Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
2026年8月3日 更新者：Ho-Won Lee
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease : A Single-Center, Randomized, Single-Blinded, Sham-Controlled, Parallel-Design, Investigator-Initiated Exploratory Clinical Trial
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.
研究概览
地位
邀请报名
研究类型
介入性
注册 (估计的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Buk-gu
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Daegu、Buk-gu、韩国、41404
- Kyungpook National University Chilgok Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Willing and able to provide written informed consent
- Male or female aged 40 to 90 years
- Diagnosed with Parkinson's disease with depressive symptoms
- Hoehn and Yahr stage 1 to 3
- On stable Parkinson's disease medication for at least 3 months prior to screening, with no planned dose increase during the study period
- BDI-II score ≥ 14 (mild depression) or ≥ 20 (moderate depression)
- Able to read and write Korean and capable of independently completing questionnaires
Exclusion Criteria:
- History of epilepsy
- Parkinson's disease caused by cerebrovascular disease, CNS infection, intoxication, or traumatic brain injury
- Diagnosed with Parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, dementia with Lewy bodies etc.)
- Clinically significant abnormal laboratory values (AST, ALT, or total bilirubin > 2.5 x ULN)
- Diagnosed with psychiatric disorders
- Unable to follow instructions or communicate
- Pregnant, breastfeeding, or women of childbearing potential
- Febrile patients
- Patients with artificial hip joint implants
- Presence of conductive, ferromagnetic, or magnetically sensitive metal near the head or treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils)
- Cardiac disease, especially patients with pacemakers
- Corrected or uncorrected visual acuity less than 0.5
- Use of drug infusion pumps or hearing aids
- Patients with acute illness
- Patients taking tricyclic antidepressants, neuroleptics, or other medications that may lower seizure threshold
- History of increased intracranial pressure or head trauma
- Evidence of external wounds on brain or neck
- Prominent psychotic symptoms other than depression (high NPI scores for hallucinations, delusions, mania)
- History of schizophrenia, bipolar disorder, or substance abuse
- Suicidal ideation (BDI-II item 9 score of 2 or 3)
- History of or planned deep brain stimulation or stereotactic surgery (pallidotomy, thalamotomy)
- Any participant deemed ineligible by the investigator, including those with medical conditions that may increase risk or interfere with study evaluation
- Currently enrolled in another clinical trial or used investigational drug/device within 30 days or 5 half-lives prior to consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Real rTMS
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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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.
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假比较器：Sham rTMS
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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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Beck Depression Inventory-II (BDI-II) Total Score
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Self-reported measure of depressive symptom severity consisting of 21 items rated on a 4-point Likert scale.
Higher scores indicate greater depression severity.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Neuropsychiatric Inventory (NPI) Scores
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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).
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Parkinson's Disease Sleep Scale (PDSS) Scores
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Toronto Alexithymia Scale-20 Korean Version (TAS-20-K) Scores
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Montreal Cognitive Assessment (MoCA) Scores
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Facial Expression Measures on FaceReader Analysis
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Eye Movement Measures on Eye-Tracking
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Muscle Activity Measured by Electromyography (EMG)
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Postural Stability and Balance Measures on BT4 Balance Assessment
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Body Composition Measured by Bioelectrical Impedance Analysis (InBody)
大体时间：Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Brain Structure and Connectivity on MRI
大体时间：Change from Baseline (T0) at 1 week (T1) after stimulation
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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.
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Change from Baseline (T0) at 1 week (T1) after stimulation
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Change in Plasma Biomarker Concentrations
大体时间：Change from Baseline (T0) at 1 week (T1) after stimulation
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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).
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Change from Baseline (T0) at 1 week (T1) after stimulation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Howon Lee, MD、Kyungpook National University Chilgok Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月4日
初级完成 (估计的)
2026年10月23日
研究完成 (估计的)
2026年10月23日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
2026年5月6日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KNUCH 2025-08-046-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.