A Randomized Double-Blind Active-Controlled Crossover Trial of Respiratory-Gated Versus Non-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Unified Parkinson's Disease Rating Scale Part III (UPDRS-III)
研究概览
简要总结
The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) on motor and non-motor symptoms in people with Parkinson's disease. The main questions it aims to answer are:
Which mode and frequency of taVNS is most effective in improving motor or non-motor symptoms? Are there any side effects or safety concerns with different taVNS frequencies? Researchers will compare three types of taVNS: 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation.
Participants will:
Receive each type of taVNS in three 2-week cycles, with 2-month breaks between cycles Undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.
详细描述
This study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS). The interventions include: 25 Hz non-expiratory gated taVNS, 25 Hz expiratory gated taVNS, and 100 Hz expiratory gated taVNS. Participants will be randomly assigned to one of three groups, with each group receiving a different intervention during each cycle, lasting 2 weeks per cycle. A 2-month washout period will be implemented between cycles to eliminate any carryover effects.The study design will include neuropsychological assessments, imaging, eye-tracking data collection, and biological specimen collection before and after each intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40 years or older.
- •Confirmed diagnosis of Parkinson's disease (PD) per the United Kingdom Brain Bank Criteria by a neurologist specialized in movement disorders.
- •Participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-PD medications for the next 3 months.
- •In the second version of the Non-Motor Symptoms Scale (NMSS-2) for Parkinson's disease, a score of ≥1 is assigned to either question 4 or question
- •Participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation.
排除标准
- •Mini-Mental State Examination (MMSE) score <
- •History of head injury, stroke, or other neurological disorders.
- •Includes implanted cardiac pacemakers post-DBS operation, local infections, ear loss, or metal implants at the stimulation site.
- •Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
- •Inability to complete follow-up assessments.
研究组 & 干预措施
25 Hz non-expiratory gated taVNS
25 Hz non-expiratory gated transcutaneous auricular vagus nerve stimulation
干预措施: Transcutaneous auricular vagus nerve stimulation (Other)
25 Hz expiratory gated taVNS
25 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
干预措施: Transcutaneous auricular vagus nerve stimulation (Other)
100 Hz expiratory gated taVNS
100 Hz expiratory gated transcutaneous auricular vagus nerve stimulation
干预措施: Transcutaneous auricular vagus nerve stimulation (Other)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale Part III (UPDRS-III)
时间窗: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III) is the gold standard, clinician-administered motor examination for Parkinson's disease. It is a semi-quantitative scale comprising 18 items assessing core motor features-tremor, rigidity, bradykinesia, and postural/gait dysfunction. Each item is scored from 0 (normal) to 4 (severe), with a total possible score of 108. As the primary endpoint in clinical trials, it objectively quantifies motor disability severity and treatment response.
Non-Motor Symptoms Scale, Second Version (NMSS-2)
时间窗: Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks
The NMSS-2 is a comprehensive, clinician-administered tool designed to assess the range and severity of non-motor symptoms in individuals with Parkinson's disease. It covers multiple domains including sleep disturbances, mood, cognition, gastrointestinal symptoms, urinary dysfunction, and other non-motor manifestations. This second version of the scale provides an updated and refined assessment framework to capture the broad impact of non-motor symptoms on patients' quality of life.
次要结局
- Apathy Motivation Index (AMI)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- Apathy Evaluation Scale (AES)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- Fatigue Scale-14 (FS-14)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- Hamilton Anxiety Rating Scale (HAMA)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- Hamilton Depression Rating Scale (HAMD-17)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
- Epworth Sleepiness Scale (ESS)(Baseline;2 weeks; 10 weeks; 12 weeks;20 weeks;22weeks)
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University