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临床试验/NCT04241562
NCT04241562已完成不适用

Validation of a Novel Cortical Biomarker Signature for Pain

University of Maryland, Baltimore2 个研究点 分布在 2 个国家目标入组 159 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
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

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

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

David Seminowicz

Associate Professor

University of Maryland, Baltimore

研究点 (2)

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