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| Name | Class |
|---|---|
| Korea Brain Research Institute | UNKNOWN |
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The purpose of this study is to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving depressive symptoms in patients with Parkinson's Disease (PD).
Participants will be randomly assigned to either an active rTMS group or a sham-control group.
The study aims to establish an optimal treatment protocol using a neuronavigation system and to validate treatment responses through various digital biomarkers such as facial expression analysis and eye-tracking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real rTMS | Experimental | Participants receive active repetitive transcranial magnetic stimulation (rTMS) to bilateral primary motor cortex (M1), guided by neuronavigation (BrainEyes). Stimulation is delivered at 10 Hz, 90% of resting motor threshold (RMT), 1,000 pulses per session, once daily for 5 consecutive weekdays. Participants continue their existing Parkinson's disease medication throughout the study. |
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| Sham rTMS | Sham Comparator | Participants receive sham repetitive transcranial magnetic stimulation (rTMS) to bilateral primary motor cortex (M1), guided by neuronavigation (BrainEyes). The coil is tilted 90 degrees perpendicular to the scalp so that no magnetic field is delivered to the cortex. The same click sound and scalp sensation are maintained to preserve participant blinding. The session parameters are identical to the active rTMS group (10 Hz, 1,000 pulses per session, once daily for 5 consecutive weekdays). Participants continue their existing Parkinson's disease medication throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | High-frequency rTMS is delivered to bilateral primary motor cortex (M1) using neuronavigation guidance (BrainEyes). Parameters: 10 Hz, 90% of resting motor threshold (RMT), 50 pulses per train, 55-second inter-train interval, 20 trains per session, 1,000 pulses per session, once daily for 5 consecutive weekdays. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | Self-reported measure of depressive symptom severity consisting of 21 items rated on a 4-point Likert scale. Higher scores indicate greater depression severity. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Neuropsychiatric Inventory (NPI) | Caregiver-rated assessment of neuropsychiatric symptoms in Parkinson's disease patients, covering 12 domains including mood, apathy, anxiety, and psychosis. Each domain rated by frequency (1-4) and severity (1-3). | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Disease Questionnaire-39 (PDQ-39) | Disease-specific questionnaire assessing quality of life in Parkinson's disease patients across 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Scores range from 0 to 100; higher scores indicate worse quality of life. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howon Lee, MD | Kyungpook National University Chilgok Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | Buk-gu | 41404 | South Korea |
Individual participant data will not be publicly shared to protect the privacy of the participants. However, de-identified data may be available from the principal investigator upon reasonable request for research purposes, subject to institutional review board approval.
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Participants are randomly assigned to either real rTMS or sham rTMS group. Both groups continue their existing Parkinson's disease medication throughout the study.
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| Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS) | Device | Sham rTMS is delivered with the coil tilted 90 degrees perpendicular to the scalp to prevent magnetic field delivery to the cortex. The same click sound and scalp sensation are maintained. Session parameters are identical to active rTMS group. |
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| Unified Parkinson's Disease Rating Scale (UPDRS) | Comprehensive clinician-administered scale assessing motor and non-motor symptoms of Parkinson's disease across 6 subscales: non-motor experiences of daily living, motor experiences of daily living, motor examination, motor complications, Hoehn and Yahr staging, and Schwab and England ADL scale. Higher scores indicate greater disease severity. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Parkinson's Disease Sleep Scale (PDSS) | Self-reported scale assessing sleep disturbances in Parkinson's disease patients, consisting of 15 items rated on a 5-point Likert scale (0-4). Covers three domains: nocturnal motor symptoms, PD-specific nocturnal symptoms, and sleep-specific disturbances. Higher scores indicate more frequent sleep disturbances. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Toronto Alexithymia Scale-20 Korean Version (TAS20-K) | Korean validated version of the Toronto Alexithymia Scale consisting of 20 items rated on a 5-point Likert scale, assessing three factors: difficulty identifying feelings (DIF), difficulty describing feelings (DDF), and externally oriented thinking (EOT). Higher total scores indicate greater alexithymia. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Montreal Cognitive Assessment (MoCA) | Brief cognitive screening tool assessing multiple cognitive domains including attention, concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Scores range from 0 to 30; higher scores indicate better cognitive function. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Facial Expression Analysis (FaceReader) | Automated facial expression analysis using FaceReader software to quantitatively assess facial action units (AUs) and emotional expression patterns. Participants perform facial emotion recognition and imitation tasks. Measures include response speed, latency, accuracy, and facial expression accuracy based on Action Unit analysis. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Eye Movement Assessment (Eye-tracking) | Quantitative assessment of eye movements using screen-based Tobii Pro Spark. Measures include gaze speed, gaze position, gaze duration, gaze latency, and pupil size during task performance, providing objective evaluation of oculomotor function. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Electromyography (EMG) | Muscle activity is measured using DELSYS Trigno Avanti Sensor and Trigno Quattro Sensor attached to the skin with medical tape. Wireless measurement technology enables free movement during task performance, with real-time data collection via dedicated software. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Static Balance Assessment (BT4) | Quantitative assessment of postural stability using BT4 balance evaluation system, measuring center of pressure (COP) displacement during standing. Assesses limits of stability in anterior, posterior, and lateral directions, and COP movement during Romberg test under eyes-open and eyes-closed conditions. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Body Composition Analysis (InBody) | Basic physical information is collected using InBody580 with 4-pole 8-point tactile electrode method. Bioelectrical impedance is measured across 3 frequency bands (5kHz, 50kHz, 250kHz) in 5 body segments (right arm, left arm, trunk, right leg, left leg), yielding 15 impedance measurements. | Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up) |
| Brain Structural and Functional MRI | Neuroimaging assessment of brain structure and function using MRI with three sequences: T1-weighted and T2-weighted structural imaging, and Diffusion Tensor Imaging (DTI) to assess white matter integrity and structural connectivity. Used to evaluate changes in brain structure before and after rTMS treatment, and to guide neuronavigation-based TMS targeting. | Change from Baseline (T0) at 1 week (T1) after stimulation |
| Blood-based biomarkers | Quantitative measurement of candidate plasma biomarkers including Amyloid beta 40/42, Tau, phosphorylated Tau (p-Tau), and Neurofilament light chain (NfL) using antibody-based quantitative analysis methods (SIMOA, Luminex, or ELISA). | Change from Baseline (T0) at 1 week (T1) after stimulation |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| D009410 | Nerve Degeneration |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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