An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) and Sham Repetitive Transcranial Magnetic Stimulation (Sham rTMS) in Parkinson's Disease and Depression, sponsored by Ho-Won Lee. Enrolling by invitation at 1 site in South Korea. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Ho-Won Lee · Not applicable, Interventional, and Treatment
Among 76 studies in Parkinson Disease with a site in Korea, Republic of — 13 open to participants now, 15 under way, 1 of them phase 3. Parkinson Disease · Korea, Republic of.
Among the 76 studies in Parkinson Disease with a site in Korea, Republic of, this one is the 35th largest by planned enrollment of the 67 interventional ones, is one of 6 that started in 2026, is one of 28 with no phase, reaches primary completion later than 3 of the 14 other live ones, and was the 74th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →13 of the 76 studies in Parkinson Disease with a site in Korea, Republic of are open now, in 12 countries. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 40 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →76 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 6 started in 2026.
Median enrollment 60 across the 67 interventional studies, 500 across the 9 observational. Of the 45 that completed or were terminated, 12 (27%) have results posted.
28 of 76 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Ho-Won Lee as lead sponsor.
Ho-Won Lee has 1 study filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in Parkinson Disease with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07569133Ho-Won LeeEfficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease | 2026-11-27 |
| NCT07522138Seoul National University HospitalHome-based Self-exercise in Patients With Parkinson's Disease: A Feasibility Study | 2026-12-01 |
| NCT01799915NYU Langone HealthNatural History Study of Synucleinopathies | 2026-12-30 |
Among the 76 studies in Parkinson Disease with a site in Korea, Republic of, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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 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.
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).
Time frame: 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).
Time frame: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, immediately after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline, 1 week (±2 days) after the final stimulation session, and 4 weeks (±7 days) after the final stimulation session
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.
Time frame: Baseline and 1 week (±2 days) after the final stimulation session
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).
Time frame: Baseline and immediately after the final stimulation session
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.
Time frame: 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
Plan to share: 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.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 6 months is below that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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