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临床试验/NCT03612258
NCT03612258已完成不适用

Brain Mechanisms of Altered Sensory Perception and Self-Referential Processing in Juvenile Fibromyalgia

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2018年2月28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
153
试验地点
2
主要终点
Functional brain activation differences

研究概览

简要总结

This study evaluates whether differences exist between adolescent females with juvenile-onset fibromyalgia and healthy controls in processing of pain and emotion at the neural level as assessed by functional magnetic resonance imaging (fMRI). The study includes a longitudinal component to evaluate changes in neural processing of pain and emotion before and after different treatment strategies.

详细描述

Juvenile-onset fibromyalgia (JFM) is a chronic, widespread pain condition that primarily affects females. Previous work has shown increased sensitivity to painful and non-painful sensory stimuli in adults with fibromyalgia, as well as brain processing abnormalities associated with these stimuli. These abnormalities in adults are highly predictive of fibromyalgia status (as opposed to healthy status) in adults. Although JFM has some similar symptoms and features to fibromyalgia in adults, the neural mechanisms of JFM may be partially different, given the moment of sharp brain development characterising JFM. fMRI scans will be completed before and after different treatments for JFM (e.g. neuromuscular training + cognitive behavioral therapy, graded aerobic exercise) to investigate the effects of treatment on brain measures related to pain, fatigue and emotion processing.

研究设计

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

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of Juvenile Fibromyalgia (by a pediatric rheumatologist or pain physician using 2010 American College of Rheumatology criteria)
  • Right handed
  • Functional Disability Index score ≥ 7, indicating at least mild disability
  • Stable medication regimen for 3 weeks prior to MRI scan

排除标准

  • Non-MRI compatible metal objects in the body (including braces, permanent upper retainers)
  • Comorbid rheumatic disease (e.g. juvenile arthritis, systemic lupus erythematosus)
  • