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临床试验/NCT06025201
NCT06025201招募中不适用

Characterization of Longitudinal EEG Biomarkers in Chronic Low Back Pain

Stanford University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
2
主要终点
Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average

研究概览

简要总结

Chronic low back pain (CLBP) is a pervasive disorder affecting up to one-fifth of adults globally and is the single greatest cause of disability worldwide. Despite the high prevalence and detrimental impact of CLBP, its treatments and mechanisms remain largely unclear. Biomarkers that predict symptom progression in CLBP support precision-based treatments and ultimately aid in reducing suffering. Longitudinal brain-based resting-state neuroimaging of patients with CLBP has revealed neural networks that predict pain chronification and its symptom progression. Although early findings suggest that measurements of brain networks can lead to the development of prognostic biomarkers, the predictive ability of these models is strongest for short-term follow-up. Measurements of different neural systems may provide additional benefits with better predictive power.

Emotional and cognitive dysfunction is common in CLBP, occurring at the behavioral and cerebral level, presenting a unique opportunity to detect prognostic brain-based biomarkers. Likewise, improvements in electroencephalogram (EEG) neuroimaging strategies have led to increased spatial resolution, enabling researchers to overcome the limitations of classically used neuroimaging modalities (e.g., magnetic resonance imaging [MRI] and functional MRI), such as high cost and limited accessibility. Using longitudinal EEG, this patient-oriented research project will provide a comprehensive neural picture of emotional, cognitive, and resting-state networks in patients with CLBP, which will aid in predicting symptom progression in CLBP. Through this award, the investigators will use modern EEG source analysis strategies to track biomarkers at baseline and 1- and 2-month follow-ups and their covariance with markers for pain and emotional and cognitive dysfunction. A 5-month follow up will also be used to only assess patient reported outcomes. In Aim 1, the investigators will identify and characterize differences in resting-state, emotional, and cognitive networks between patients with CLPB and age/sex-matched controls. In Aim 2, the investigators will identify within-subject changes across time and their relationship with clinical symptoms. In Aim 3, as an exploratory aim, the investigators will apply machine- and deep-learning strategies to detect a comprehensive signature of CLBP using EEG features from resting-state, emotional, and cognitive networks.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current diagnosis of Chronic Low Back Pain

排除标准

  • Current diagnosis of cancer
  • Severe psychiatric conditions
  • Pending personal litigation relating to an injury or receiving workers' compensation benefits
  • Being a non-English speaker.

研究组 & 干预措施

Single Arm

Experimental

All participants will complete all interventions

干预措施: Resting State EEG (Behavioral)

Single Arm

Experimental

All participants will complete all interventions

干预措施: Picture Viewing EEG (Behavioral)

Single Arm

Experimental

All participants will complete all interventions

干预措施: Stop Signal EEG (Behavioral)

结局指标

主要结局

Pain Intensity changes from baseline as assessed by the PROMIS current, 7 day maximal and 7 day average

时间窗: Baseline, 1-month, 2-month and 5-month follow-ups

Within subjects change in pain intensity from baseline to each follow up point. Pain intensity measures are 0-10 range with larger numbers indicating more pain

EEG late positive potential changes from baseline

时间窗: Baseline, 1-month and 2-month follow-ups

Within subjects change in late positive potential from baseline to each follow up point.

EEG resting state functional connectivity changes from baseline

时间窗: Baseline, 1-month and 2-month follow-ups

Within subjects change in resting state functional connectivity from baseline to each follow up point.

EEG error related negativity changes from baseline

时间窗: Baseline, 1-month and 2-month follow-ups

Within subjects change in error related negativity from baseline to each follow up point.

次要结局

  • Neuropsychological changes from baseline as assessed by the NIH toolbox(Baseline, 1-month and 2-month follow-ups)

研究者

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

Edward Lannon

Pain Psychologist

Stanford University

研究点 (2)

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