Assessing the Physiologic Effect of taVNS During a Cold Pressor Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Mean Heart Rate (Before CPT/taVNS)
研究概览
简要总结
This study explores the use of transcutaneous auricular vagus nerve stimulation (taVNS), a new form of neuromodulation which stimulates the ear. 24 healthy subjects without a past medical or psychiatric history will be recruited to participate in a phone screen followed by 1 lab visit. During the lab visit, subjects will participate twice in a validated stress induction technique called the cold pressor test, while concurrently receiving either active or sham taVNS. The cold pressor test consists of subjects placing their feet in an ice bath for a short period of time. Researchers will measure participant's heart rate while they receive taVNS (ear stimulation) and participate in the cold pressor test. Assessments of mood, anxiety, and stress will be collected at the beginning and end of the visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 18-65 years
- •English speaking
- •Non-treatment-seeking community members
排除标准
- •Diagnosis of COVID-19 in the past 14 days
- •Facial or ear pain or recent ear trauma.
- •Metal implant devices in the head, heart or neck.
- •History of brain stimulation or other brain surgery.
- •History of myocardial infarction or arrhythmia, bradycardia.
- •Use of B-blockers, antiarrhythmic medication (sodium/potassium/calcium-channel blockers), or blood pressure medications.
- •Active respiratory disorder.
- •Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
- •Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
- •Individuals suffering from frequent/severe headaches.
- •Individuals with a reported history of any mental health disorder or taking any psychotropic medications.
- •Moderate to severe alcohol or substance use disorder.
- •Pregnancy
结局指标
主要结局
Mean Heart Rate (Before CPT/taVNS)
时间窗: Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation)
Heart rate will be measured with EKG electrodes before concurrent stress test and ear stimulation.
Mean Heart Rate (After CPT/taVNS)
时间窗: After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation)
Heart rate will be measured with EKG electrodes after concurrent stress test and ear stimulation.
Mean Heart Rate (During CPT/taVNS)
时间窗: During concurrent stress test and ear stimulation (average duration of 5 minutes)
Heart rate will be measured with EKG electrodes during concurrent stress test and ear stimulation.
次要结局
- Mean Score of Pain (Before CPT/taVNS)(Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation))
- Mean Score of Pain (After CPT/taVNS)(After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation))
- Mean Score of Anxiety (During CPT/taVNS)(During concurrent stress test and ear stimulation (average duration of 5 minutes))
- Mean Score of Pain (During CPT/taVNS)(During concurrent stress test and ear stimulation (average duration of 5 minutes))
- Mean Score of Anxiety (Before CPT/taVNS)(Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation))
- Mean Score of Anxiety (After CPT/taVNS)(After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation))
- Mean Score of Distress (Before CPT/taVNS)(Baseline (up to 10 minutes prior to concurrent stress test and ear stimulation))
- Mean Score of Distress (During CPT/taVNS)(During concurrent stress test and ear stimulation (average duration of 5 minutes))
- Mean Score of Distress (After CPT/taVNS)(After concurrent stress test and ear stimulation (up to 10 minutes after concurrent stress test and ear stimulation))
研究者
Christopher Austelle
Principal Investigator
Medical University of South Carolina