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Parkinson's DiseaseNCT07569133

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

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Parkinson's Disease and Depression, run by Ho-Won Lee at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Parkinson's Disease, Depression
What is being tested?
Repetitive Transcranial Magnetic Stimulation (rTMS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteSouth Korea
Study dates
4 May 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site
  • Kyungpook National University Chilgok Hospital

    Daegu, Buk-gu, 41404

Other trials in South Korea

About this study

Official title: Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease : A Single-Center, Randomized, Double-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 evaluate the efficacy and feasibility of a neuronavigation-guided bilateral M1 rTMS protocol.

Read the detailed description

Antidepressants and other psychotropic medications must have been stable for 4 weeks before baseline and remain unchanged during the study

At each clinical assessment, the time of the most recent dopaminergic medication dose and the participant's clinical medication state (ON or OFF) will be recorded. Whenever feasible, follow-up assessments will be performed at a similar time relative to the participant's usual dopaminergic medication schedule as at baseline.

Being tested
Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)
Keywords
rTMS, Digital Biomarkers, Neuronavigation, Motor Cortex, Neurodegeneration
Medical subject headings
Parkinson Disease, Depression, Nerve Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT07569133
Study groupRoleWhat they receive
Real rTMSExperimentalParticipants 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.
Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMSSham comparatorParticipants 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.
Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score

    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).

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  2. Change From Baseline in Neuropsychiatric Inventory (NPI) Scores

    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).

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

Secondary outcomes (14)
  1. Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores

    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.

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores

    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.

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  3. Change in Parkinson's Disease Sleep Scale (PDSS) Scores

    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.

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  4. Change in Toronto Alexithymia Scale-20 Korean Version (TAS-20-K) Scores

    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.

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  5. Change in Montreal Cognitive Assessment (MoCA) Scores

    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.

    Measured: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  6. Change in Facial Expression Measures on FaceReader Analysis

    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.

    Measured: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  7. Change in Eye Movement Measures on Eye-Tracking

    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.

    Measured: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  8. Change in Muscle Activity Measured by Electromyography (EMG)

    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.

    Measured: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  9. Change in Postural Stability and Balance Measures on BT4 Balance Assessment

    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.

    Measured: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  10. Change in Body Composition Measured by Bioelectrical Impedance Analysis (InBody)

    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.

    Measured: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  11. Change in Electrodermal Activity Measured by Galvanic Skin Response (GSR)

    Electrodermal activity is measured using the Shimmer Consensys GSR Development Kit, which records skin conductance changes between electrodes via wireless sensors. Sweat gland activation in response to internal or external stimuli alters skin moisture and ionic balance, producing measurable changes in electrodermal activity.

    Measured: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

  12. Change in Brain Structure and Connectivity on MRI

    Neuroimaging assessment of brain structure using MRI with two sequences: T1-weighted and T2-weighted structural imaging. Used to evaluate structural changes before and after rTMS treatment, and to guide neuronavigation-based TMS targeting.

    Measured: Baseline and 1 week (±2 days) after the final stimulation session

  13. Change in Plasma Biomarker Concentrations

    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).

    Measured: Baseline and immediately after the final stimulation session

  14. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Safety will be assessed by the number and proportion of participants experiencing treatment-emergent adverse events (TEAEs) from the initiation of rTMS or sham stimulation through the final follow-up assessment. Adverse events will be summarized by event type, severity, and relationship to the investigational device. Serious adverse events, adverse device effects, and discontinuations due to adverse events will also be recorded and summarized by treatment group.

    Measured: From the first stimulation session to the final stimulation session, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start4 May 2026
  3. Primary completion27 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to either real rTMS or sham rTMS group. Both groups continue their existing Parkinson's disease medication throughout the study.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569133
Sponsor's protocol ID
KNUCH 2025-08-046-006
Status last verified
Oct 2026
First submitted
28 Apr 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Parkinson's Disease and Depression, run by Ho-Won Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score (time frame: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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