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

3. august 2026 oppdatert av: 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.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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-komparator: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Beck Depression Inventory-II (BDI-II) Total Score
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ho-Won Lee

Samarbeidspartnere

Korea Brain Research Institute

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. mai 2026

Primær fullføring (Antatt)

23. oktober 2026

Studiet fullført (Antatt)

23. oktober 2026

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KNUCH 2025-08-046-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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