A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- MDS-UPDRS-Ⅲ
研究概览
简要总结
This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.
详细描述
This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease, , aiming to investigate a novel therapeutic approach for delaying PD progression.
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
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55-75 years.
- •Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
- •Hoehn and Yahr (H&Y) stage ≤ 2.5 at medication initiation.
- •Parkinson's disease duration ≤ 3 years.
- •Receiving standard anti-Parkinson's disease medication treatment.
排除标准
- •Patients with cognitive impairment (MMSE < 24 and/or MoCA < 26) or mental illnesses, or those unable to cooperate for other reasons.
- •Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-
- •Use of any medications that may affect dopamine metabolism and/or dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors.
- •Previous treatment with vagus nerve stimulation.
- •MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts > 1 cm³ or > 3 lacunar infarcts.
- •Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation.
- •Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related.
- •Previous history of stroke or intracranial mass lesions.
- •Patients with existing or potential cardiovascular diseases.
- •Ophthalmic diseases affecting eye movements.
- •Any neurological disorders other than Parkinsonian motor symptoms that interfere with gait or balance (e.g., chronic pain) or musculoskeletal injuries (e.g., fractures, stroke sequelae).
- •Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years.
- •Concurrent participation in other clinical trials.
- •Inability to receive the required treatment and follow-up due to geographic reasons.
- •Any subject with an upper limb UPDRS tremor score of 3 or higher.
- •Patients with a history of PD-related freezing episodes or falls.
研究组 & 干预措施
Standard anti-Parkinson's disease medication treatment + taVNS real stimulation
For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba.
Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days.
干预措施: taVNS real stimulation (Device)
Standard anti-Parkinson's disease medication treatment + taVNS sham stimulation
For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days.
干预措施: taVNS sham stimulation (Device)
结局指标
主要结局
MDS-UPDRS-Ⅲ
时间窗: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days
Used to evaluate the motor function.
Free water in the posterior substantia nigra (DTI)
时间窗: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days
Used to measure progression of early Parkinson's disease.
次要结局
- Scales: MDS-UPDRS-II(baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days)
- Step Length、Stride Length、Stride Velocity and Step Length Variability(baseline,180±7 days, 360±7 days, 540±7 days，570±7 days)
- Scales: H&Y stage(baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days)
研究者
Kezhong Zhang
Professor
The First Affiliated Hospital with Nanjing Medical University