Samsung Medical Center
Seoul, 06351, South Korea
Location status: Recruiting
NCT Number: NCT06350617
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Seoul, 06351, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function.
Time frame: From baseline T0 to During-intervention T1 (2 weeks)
Measurement for gait function.
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait function.
Time frame: From baseline T0 to During-intervention T1 (2 weeks)
Measurement for gait and cognitive function.
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait and cognitive function.
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait and cognitive function.
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
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)
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)
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)
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)
Measurement for cognitive function
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for cognitive function
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for cognitive function
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for cognitive function
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function. Gait speed (km/hr) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait function. unit: km/hr Gait speed (km/hr) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function Stride length (m) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait function Stride length (m) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function Step count will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait function Step count will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
Measurement for gait function Cadence (step count/min) will be measured
Time frame: From baseline T0 to Follow-up T3 (2 months)
Measurement for gait function Cadence (step count/min) will be measured
Time frame: From baseline T0 to Post-intervention T2 (4 weeks)
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)
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)
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)
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)
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)
Measurement for gait function Pressure distribution (unit - pecentage, pressure distribution among heel, mild, and toe) will be measured
Contact information is provided by the study sponsor or research team.
Ho Seok Lee, PhD
CONTACT
Won Hyuk Chang, PhD
CONTACT
Samsung Medical Center
Other
Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease
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