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Enrolling by invitation NCT07569133

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

No phase Interventional Parkinson's Disease Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS).
Who it may be relevant to
Registry conditions: Parkinson's Disease, Depression. Basic parameters: 40 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Change in Beck Depression Inventory-II (BDI-II) Total Score [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
  • Change in Neuropsychiatric Inventory (NPI) Scores [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
Secondary outcome measures (12)
  • Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
  • Change in Montreal Cognitive Assessment (MoCA) Scores [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
  • Change in Facial Expression Measures on FaceReader Analysis [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
  • Change in Eye Movement Measures on Eye-Tracking [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
  • Change in Muscle Activity Measured by Electromyography (EMG) [Time frame: 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 [Time frame: 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) [Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)]
  • Change in Brain Structure and Connectivity on MRI [Time frame: Change from Baseline (T0) at 1 week (T1) after stimulation]
  • Change in Plasma Biomarker Concentrations [Time frame: Change from Baseline (T0) at 1 week (T1) after stimulation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Kyungpook National University Chilgok Hospital — Daegu

Identifiers

NCT: NCT07569133 · KNUCH 2025-08-046-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