Validation of a Novel Cortical Biomarker Signature for Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Peak pain intensity from diary ratings
研究概览
简要总结
The study aims to undertake analytical validation of an brain biomarker in healthy participants experiencing a model of sustained temporomandibular pain. The biomarker could detect participants at greater risk of developing more severe pain.
详细描述
Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The investigative team has uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). The biomarker signature combines resting state sensorimotor peak alpha frequency (PAF) measured using electroencephalograph (EEG) and corticomotor excitability (CME) measured using transcranial magnetic stimulation (TMS). This PAF/CME biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). In the current study, the investigators aim to undertake analytical validation of this biomarker in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain (masseter intramuscular injection of nerve growth factor). The investigators will record PAF/CME at multiple time points before and during the development of pain and use online diaries and in-laboratory assessments of pain, sleep, stress, and other psychosocial variables. Specifically, the investigators will test if the biomarker signature predicts an individual's pain sensitivity (high- or low-pain sensitive).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •unable or refusal to provide written consent
- •presence of any acute pain disorder
- •history or presence of any chronic pain disorder
- •history or presence of any other medical or psychiatric compliant
- •use of opioids or illicit drugs in the past 3 months
- •pregnant or lactating women
- •excessive alcohol use
- •contraindicated for TMS (metal implants, epilepsy)
结局指标
主要结局
Peak pain intensity from diary ratings
时间窗: 0 to 30 days following NGF injection
Pain sensitivity
次要结局
- Average Peak daily pain intensity from from diary ratings(0 to 30 days following NGF injection)
- The time between pain onset and complete resolution of pain for two consecutive days(0 to 30 days following NGF injection)
研究者
David Seminowicz
Associate Professor
University of Maryland, Baltimore
