The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Depression in PD (PD-D-taVNS)
Transcutaneous Auricular Vagus Nerve Stimulation Alleviates Depressive Symptoms in Patients With Parkinson's Disease and Depression During Verbal Fluency Tasks
研究概览
地位
条件
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Kezhong Zhang
- 电话号码：13770840575
- 邮箱：kezhong_zhang1969@126.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
This study recruited right-handed subjects from the Department of Neurology, Huai'an Second People's Hospital. The inclusion criteria for patients with PD and depression were as follows: diagnosis of idiopathic Parkinson's disease based on the clinical diagnostic criteria of the Movement Disorder Society; diagnosis of depressive disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Hamilton Depression Rating Scale (HAMD) score ≥ 8; stable medication regimens for Parkinson's disease for at least one month prior to enrollment; aged 40 to 80 years; and voluntary participation with written informed consent. In addition, age- and gender-matched non-depressed PD patients and healthy controls were enrolled to further compare brain functional characteristics among different groups.
Exclusion Criteria:
presence of cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score < 23; ongoing use of antidepressant medications; presence of contraindications related to transcutaneous auricular vagus nerve stimulation (taVNS); receipt of vagus nerve stimulation (VNS) treatment within the past month; and comorbid severe neurological, renal, cardiovascular or hepatic diseases.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：real Transcutaneous auricular vagus nerve stimulation
Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
Active Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.Sham Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.
The stimulation paradigm was identical to that of the real stimulation group.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
|
假比较器：Sham Transcutaneous auricular vagus nerve stimulation
Two modified dot-like electrodes delivered the stimulation to the left earlobe.
Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.
Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
Two modified dot-like electrodes delivered the stimulation to the left earlobe.
Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.
Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change of Hamilton Depression Scale Score
大体时间：Assessed at baseline, one day post intervention,2 weeks post intervention
|
Hamilton Depression Scale (HAM-D score), which was used for assessing the degree of Depression.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment
|
Assessed at baseline, one day post intervention,2 weeks post intervention
|
|
change of Hamilton Depression Scale Score Hamilton Anxiety Scale (HAM-D score), which was used for assessing the degree of anxiety.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment
大体时间：Assessed at baseline, one day post intervention#2 weeks post intervention
|
Assessed at baseline, one day post intervention#2 weeks post intervention
|
合作者和调查者
调查人员
- 研究主任：Kezhong Zhang、China, Jiang Su the First Affiliated Hospital of Nanjing Medical University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2026-06
- The First Affiliated Hospital (其他标识符：The First Affiliated Hospital with Nanjing Medical University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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