Kyungpook National University Chilgok Hospital
Daegu, Buk-gu, 41404, South Korea
NCT Number: NCT07569133
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.
Interested in participating?
Request Info40 year–90 year
All sexes
Interventional
Not applicable
Daegu, Buk-gu, 41404, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
Self-reported measure of depressive symptom severity consisting of 21 items rated on a 4-point Likert scale. Higher scores indicate greater depression severity.
Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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).
Time frame: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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: Change from Baseline (T0) at 1 week (T1) after stimulation
Neuroimaging assessment of brain structure and function using MRI with three sequences: T1-weighted and T2-weighted structural imaging, and Diffusion Tensor Imaging (DTI) to assess white matter integrity and structural connectivity. Used to evaluate changes in brain structure before and after rTMS treatment, and to guide neuronavigation-based TMS targeting.
Time frame: Change from Baseline (T0) at 1 week (T1) after stimulation
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).
Ho-Won Lee
Other
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
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