Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Repetitive Transcranial Magnetic Stimulation (rTMS)
  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.
• Устройство Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)
  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.

Первичные конечные точки

• Change in Beck Depression Inventory-II (BDI-II) Total Score [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Neuropsychiatric Inventory (NPI) Scores [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]

Вторичные конечные точки (12)

• Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Parkinson's Disease Sleep Scale (PDSS) Scores [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Toronto Alexithymia Scale-20 Korean Version (TAS-20-K) Scores [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Montreal Cognitive Assessment (MoCA) Scores [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Facial Expression Measures on FaceReader Analysis [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Eye Movement Measures on Eye-Tracking [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Muscle Activity Measured by Electromyography (EMG) [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Postural Stability and Balance Measures on BT4 Balance Assessment [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Body Composition Measured by Bioelectrical Impedance Analysis (InBody) [Срок оценки: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
• Change in Brain Structure and Connectivity on MRI [Срок оценки: Change from Baseline (T0) at 1 week (T1) after stimulation]
• Change in Plasma Biomarker Concentrations [Срок оценки: Change from Baseline (T0) at 1 week (T1) after stimulation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Kyungpook National University Chilgok Hospital — Daegu

Идентификаторы

NCT: NCT07569133 · KNUCH 2025-08-046-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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