindication to TMS (eg, pacemaker, seizure history, pregnancy), - cranial metal implants - intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy - able to complete Timed Up and Go (TUG) test within 2 minutes - unable to walk normally before the stroke - those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
A location was updated in New Taipei City.
New
The overall status was removed for Shuang Ho Hospital.
10 Dec '14
The description was updated.
New
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) - Timed Up and Go (TUG) test was used to assess the gross mobility. - Barthel Index (BI) for the ADL independence - modified Rankin Scale (MRS) for disability classification were also collected. 3. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Old
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) - Timed Up and Go (TUG) test was used to assess the gross mobility. - Barthel Index (BI) for the ADL independence - modified Rankin Scale (MRS) for disability classification were also collected. 3. Corticomotor excitability assessments. e. Timing of measurements: pretest (1 day before the intervention), the and post-test (immediately after the 15-day interventions are completed), and 3 months after the interventions are completed. 4. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
27 Mar '14
The description was updated.
New
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) - Timed Up and Go (TUG) test was used to assess the gross mobility. - Barthel Index (BI) for the ADL independence - modified Rankin Scale (MRS) for disability classification were also collected. 3. Corticomotor excitability assessments. e. Timing of measurements: pretest (1 day before the intervention), the and post-test (immediately after the 15-day interventions are completed), and 3 months after the interventions are completed. 4. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Old
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 1. Time since stroke and severity of motor deficits are important predictors for motor recovery after stroke. To ensure that both experiment (E) and control (C) groups would be balanced regarding these two factors, the participants were stratified into 4 strata by the time since stroke (10-30 and 31-90 days) and manual muscle strength of paretic quadriceps (0-2 and 3-4, based on the pretest assessment). 2. The subjects in each stratum were then randomly allocated by a 1:1 ratio (with a block of 2) into either E or C group. 3. The randomization was performed by a researcher who tossed a coin to assign the treatment. The researcher kept the record of randomization with a code book which was properly placed in a locker. The same researcher would performed the rTMS (either a real one or a sham one) in the interventions. Therefore, No one except him would know the assignment of treatment. 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. The statistical analyzer was not involved in the study protocol. The assignment of study was disclosed after the enrollment and follow-up was completed. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. The primary outcome was the postural control measurement, and the secondary outcomes were the measurements of motor function of lower extremity, independence of ADL, mobility, and corticomotor excitability. These measurements were performed before and after the interventions by the same investigator. 3. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) (score range, 0~34) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) were also used to assess the balance and gait respectively. - Timed Up and Go (TUG) test was used to assess the gross mobility. - Those assessments including Barthel Index (BI) for the ADL independence, and modified Rankin Scale (MRS) for disability classification were also collected. 4. Corticomotor excitability assessments. During examination, subjects sat in a cushioned wheelchair to keep head stabilized and knees flexed at 45 degree. Surface electromyography (EMG) electrodes (Ag-AgCl) were placed on rectus femoris with active recorder placed on the midpoint between anterior superior iliac spine (ASIS) and the patella and reference recorder on the superior border of patella. The active motor threshold (MT), MEP latency (MEP-lat), and MEP amplitude (MEP-amp) of rectus femoris were recorded by the EMG in response to TMS delivered by MagStim rapid2 stimulator (MagStim Co, Ltd, Carmarthenshire, Wales, UK) with a 110-mm double-cone coil (maximum power 1.4 T) over the contralateral M1. These parameters were measured under pre-activation which was standardized in the way that the participant was asked to force the quadriceps to keep the gross motor unit action potentials (MUAPs) on the real-time EMG oscilloscope at a size of 0.2 mV.This degree of pre-activation was chosen because the reading of MEP was less interfered by MUAPs in that case and it was easy to achieve in the paraplegic leg if the MMT was greater than 1. The MT (expressed as %-stimulator power) was determined by moving the coil over the scalp and observing the MEPs sized larger than 50 μV of peak-to-peak amplitude in 5 of 10 responses under the minimal intensity required. The stimulation intensity at 120% of MT determined at pre-test was applied to measure MEP-lat and MEP-amp at pretest and post-test. A total of 10 stimulations were collected and averaged for MEP analysis. The stimulation site where the MT-UH was determined was the hot spot for subsequent rTMS. The location of hot spot was recorded as x, y in centimeters from vertex (cz) and marked on the scalp. 5. Timing of measurements: pretest (1 day before the intervention), the and post-test (immediately after the 15-day interventions are completed), and 3 months after the interventions are completed. 6. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study. 8. Statistics Normality of distribution of continuous variables was tested with the Kolmogorov-Smirnov statistic. Between-group difference was tested by independent t test or Mann-Whitney U test for parametric or non-parametric variables respectively. Within-group difference was tested by Paired t test or Wilcoxon test for parametric or non-parametric variables respectively. Between-group comparison for categorical variables was tested by χ2 analysis. The achievement of optimal improvement of mobility was defined as the capability to finish the TUG test within 2 minutes at posttest. The improvement of disability was defined as improvement of MRS ≧ 1 at posttest. The number of subjects who achieved optimal improvement of mobility and disability was compared between groups by χ2 test.Repeated measures ANOVA was used to for multiple comparisons. A two-tailed P < 0.05 represented the significant level. All analyses were performed using the SPSS 17.0 statistical package.
