Respiratory-gated Transcutaneous Auricular Vagus Nerve Stimulation for Improving Apathy in Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Apathy Motivation Index (AMI)
研究概览
简要总结
The goal of this clinical trial is to learn whether 100HZ respiratory-gated vagus nerve stimulation (RAVANS) can improve the non-motor symptoms in people with Parkinson's disease (PD). It will also learn the safety of 100HZ RAVANS. The main questions it aims to answer are:
Can 100HZ RAVANS improve apathy in people with PD? Did the participants have any side effects or safety issues when undergoing 100HZ RAVANS? Researchers compared 100HZ RAVANS with sham stimulation (low-dose stimulation of the same site and treatment parameters) to see if 100HZ RAVANS could improve non-motor symptoms in patients with PD.
Participants will:
Receive 100HZ RAVANS or sham stimulation for 2 weeks. Neuropsychological assessment, imaging and biological sample collection were conducted before and after the entire cycle.
详细描述
This study employs a double-blind, sham-controlled design to further validate the effects of 100Hz RAVANS on apathy . Patients were randomized into real or sham stimulation groups. Both groups will receive RAVANS once daily, with each session lasting 30 minutes, for a total duration of two weeks. The study design will include neuropsychological assessments, imaging, and biological specimen collection before and after the entire cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015 version)).
- •Patients with Apathy Motivation Index (AMI) score >1.
- •All PD patients must be on stable, standardized medication regimens with no adjustments to medications for at least 1 month prior to the study and throughout the study period.
- •Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy.
- •Mini-Mental State Examination (MMSE) score ≥
- •Meet safety criteria for MRI screening.
排除标准
- •Prior brain MRI/CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or higher).
- •Secondary parkinsonism (e.g., vascular parkinsonism, drug-induced parkinsonism).
- •History of severe traumatic brain injury, neurosurgery, or deep brain stimulation (DBS) therapy.
- •Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure control.
- •Diagnosis of neuropsychiatric disorders other than Parkinson's disease.
- •Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or Non-benzodiazepine GABA receptor agonist drug or anticholinergics or corticosteroids, or history of substance abuse or drug addiction.
- •Participation in any clinical trial within the past 3 months.
- •Severe systemic comorbidities (e.g., hepatic/renal failure, arrhythmias, organic heart disease).
- •Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months.
- •Contraindications to taVNS, such as cardiac pacemakers, post-DBS surgery, or auricular pathologies (e.g., tympanic membrane perforation).
研究组 & 干预措施
Active respiratory-gated transcutaneous auricular vagus nerve stimulation (RAVANS)
Participants will receive active RAVANS daily for 2 week.
干预措施: Active RAVANS (Other)
Sham RAVANS
Participants will receive sham RAVANS daily for 2 week.
干预措施: Sham RAVANS (Other)
结局指标
主要结局
Apathy Motivation Index (AMI)
时间窗: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
The AMI is used to assess levels of apathy across behavioral, emotional, and cognitive domains. It provides a comprehensive measure of motivation deficits.
Apathy Motivation Index (AMI)
时间窗: baseline; 2 weeks; 6weeks; 8weeks; 10 weeks
The AMI is used to assess levels of apathy across behavioral, emotional, and cognitive domains. It provides a comprehensive measure of motivation deficits.
次要结局
- Non-Motor Symptoms Scale, Second Version (NMSS-2)(baseline; 2 weeks; 6weeks; 8weeks; 10 weeks)
- AMI subscales(baseline; 2 weeks; 6weeks; 8weeks; 10 weeks)
- Epworth Sleepiness Scale (ESS)(baseline; 2 weeks; 10 weeks)
- Fatigue Scale-14 (FS-14)(baseline; 2 weeks; 10 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(baseline; 2 weeks; 10 weeks)
- REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)(baseline; 2 weeks; 10 weeks)
- The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III)(baseline; 2 weeks; 10 weeks)
- The Neuropsychiatric Inventory (NPI)(baseline; 2 weeks; 10 weeks)
- The Hamilton Anxiety Rating Scale (HAMA)(baseline; 2 weeks; 10 weeks)
- The Hamilton Depression Rating Scale (HAMD)(baseline; 2 weeks; 10 weeks)
- Heart Rate Variability (HRV)(baseline everyday; during the intervention everyday)
- Behavioral performance and computational parameters in an effort-based decision-making task(baseline; 2 weeks)
- Non-Motor Symptoms Scale, Second Version (NMSS-2)(baseline; 2 weeks; 6weeks; 8weeks; 10 weeks)
- The Hamilton Anxiety Rating Scale (HAMA)(baseline; 2 weeks; 10 weeks)
- The Hamilton Depression Rating Scale (HAMD)(baseline; 2 weeks; 10 weeks)
- AMI subscales(baseline; 2 weeks; 6weeks; 8weeks; 10 weeks)
- Epworth Sleepiness Scale (ESS)(baseline; 2 weeks; 10 weeks)
- Fatigue Scale-14 (FS-14)(baseline; 2 weeks; 10 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(baseline; 2 weeks; 10 weeks)
- REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)(baseline; 2 weeks; 10 weeks)
- The Unified Parkinson's Disease Rating Scale, Part III (UPDRS-III)(baseline; 2 weeks; 10 weeks)
- Heart Rate Variability (HRV)(baseline everyday; during the intervention everyday)
- The Neuropsychiatric Inventory (NPI)(baseline; 2 weeks; 10 weeks)
- Behavioral performance and computational parameters in an effort-based decision-making task(baseline; 2 weeks)
研究者
WANG KAI
Head of the Department, Department of Neurology, The First Affiliated Hospital of Anhui Medical University
Anhui Medical University