Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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

28. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Falešný srovnávač: 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.
Přístroj: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Beck Depression Inventory-II (BDI-II)
Časové okno: 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)
Neuropsychiatric Inventory (NPI)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Parkinson's Disease Questionnaire-39 (PDQ-39)
Časové okno: 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)
Unified Parkinson's Disease Rating Scale (UPDRS)
Časové okno: 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)
Parkinson's Disease Sleep Scale (PDSS)
Časové okno: 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)
Toronto Alexithymia Scale-20 Korean Version (TAS20-K)
Časové okno: 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)
Montreal Cognitive Assessment (MoCA)
Časové okno: 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)
Facial Expression Analysis (FaceReader)
Časové okno: 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)
Eye Movement Assessment (Eye-tracking)
Časové okno: 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)
Electromyography (EMG)
Časové okno: 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)
Static Balance Assessment (BT4)
Časové okno: 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)
Body Composition Analysis (InBody)
Časové okno: 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)
Brain Structural and Functional MRI
Časové okno: 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
Blood-based biomarkers
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ho-Won Lee

Spolupracovníci

Korea Brain Research Institute

Vyšetřovatelé

  • Vrchní vyšetřovatel: Howon Lee, MD, Kyungpook National University Chilgok Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

4. května 2026

Primární dokončení (Odhadovaný)

23. října 2026

Dokončení studie (Odhadovaný)

23. října 2026

Termíny zápisu do studia

První předloženo

28. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

28. dubna 2026

První zveřejněno (Aktuální)

6. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KNUCH 2025-08-046-001

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Repetitive Transcranial Magnetic Stimulation (rTMS)

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Guatemala

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit