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

2026. augusztus 3. frissítette: 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.

A tanulmány áttekintése

Állapot

Jelentkezés meghívóval

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

50

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Dél -Korea
    • Buk-gu
      • Daegu, Buk-gu, Dél -Korea, 41404
        • Kyungpook National University Chilgok Hospital

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Kettős

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Eszköz: 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.
Sham Comparator: 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.
Eszköz: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Beck Depression Inventory-II (BDI-II) Total Score
Időkeret: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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)
Change in Neuropsychiatric Inventory (NPI) Scores
Időkeret: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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)

Másodlagos eredményintézkedések

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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Ho-Won Lee

Együttműködők

Korea Brain Research Institute

Nyomozók

  • Kutatásvezető: Howon Lee, MD, Kyungpook National University Chilgok Hospital

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. május 4.

Elsődleges befejezés (Becsült)

2026. október 23.

A tanulmány befejezése (Becsült)

2026. október 23.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 28.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 28.

Első közzététel (Tényleges)

2026. május 6.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 5.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 3.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • KNUCH 2025-08-046-001

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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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