NCT07839481尚未招募不适用
Effects of Home-Based Transcutaneous Cervical Vagus Nerve Stimulation (tcVNS) on Clinical Symptoms and Neurophysiological Biomarkers in Patients With Parkinson's Disease: A Proof-of-Concept Clinical Trial
Kyoungwon Baik0 个研究点目标入组 15 人开始时间: 2026年9月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Change in MDS-NMS total score
研究概览
简要总结
The goal of this clinical trial is to learn if home-based transcutaneous cervical vagus nerve stimulation (tcVNS) can improve symptoms in adults with Parkinson's disease. tcVNS uses a small portable device placed on the skin of the left side of the neck to deliver mild electrical stimulation. It does not require surgery or anesthesia.
The main questions it aims to answer are:
- Does tcVNS reduce non-motor symptoms of Parkinson's disease, such as sleep problems, low mood, anxiety, digestive problems, and fatigue?
- Does tcVNS change movement symptoms, memory and thinking, brain wave activity, heart rhythm patterns, and markers of inflammation in the blood?
- Can participants use the device safely on their own at home every day, and what medical problems do they have while using it?
Everyone in this study will use the same stimulation device. There is no placebo group. Researchers will compare each participant's own measurements taken before stimulation, after 4 weeks of stimulation, and again after a 4-week break, to see whether symptoms change and whether any change lasts.
Participants will:
- Use the stimulation device on the neck for 30 minutes once a day, at home, every day for 4 weeks. The first session is done at the clinic with study staff, who teach participants how to use the device.
- Visit the clinic 6 times over about 9 weeks for physical and neurological checkups, questionnaires about their symptoms, memory and thinking tests, brain wave recordings (EEG), and heart rhythm recordings (HRV).
- Give a blood sample of about 10 mL at 3 of the visits (about 30 mL in total) so researchers can measure markers of inflammation.
- Have a brain MRI scan at 2 of the visits, at centers where MRI is available.
- Keep a record of their device use in a paper diary or a smartphone app. The device also records use times automatically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease diagnosed according to the UK Brain Bank criteria and the MDS Clinical Diagnostic Criteria for Parkinson's Disease
- •Hoehn and Yahr stage I to III, assessed in the ON state
- •Aged 20 to 79 years
- •If taking antiparkinsonian medication (e.g., levodopa, dopamine agonists), on a stable regimen for at least 4 weeks before enrollment
- •Willing to participate voluntarily and able to provide written informed consent
- •Able to attend the scheduled study visits and to perform the home-based intervention throughout the study period
排除标准
- •Secondary parkinsonism (e.g., vascular, drug-induced, multiple system atrophy) or an atypical parkinsonian syndrome
- •Presence of a deep brain stimulation (DBS) device, or planned DBS surgery during the study period
- •Active cardiac arrhythmia, or presence of an implanted cardiac pacemaker or an implantable cardioverter-defibrillator (ICD), which are contraindications to vagus nerve stimulation
- •History of open surgery of the neck, or history of cervical nerve injury
- •Active epilepsy, or a seizure within the past year
- •Dementia, or inability to provide independent informed consent
- •Active psychiatric illness, including schizophrenia, acute-phase bipolar disorder, or severe depression with suicidal risk
- •Intracranial lesions such as stroke, brain tumor, or hydrocephalus
- •Contraindications to MRI, such as cerebral aneurysm clips, cochlear implants, or other ferromagnetic foreign bodies; metallic joint prostheses are assessed on a case-by-case basis
- •Pregnant or breastfeeding women, and women of childbearing potential who plan to become pregnant during the study or who are not using adequate contraception
- •Participation in another clinical trial within the past 3 months
- •History of alcohol or substance abuse within the past 6 months
- •Any other condition that, in the judgment of the investigator, makes the participant unsuitable for study participation
研究组 & 干预措施
Treatment arm
Experimental
干预措施: transcutaneous vagus nerve stimulation (Device)
结局指标
主要结局
Change in MDS-NMS total score
时间窗: Baseline and Week 5 (immediately after the 4-week stimulation period)
The Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) assesses the severity and frequency of non-motor symptoms in Parkinson's disease across multiple domains. Total score range \[0-832\]; higher scores indicate greater non-motor symptom burden.
次要结局
- Change in MDS-UPDRS Part I score(Baseline, Week 5, and Week 9)
- Change in MDS-UPDRS Part II score(Baseline, Week 5, and Week 9)
- Change in MDS-UPDRS Part III score(Baseline, Week 5, and Week 9)
- Change in Mini-Mental State Examination (MMSE) score(Baseline, Week 5, and Week 9)
- Change in Montreal Cognitive Assessment (MoCA) score(Baseline, Week 5, and Week 9)
- Change in Pittsburgh Sleep Quality Index (PSQI) global score(Baseline, Week 5, and Week 9)
- Change in REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score(Baseline, Week 5, and Week 9)
- Change in Epworth Sleepiness Scale (ESS) score(Baseline, Week 5, and Week 9)
- Change in Geriatric Depression Scale (GDS) score(Baseline, Week 5, and Week 9)
- Change in State-Trait Anxiety Inventory (STAI) State subscale score(Baseline, Week 5, and Week 9)
- Change in GIDS-PD score(Baseline, Week 5, and Week 9)
- Number of participants with adverse events and serious adverse events(From informed consent through Week 9)
- Adherence to home-based stimulation(Over the 4-week stimulation period (Week 1 to Week 5))
研究者
Kyoungwon Baik
Clinical Assistant Professor
Korea University Anam Hospital
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