Efficacy Of Auricular Transcutaneous Vagus Nerve Stimulation In Treating Chronic Dizziness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Dizziness Handicap Inventory (DHI) score
研究概览
简要总结
The purpose of this study is to measure the change in dizziness, as measured by change in Dizziness Handicap Inventory (DHI) score, following a 4-week treatment period with auricular transcutaneous vagus nerve stimulation (aTVNS).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75, Persistent Postural-Perceptual Dizziness (PPPD) diagnosis per International Classification of Vestibular Disorders (ICVD).
- •Persistent dizziness ≥3 months and at least 1 dizziness exacerbation/day during 2-week run-in.
- •On stable medications/therapy for ≥4 weeks prior to baseline (if any).
排除标准
- •Uncompensated peripheral/central vestibular deficit, sensory-afferent or cerebellar ataxia.
- •Cardiac disease (coronary disease, unstable arrhythmia), recurrent syncope (>1 in past 12 months).
- •Neck surgery, vagotomy, or any condition interfering with vagal stimulation.
- •Pregnancy.
研究组 & 干预措施
Auricular transcutaneous vagus nerve stimulation
The vagus nerve stimulation group will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of auricular transcutaneous vagus nerve stimulation. This arm will continue using the active treatment for 8 weeks.
干预措施: Auricular transcutaneous vagus nerve stimulation (Other)
Sound sham electrodes
The sham control group will will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of daily stimulation using the sham device. After 4 weeks, the sham control group will begin active auricular transcutaneous vagus nerve stimulation for 4 weeks.
干预措施: Sham Device (Other)
Sound sham electrodes
The sham control group will will perform two sessions per day (morning and evening), each lasting approximately 30 minutes, for a total of 1 hour of daily stimulation using the sham device. After 4 weeks, the sham control group will begin active auricular transcutaneous vagus nerve stimulation for 4 weeks.
干预措施: Auricular transcutaneous vagus nerve stimulation (Other)
结局指标
主要结局
Change in Dizziness Handicap Inventory (DHI) score
时间窗: Baseline, 4 weeks
The Dizziness Handicap Inventory (DHI) is a 25-item questionnaire assesses physical, emotional, and functional aspects of dizziness. Each of the 25 questions has three answers: "Always" (4 points), "Sometimes" (2 points), or "No" (0 points). Scores are summed for a total from 0 (no disability) to 100 (maximum disability).
次要结局
- Change in Anxiety (HADS-A)(Baseline, 4 weeks and 8 weeks)
- Change in Postural Sway(Baseline, 4 weeks and 8 weeks)
- Weekly averages of dizzy-day frequency(Through end of study, approximately 8 weeks)
研究者
Colton T. Clayton
Principal Investigator
Mayo Clinic