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

NCT07569133 | Enrolling By Invitation

• 1 other identifier: KNUCH 2025-08-046-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson's Disease; Depression

Keywords

rTMS; Digital Biomarkers; Neuronavigation; Motor Cortex; Neurodegeneration

Outcome Measures

Primary Outcomes (2)

• Beck Depression Inventory-II (BDI-II)

  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)

  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)

Secondary Outcomes (12)

• Parkinson's Disease Questionnaire-39 (PDQ-39)

  Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)

• Parkinson's Disease Sleep Scale (PDSS)

  Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)

• Toronto Alexithymia Scale-20 Korean Version (TAS20-K)

  Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)

• Montreal Cognitive Assessment (MoCA)

  Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)

Study Arms (2)

Real rTMS

EXPERIMENTAL

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.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS

SHAM COMPARATOR

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.

Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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.

Real rTMS

Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS) DEVICE

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.

Sham rTMS

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ho-Won Lee: lead
• Korea Brain Research Institute: collaborator

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, Buk-gu, 41404, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease; Depression; Nerve Degeneration

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Howon Lee, MD

  Kyungpook National University Chilgok Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Neurology

Model Details: Participants are randomly assigned to either real rTMS or sham rTMS group. Both groups continue their existing Parkinson's disease medication throughout the study.

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)