NCT07569133

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 28, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 4, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

April 28, 2026

Last Update Submit

September 22, 2026

Conditions

Parkinson's DiseaseDepression

Keywords

rTMSDigital BiomarkersNeuronavigationMotor CortexNeurodegeneration

Outcome Measures

Primary Outcomes (2)

  • 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).

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

  • 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).

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

Secondary Outcomes (14)

  • Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores

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

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

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

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

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

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

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

  • Change in Montreal Cognitive Assessment (MoCA) Scores

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

  • +9 more secondary outcomes

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

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

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)
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, Buk-gu, 41404, South Korea

Location

MeSH Terms

Conditions

Parkinson DiseaseDepressionNerve Degeneration

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Ho-Won 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
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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Neurology

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 6, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

November 27, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

KR(1)