Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Mild to Moderate Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
研究概览
简要总结
The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40-79 y
- •Idiopathic Parkinson's Disease Diagnosis
- •Disease Stage: Hoehn and Yahr stage 2-3
- •Patient requires a minimum of 3 doses of levodopa daily
- •Willingness to be videotaped
- •Exclusion criteria:
- •Dementia or Montreal Cognitive Assessment score <24
- •Parkinson's Disease psychosis
- •Ear trauma
- •Facial pain
- •Traumatic Brain Injury or clinical history of stroke
- •Metal implants above the shoulders
- •History of myocardial infarction or arrhythmia, bradycardia
- •Active respiratory disorder
- •Alcohol or substance use disorders
- •History of Deep Brain Stimulation (DBS) or other brain surgery
- •Pregnancy
- •B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs
排除标准
- 未提供
结局指标
主要结局
Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
时间窗: Baseline (Visit 1) to Day 14 (Visit 10)
The MDS-UPDRS is a rating scale used in research and clinic to rate the severity of Parkinson's Disease. A low score indicates mild disease and a high score more advanced disease. The possible range for MDS-UPDRS Part III is 0-132. Higher scores reflect greater motor disturbance. A decline in score from pre-post would indicate improvement. This outcome observed Part III of UPDRS motor examination. Information on cover page: The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). Part I has two components: IA concerns a number of behaviors that are assessed by the investigator with all pertinent information from patients and caregivers, and IB is completed by the patient with or without the aid of the caregiver, but independently of the investigator. These sections can, however, be reviewed by the rater to ensure that all questions are answered clea
次要结局
- Change in Cognitive Function Score(Screening to Day 13 (Visit 9))
研究者
Vanessa Hinson
Program Director
Medical University of South Carolina