13 Dec '13
Trial name was updated.
New
rTMS Study to Improve Functional Performance for Patients With Stroke
The Summary of Purpose was updated.
New
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
Old
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. We conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. We hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
The description was updated.
New
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 1. Time since stroke and severity of motor deficits are important predictors for motor recovery after stroke. To ensure that both experiment (E) and control (C) groups would be balanced regarding these two factors, the participants were stratified into 4 strata by the time since stroke (10-30 and 31-90 days) and manual muscle strength of paretic quadriceps (0-2 and 3-4, based on the pretest assessment). 2. The subjects in each stratum were then randomly allocated by a 1:1 ratio (with a block of 2) into either E or C group. 3. The randomization was performed by a researcher who tossed a coin to assign the treatment. The researcher kept the record of randomization with a code book which was properly placed in a locker. The same researcher would performed the rTMS (either a real one or a sham one) in the interventions. Therefore, No one except him would know the assignment of treatment. 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. The statistical analyzer was not involved in the study protocol. The assignment of study was disclosed after the enrollment and follow-up was completed. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. The primary outcome was the postural control measurement, and the secondary outcomes were the measurements of motor function of lower extremity, independence of ADL, mobility, and corticomotor excitability. These measurements were performed before and after the interventions by the same investigator. 3. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) (score range, 0~34) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) were also used to assess the balance and gait respectively. - Timed Up and Go (TUG) test was used to assess the gross mobility. - Those assessments including Barthel Index (BI) for the ADL independence, and modified Rankin Scale (MRS) for disability classification were also collected. 4. Corticomotor excitability assessments. During examination, subjects sat in a cushioned wheelchair to keep head stabilized and knees flexed at 45 degree. Surface electromyography (EMG) electrodes (Ag-AgCl) were placed on rectus femoris with active recorder placed on the midpoint between anterior superior iliac spine (ASIS) and the patella and reference recorder on the superior border of patella. The active motor threshold (MT), MEP latency (MEP-lat), and MEP amplitude (MEP-amp) of rectus femoris were recorded by the EMG in response to TMS delivered by MagStim rapid2 stimulator (MagStim Co, Ltd, Carmarthenshire, Wales, UK) with a 110-mm double-cone coil (maximum power 1.4 T) over the contralateral M1. These parameters were measured under pre-activation which was standardized in the way that the participant was asked to force the quadriceps to keep the gross motor unit action potentials (MUAPs) on the real-time EMG oscilloscope at a size of 0.2 mV.This degree of pre-activation was chosen because the reading of MEP was less interfered by MUAPs in that case and it was easy to achieve in the paraplegic leg if the MMT was greater than 1. The MT (expressed as %-stimulator power) was determined by moving the coil over the scalp and observing the MEPs sized larger than 50 μV of peak-to-peak amplitude in 5 of 10 responses under the minimal intensity required. The stimulation intensity at 120% of MT determined at pre-test was applied to measure MEP-lat and MEP-amp at pretest and post-test. A total of 10 stimulations were collected and averaged for MEP analysis. The stimulation site where the MT-UH was determined was the hot spot for subsequent rTMS. The location of hot spot was recorded as x, y in centimeters from vertex (cz) and marked on the scalp. 5. Timing of measurements: pretest (1 day before the intervention), the and post-test (immediately after the 15-day interventions are completed), and 3 months after the interventions are completed. 6. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study. 8. Statistics Normality of distribution of continuous variables was tested with the Kolmogorov-Smirnov statistic. Between-group difference was tested by independent t test or Mann-Whitney U test for parametric or non-parametric variables respectively. Within-group difference was tested by Paired t test or Wilcoxon test for parametric or non-parametric variables respectively. Between-group comparison for categorical variables was tested by χ2 analysis. The achievement of optimal improvement of mobility was defined as the capability to finish the TUG test within 2 minutes at posttest. The improvement of disability was defined as improvement of MRS ≧ 1 at posttest. The number of subjects who achieved optimal improvement of mobility and disability was compared between groups by χ2 test.Repeated measures ANOVA was used to for multiple comparisons. A two-tailed P < 0.05 represented the significant level. All analyses were performed using the SPSS 17.0 statistical package.
