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 patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease 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 patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves.
rTMS treatment for patients with Parkinson's disease is traditionally based on stimulating the neural network of brain. The widely-used traditional rTMS treatment protocol involves high-frequency stimulation over the bilateral primary motor cortex (M1) to enhance motor and gait functions. However, concerns have arisen regarding the effect of rTMS on motor recovery in patients with Parkinson's disease. Although still subject to debate, a possible reason for the diverse results of rTMS applied is the uniform application protocol to individuals with varying pathologies and functional reserves, aimed at enhancing recovery. Therefore, this study was aimed to determine the effects of protocols of rTMS therapy based on the functional reserve of each patient with Parkinson's disease. Based on screening evaluations (Timed Up and Go Test (TUG), Timed Up and Go Dual Task-Cognitive (TUG-Cog)), investigators hypothesized that patients could be categorized into two groups: 1) priority in motor functional reserve, 2) priority in cognitive functional reserve. For each group, investigators plan to randomly assign patients to experimental and control groups to demonstrate the efficacy of different rTMS protocols based on functional reserves compared to conventional high-frequency rTMS applied to the bilateral M1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
rTMS 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 of lower extremity. Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
rTMS 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: bilateral primary motor cortex of lower extremity. Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
rTMS 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: Lt. DLPFC Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
rTMS 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: bilateral primary motor cortex of lower extremity. Total rTMS sessions: once a day, 5 days per 2 weeks, for 4 weeks, totaling 10 sessions. Additional treatment: Treadmill gait training after the intervention, as well as the routine pharmacotherapy based on the guidelines for management of patients with Parkinson's disease.
Samsung Medical Center
Seoul, South Korea
RECRUITINGDifferences of Timed Up and Go Test (TUG)
Measurement for gait function.
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Timed Up and Go Test (TUG)
Measurement for gait function.
Time frame: From baseline T0 to During-intervention T1 (2 weeks)
Differences of Timed Up and Go Test (TUG)
Measurement for gait function.
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
Measurement for gait and cognitive function.
Time frame: From baseline T0 to During-intervention T1 (2 weeks)
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
Measurement for gait and cognitive function.
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Timed Up and Go Test-Cognitive (TUG-Cog)
Measurement for gait and cognitive function.
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III
Measurement for motor function of patients with Parkinson's disease. Score ranges from 0 to 132; higher score indicates more severity of disease status
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of MDS-UPDRS, Part III
Measurement for motor function of patients with Parkinson's disease. Score ranges from 0 to 132; higher score indicates more severity of disease status
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of New Freezing of Gait Questionnaire (FoG-Q)
Measurement for gait function of patients with Parkinson's disease Score ranges from 0 to 28; higher score indicates more severity of disease status
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of New Freezing of Gait Questionnaire (FoG-Q)
Measurement for gait function of patients with Parkinson's disease Score ranges from 0 to 28; higher score indicates more severity of disease status
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Digit span Test
Measurement for cognitive function
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Digit span Test
Measurement for cognitive function
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Trail making Test
Measurement for cognitive function
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Trail making Test
Measurement for cognitive function
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Gait speed)
Measurement for gait function. Gait speed (km/hr) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Gait speed)
Measurement for gait function. unit: km/hr Gait speed (km/hr) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Stride length)
Measurement for gait function Stride length (m) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Stride length)
Measurement for gait function Stride length (m) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Step count)
Measurement for gait function Step count will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Step count)
Measurement for gait function Step count will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Cadence)
Measurement for gait function Cadence (step count/min) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Cadence)
Measurement for gait function Cadence (step count/min) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Swing ratio)
Measurement for gait function Swing ratio (% of swing phase of 1 gait cycle) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Swing ratio)
Measurement for gait function Swing ratio (% of swing phase of 1 gait cycle) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Stride time)
Measurement for gait function Stride time (unit- second, time from heel strike to next heel strike) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Stride time)
Measurement for gait function Stride time (unit- second, time from heel strike to next heel strike) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Differences of Gait lab parameter (Pressure distribution)
Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Differences of Gait lab parameter (Pressure distribution)
Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
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