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临床试验/NCT02796625
NCT02796625已完成不适用

Development of a Reliable Neurophysiological Pain Assessment Tool: Alpha as a Predictive Biomarker

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Peak Alpha Frequency (Hz)

研究概览

简要总结

The investigators will use non-invasive recordings of brain activity to measure pain as a proxy to self-report. Participants will undergo testing for about 3 hours on two separate days. The testing will involve experiencing painful heat.

详细描述

Neurophysiological investigations of pain have suggested that electroencephalograph (EEG) measures of peak alpha frequency might provide a means of pain assessment. In healthy subjects, increased peak alpha frequency is strongly correlated with pain self-reports after exposure to acute noxious heat. Conversely, chronic pain patients compared to healthy control display decreased peak alpha frequencies higher in alpha power. Measures of peak alpha frequency also show a negative relationship with disease duration, suggesting that peak alpha frequency may not only index ongoing pain but also disease progression. The overall aim is to determine the predictive accuracy, reliability, and specificity of EEG alpha activity in acute pain and a model of neuropathic pain in healthy subjects.

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
21 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Able to speak, read, and write English
  • Between 21 and 44 years of age
  • Able to understand and willing to comply with all study procedures and is available for the duration of the study
  • Free of an acute or chronic pain condition
  • Not history of psychiatric or neurologic condition

排除标准

  • Unable to undergo EEG, assessed on an individual basis
  • History of unstable major psychiatric disorder (self-report)
  • History of chronic pain (self-report)
  • More than 14 alcoholic drinks per week on average (self-report)
  • Active [within 6 months] substance or alcohol abuse (self-report and urine toxicology)
  • Use of opioids (self-report and urine toxicology)
  • History of major depressive disorder (self-report)
  • Pregnant or Lactating (women only), based on (self-report and urine test)
  • Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
  • Uncontrolled (systolic blood pressure > 175 mmHg or diastolic blood pressure >105 mmHg) or unstable hypertension

结局指标

主要结局

Peak Alpha Frequency (Hz)

时间窗: pain-free and pain states at the baseline visit

The highest power of EEG-based alpha activity in the 8-12Hz frequency range, calculated using the center of gravity method.

次要结局

  • Alpha Wave Activity Reliability(alpha activity at pain-free and pain states, assessed at a second visit following the first visit by at least 3 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Seminowicz

Associate Professor, Department of Neural and Pain Sciences

University of Maryland, Baltimore

研究点 (2)

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