Exploration of the Effect, and Their Duration, of Different Frequency Transcutaneous Auricular Vagal Nerve Stimulation on Sensory Perception.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This study aims to explore the effect of burst-taVNS (electric stimulation of the concha cymba) on tonic (capsaicin-induced skin pain) and acute (pressure pain sensitivity) experimental pain and cardioception. Primary outcomes include pain intensity. Secondary outcomes include sensory thresholds, resting heart rate (EKG), pupillary measurements and conditioned pain modulation.
详细描述
Across 3 visits, each lasting around 2.5hours, burst-taVNS (electrical stimulation of the concha cymba) will be compared to active-control (electrircal stimulation of the earlobe) and sham (no current) stimulation, two gold-standard controls. Assessments of outcomes will occur before capsaicin application and before, twice during and after electrical ear stimulation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Electrodes for the different stimulation conditions will be applied during all three visits regardless of which stimulation is active. Wiring of the electrodes is the same but labelled with 'A' or 'B'. Corresponding stimulation condition will not be known to the experimenter (that is also analyzing the data) until after data analysis.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Speak and understand English
- •18-60 years old.
排除标准
- •Pregnant and/or breastfeeding
- •Regular use of cannabis, opioids or other drugs
- •Current or previous neurologic, musculoskeletal, mental, or other illnesses (e.g., brain or spinal cord injuries, degenerative neurological disorders, major depression, cardiovascular disease, chronic lung disease, etc.)
- •Current regular (once or more a week) use of analgesic medication or other medication which may affect the trial (including paracetamol and NSAIDs)
- •Recent history of acute pain particularly in the lower limbs
- •Abnormally disrupted sleep in 24 hours preceding experiment
- •Contraindications to electric stimulation application (history of epilepsy, metal implants in head or jaw, etc.)
- •Lack of ability to cooperate
- •Contraindications for capsaicin including an intolerance chili consumption and burns or wounds to the application site.
结局指标
主要结局
Pain Intensity
时间窗: From when capsaicin is applied to the end of the experiment in 5 min intervals.
Capaisin is a topically administered tonic pain model. Stemming from its chilly-origin, pain induced ressembels heat/light burning sensation which increases within 20minute of application to the forearm, before it plateaus. Associated pain can be stopped immediately by applying ice/cold water. Participants will be asked to rate (using a scale from 0 denoting no pain, to 10 denoting maximal pain) the intensity of the pain in 5 min time intervals.
次要结局
- Pressure Pain Detection Threshold(Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).)
- Conditioned Pain Modulation Effect(Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).)
- Pressure Pain Perception(Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).)
- Pupillary Light Reflex(Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).)
- Electrocardiography(Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).)
- Cardioception Accuracy(Before Capsaicin application and at 3 time intervals from when the ear stimulation (taVNS, Active Control or Sham) is applied: before, as the stimulation starts and halfway during (at min 20).)
研究者
Laura De Herde
Principle Investigator
Aalborg University