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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
| Seoul National University Hospital | OTHER |
| Bucheon St. Mary's Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipsilateral High-Frequency | Experimental | Patients with motor priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over more affected primary motor cortex (M1) of lower extremity will be applied. |
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| Bilateral High-Frequency1 | Active Comparator | Patients with motor priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied. |
|
| DLPFC High-Frequency | Experimental | Patients with cognitive priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over Lt. dorsolateral prefrontal cortex (DLPFC) will be applied. |
|
| Bilateral High-Frequency2 | Active Comparator | Patients with cognitive priority confirmed by TUG and TUG-Cog tests. High-frequency (HF) rTMS over bilateral M1 of lower extremities will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Frequency, ipsilateral M1 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of Timed Up and Go Test (TUG) | Measurement for gait function. | From baseline T0 to Post-intervention T2 (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Differences of Timed Up and Go Test (TUG) | Measurement for gait function. | From baseline T0 to During-intervention T1 (2 weeks) |
| Differences of Timed Up and Go Test (TUG) | Measurement for gait function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Won Hyuk Chang, PhD | Contact | +82-2-3410-6068 | wh.chang@samsung.com | |
| Ho Seok Lee, PhD | Contact | +82-2-3410-2810 | hoseok89.lee@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Won Hyuk Chang, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39152467 | Derived | Yun SJ, Lee HS, Kim DH, Im S, Yoo YJ, Kim NY, Lee J, Kim D, Park HY, Yoon MJ, Kim YS, Chang WH, Seo HG. Efficacy of personalized repetitive transcranial magnetic stimulation based on functional reserve to enhance ambulatory function in patients with Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2024 Aug 16;25(1):543. doi: 10.1186/s13063-024-08385-2. |
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| OTHER |
| Saint Vincent's Hospital, Korea | OTHER |
| Severance Hospital | OTHER |
| Kumoh National Institute of Technology | UNKNOWN |
| NEUROPHET | INDUSTRY |
prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial
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The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis.
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| High-Frequency, bilateral M1 | Device | 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. |
|
| High-Frequency, Lt. DLPFC | Device | 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. |
|
| High-Frequency, bilateral M1 | Device | 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. |
|
| 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. | 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. | 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. | 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 | 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 | 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 | 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 | From baseline T0 to Follow-up T3 (2 months) |
| Differences of Digit span Test | Measurement for cognitive function | From baseline T0 to Post-intervention T2 (4 weeks) |
| Differences of Digit span Test | Measurement for cognitive function | From baseline T0 to Follow-up T3 (2 months) |
| Differences of Trail making Test | Measurement for cognitive function | From baseline T0 to Post-intervention T2 (4 weeks) |
| Differences of Trail making Test | Measurement for cognitive function | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From baseline T0 to Follow-up T3 (2 months) |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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