Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
3 de agosto de 2026 atualizado por: Ho-Won Lee
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
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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
50
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Buk-gu
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Daegu, Buk-gu, Coréia do Sul, 41404
- Kyungpook National University Chilgok Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Real rTMS
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.
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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.
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Comparador Falso: Sham 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Beck Depression Inventory-II (BDI-II) Total Score
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Self-reported measure of depressive symptom severity consisting of 21 items rated on a 4-point Likert scale.
Higher scores indicate greater depression severity.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Neuropsychiatric Inventory (NPI) Scores
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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).
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Parkinson's Disease Questionnaire-39 (PDQ-39) Scores
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Parkinson's Disease Sleep Scale (PDSS) Scores
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Toronto Alexithymia Scale-20 Korean Version (TAS-20-K) Scores
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Montreal Cognitive Assessment (MoCA) Scores
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Facial Expression Measures on FaceReader Analysis
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Eye Movement Measures on Eye-Tracking
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Muscle Activity Measured by Electromyography (EMG)
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Postural Stability and Balance Measures on BT4 Balance Assessment
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Body Composition Measured by Bioelectrical Impedance Analysis (InBody)
Prazo: Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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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.
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Change from Baseline (T0) at 1 week (T1) and 5 weeks (T2, 1-month follow-up)
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Change in Brain Structure and Connectivity on MRI
Prazo: Change from Baseline (T0) at 1 week (T1) after stimulation
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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.
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Change from Baseline (T0) at 1 week (T1) after stimulation
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Change in Plasma Biomarker Concentrations
Prazo: Change from Baseline (T0) at 1 week (T1) after stimulation
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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).
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Change from Baseline (T0) at 1 week (T1) after stimulation
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Howon Lee, MD, Kyungpook National University Chilgok Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de maio de 2026
Conclusão Primária (Estimado)
23 de outubro de 2026
Conclusão do estudo (Estimado)
23 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de abril de 2026
Primeira postagem (Real)
6 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sinucleinopatias
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Processos Patológicos
- Sintomas Comportamentais
- Doenças Neurodegenerativas
- Distúrbios do Movimento
- Distúrbios parkinsonianos
- Doenças dos Gânglios da Base
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Depressão
- Doença de Parkinson
- Degeneração Nervosa
- Terapêutica
- Terapia de campo magnético
- Estimulação magnética transcraniana
Outros números de identificação do estudo
- KNUCH 2025-08-046-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .