The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change of Hamilton Anxiety Scale Score
研究概览
简要总结
This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with anxiety. The investigators hypothesize that taVNS will improve anxiety and cortical activity in Parkinson's disease patients with anxiety.
详细描述
Participants in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas participants in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of anxiety symptoms, motor symptoms were performed three times: at baseline, one day post intervention and 2 weeks post intervention. The cortical activity (using Functional near-infrared spectroscopy) were assessed at baseline, one day post 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, Investigator)
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
- 是
入选标准
- •(1) diagnosed with idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD;
- •(2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for anxiety and Hamilton Anxiety Scale (HAMA) score ≥ 12;
- •(3) stable pharmacotherapy for PD at least one month prior to the study;
- •(4) 40-80 years old;
- •(5) willing to sign written informed consent.
排除标准
- •(1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) < 23;
- •(2) took antianxiety drugs;
- •(3) with taVNS contraindications;
- •(4) received VNS treatment during the past month;
- •(5) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.
结局指标
主要结局
change of Hamilton Anxiety Scale Score
时间窗: Assessed at baseline, one day post intervention，2 weeks post intervention
Hamilton Anxiety Scale (HAM-A score), which was used for assessing the degree of anxiety. It consists of 14 symptomatic definition elements, with a total possible score of 56. The differences in HAMA score before and after treatment can be used to evaluate the effect of taVNS treatment.
次要结局
- change of HbO2 in the prefrontal cortex(Assessed at baseline, one day post intervention)
- change of Unified Parkinson's Disease Rating Scale Score section III(Assessed at baseline, one day post intervention，2 weeks post intervention)
- change of Unified Parkinson's Disease Rating Scale Score section I(Assessed at baseline, one day post intervention，2 weeks post intervention)
研究者
Kezhong Zhang
professor，Chief physician
The First Affiliated Hospital with Nanjing Medical University