Neural Responses to Tactile Auricular Stimulation Measured by Functional Near-infrared Spectroscopy in Pain-free Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- fNIRS response, Lumbar spine vs. thumb auricular points
研究概览
简要总结
This is a single-visit non-invasive study of healthy volunteer subjects. Brain activity will be measured with infra-red light sensors attached to a cap worn on the head, while both ears are gently stimulated with plastic filaments.
详细描述
The aim of this study is to localize and quantify brain activations from experimental stimulation of auricular points in pain-free volunteers. Investigators will stimulate auricular points for the shoulder, thumb, and lumbar spine with von Frey filaments and measure functional near-infrared spectroscopy (fNIRS) responses in the primary somatosensory (S1) and prefrontal cortex (PFC). This will test the hypothesis that stimulation across different points in the auricular cartography maps to distinct brain responses, an assumption underpinning AT theory. Stimulation of different ear points is anticipated to induce similar PFC responses, but activate distinct areas within the S1 homunculus, validating the concept of auricular cartography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of at least 18 years
排除标准
- •frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months,
- •history or symptoms of neuropathy,
- •active lesions or skin disruptions to either ear,
- •recent (< 3 mo) illicit drug use,
- •history of substance misuse/abuse,
- •current or recent (<1 month) opioid or marijuana use, and
- •current regular use of psychoactive prescription medications
研究组 & 干预措施
Auricular stim with fNIRS
Points on the ear that correspond to the the shoulder, thumb, and lumbar spine (within an accepted cartography for auriculotherapy) will be stimulated repeatedly with flexible plastic (von Frey) filaments. A functional near-infrared spectroscopy cap will be worn, and brain responses to the stimulation will be recorded.
干预措施: auricular stimulation (Other)
结局指标
主要结局
fNIRS response, Lumbar spine vs. thumb auricular points
时间窗: 10 minutes
Calculated T-statistic for contrast of analyzed fNIRS signal change, comparing responses from stimulation of the ipsilateral ear at the auricular points corresponding to the lumbar-spine vs. thumb. A T-statistic of 0 indicates no difference; more positive scores mean stronger fNIRS signal change with stimulation of the lumbar point, compared to stimulation of the thumb point; more negative scores mean change with stimulation of the thumb, compared to the lumbar spine. This outcome is a number reflecting the overall magnitude of difference between stimulation points, calculated in one summary statistic. Dispersion measures cannot be calculated for the T-statistic in this analysis framework.
次要结局
- fNIRS response, shoulder vs. thumb auricular points(10 minutes)
- fNIRS response, lumbar spine vs. shoulder auricular points(10 minutes)
研究者
Keith M Vogt
Associate Professor of Anesthesiology & Perioperative Medicine and Bioengineering
University of Pittsburgh