Old
Protocol: 1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital. 2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). 3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. 4. Study design: controlled trial with stratified randomization 1. Time since stroke and severity of motor deficits are important predictors for motor recovery after stroke. To ensure that both experiment (E) and control (C) groups would be balanced regarding these two factors, the participants were stratified into 4 strata by the time since stroke (10-30 and 31-90 days) and manual muscle strength of paretic quadriceps (0-2 and 3-4, based on the pretest assessment). 2. The subjects in each stratum were then randomly allocated by a 1:1 ratio (with a block of 2) into either E or C group. 3. The randomization was performed by a researcher who tossed a coin to assign the treatment. The researcher kept the record of randomization with a code book which was properly placed in a locker. The same researcher would performed the rTMS (either a real one or a sham one) in the interventions. Therefore, No one except him would know the assignment of treatment. 5. Blinding 1. The patients were blinded by the real or sham coil of rTMS 2. The assessors who performed the outcome measurements were blinded to the assignment of treatment. The statistical analyser was not involed in the study protocol. The assignment of study was disclosed after the enrollment and follow-up was completed. 6. Measurements. 1. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. 2. The primary outcome was the postural control measurement, and the secondary outcomes were the measurements of motor function of lower extremity, independence of ADL, mobility, and corticomotor excitability. These measurements were performed before and after the interventions by the same investigator. 3. Clinical assessments. - Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. - The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) (score range, 0~34) - The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) were also used to assess the balance and gait respectively. - Timed Up and Go (TUG) test was used to assess the gross mobility. - Those assessments including Barthel Index (BI) for the ADL independence, and modified Rankin Scale (MRS) for disability classification were also collected. 4. Corticomotor excitability assessments. During examination, subjects sat in a cushioned wheelchair to keep head stabilized and knees flexed at 45 degree. Surface electromyography (EMG) electrodes (Ag-AgCl) were placed on rectus femoris with active recorder placed on the midpoint between anterior superior iliac spine (ASIS) and the patella and reference recorder on the superior border of patella. The active motor threshold (MT), MEP latency (MEP-lat), and MEP amplitude (MEP-amp) of rectus femoris were recorded by the EMG in response to TMS delivered by MagStim rapid2 stimulator (MagStim Co, Ltd, Carmarthenshire, Wales, UK) with a 110-mm double-cone coil (maximum power 1.4 T) over the contralateral M1. These parameters were measured under pre-activation which was standardized in the way that the participant was asked to force the quadriceps to keep the gross motor unit action potentials (MUAPs) on the real-time EMG oscilloscope at a size of 0.2 mV.This degree of pre-activation was chosen because the reading of MEP was less interfered by MUAPs in that case and it was easy to achieve in the paraplegic leg if the MMT was greater than 1. The MT (expressed as %-stimulator power) was determined by moving the coil over the scalp and observing the MEPs sized larger than 50 μV of peak-to-peak amplitude in 5 of 10 responses under the minimal intensity required. The stimulation intensity at 120% of MT determined at pre-test was applied to measure MEP-lat and MEP-amp at pretest and posttest. A total of 10 stimulations were collected and averaged for MEP analysis. The stimulation site where the MT-UH was determined was the hot spot for subsequent rTMS. The location of hot spot was recorded as x, y in centimeters from vertex (cz) and marked on the scalp. 5. Timing of measurements: pretest (1 day before the intervention), the and posttest (immediately after the 15-day interventions are completed), and 3 months after the interventions are completed. 6. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. 7. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study. 8. Statistics Normality of distribution of continuous variables was tested with the Kolmogorov-Smirnov statistic. Between-group difference was tested by independent t test or Mann-Whitney U test for parametric or non-parametric variables respectively. Within-group difference was tested by Paired t test or Wilcoxon test for parametric or non-parametric variables respectively. Between-group comparison for categorical variables was tested by χ2 analysis. The achievement of optimal improvement of mobility was defined as the capability to finish the TUG test within 2 minutes at posttest. The improvement of disability was defined as improvement of MRS ≧ 1 at posttest. The number of subjects who achieved optimal improvement of mobility and disability was compared between groups by χ2 test.Repeated measures ANOVA was used to for multiple comparisons. A two-tailed P < 0.05 represented the significant level. All analyses were performed using the SPSS 17.0 statistical package.