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Enrolling by invitation Not applicable

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

NCT07569133 · tracked via the Priya Life Science South Korea tracker
Sponsor
Ho-Won Lee
Phase
Not applicable
Started
2026-05-04
Last updated
2026-09-24

Condition(s) studied

Parkinson's DiseaseDepression

Investigational drug(s) / intervention(s)

Repetitive Transcranial Magnetic Stimulation (rTMS)Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)

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 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.

Study summary

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 evaluate the efficacy and feasibility of a neuronavigation-guided bilateral M1 rTMS protocol.

Eligibility

Sex
ALL
Min age
40 Years
Max age
90 Years
Healthy volunteers
No
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 * Clinically significant depressive symptoms (BDI-II score ≥14) confirmed by clinician interview, without major psychiatric conditions that may confound their assessment * 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) * Major psychiatric disorders other than depressive disorders (e.g., bipolar disorder, psychotic disorders) that may interfere with study participation or assessment of depressive symptoms * 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

Primary outcome measure(s)

  • Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score — Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
    The BDI-II is a 21-item self-reported questionnaire assessing the severity of depressive symptoms. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63, with higher scores indicating greater severity of depressive symptoms. Changes in BDI-II total score from baseline (T0) will be compared between the real rTMS and sham rTMS groups after treatment (T1) and at the follow-up assessment (T2).
  • Change From Baseline in Neuropsychiatric Inventory (NPI) Scores — Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
    The NPI is a caregiver- or informant-based assessment of neuropsychiatric symptoms. It evaluates 12 neuropsychiatric symptom domains based on symptom frequency and severity. Changes in NPI scores from baseline (T0) will be compared between the real rTMS and sham rTMS groups after treatment (T1) and at the follow-up assessment (T2).

Trial sites (1)

FacilityCityRegionStatus
Kyungpook National University Chilgok Hospital Daegu Buk-gu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07569133 on ClinicalTrials.gov ↗ ← All trials in South Korea