Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
2026년 4월 28일 업데이트: 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.
연구 개요
상태
초대로 등록
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Buk-gu
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Daegu, Buk-gu, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Beck Depression Inventory-II (BDI-II)
기간: 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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Neuropsychiatric Inventory (NPI)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Parkinson's Disease Questionnaire-39 (PDQ-39)
기간: 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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Unified Parkinson's Disease Rating Scale (UPDRS)
기간: 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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Parkinson's Disease Sleep Scale (PDSS)
기간: 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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Toronto Alexithymia Scale-20 Korean Version (TAS20-K)
기간: 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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Montreal Cognitive Assessment (MoCA)
기간: 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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Facial Expression Analysis (FaceReader)
기간: 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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Eye Movement Assessment (Eye-tracking)
기간: 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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Electromyography (EMG)
기간: 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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Static Balance Assessment (BT4)
기간: 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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Body Composition Analysis (InBody)
기간: 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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Brain Structural and Functional MRI
기간: 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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Blood-based biomarkers
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Howon Lee, MD, Kyungpook National University Chilgok Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 4일
기본 완료 (추정된)
2026년 10월 23일
연구 완료 (추정된)
2026년 10월 23일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 28일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KNUCH 2025-08-046-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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