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The purpose of this study is to investigate the effect of dual-mode non-invasive brain stimulation (NIBS) with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex compared with rTMS alone in patients with Parkinson's disease (PD) with freezing of gait (FOG).
Patients in the dual-mode group underwent five consecutive daily sessions of dual-mode NIBS with simultaneous high-frequency rTMS and tDCS, whereas patients in the rTMS group underwent high-frequency rTMS with sham tDCS. Assessments of FOG, motor, ambulatory and cognitive function were performed three times: at baseline before NIBS, immediately after NIBS, and one week after cessation of NIBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dual-mode group | Experimental | the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously |
|
| rTMS group | Active Comparator | high-frequency rTMS and sham tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS and tDCS | Device | Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Freezing of Gait Questionnaire (FOG-Q) | Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome. | Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28193533 | Derived | Chang WH, Kim MS, Park E, Cho JW, Youn J, Kim YK, Kim YH. Effect of Dual-Mode and Dual-Site Noninvasive Brain Stimulation on Freezing of Gait in Patients With Parkinson Disease. Arch Phys Med Rehabil. 2017 Jul;98(7):1283-1290. doi: 10.1016/j.apmr.2017.01.011. Epub 2017 Feb 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual-mode Group | the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
| FG001 | rTMS Group | high-frequency rTMS and sham tDCS rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
32 patients with Parkinson's disease
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual-mode Group | the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Freezing of Gait Questionnaire (FOG-Q) | Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome. | Posted | Mean | Standard Deviation | score | Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dual-mode Group | the dual-mode NIBS with high-frequency rTMS and tDCS simultaneously rTMS and tDCS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Won Hyuk Chang | Samsung Medical Center | 82234102818 | wh.chang@samsung.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D004599 | Electric Stimulation Therapy |
| D003295 | Convulsive Therapy |
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|
| rTMS | Device | Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
|
| BG001 | rTMS Group | high-frequency rTMS and sham tDCS rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Right Handedness | Count of Participants | Participants |
|
| OG001 | rTMS Group | high-frequency rTMS and sham tDCS rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | rTMS Group | high-frequency rTMS and sham tDCS rTMS: Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D013000 |
| Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |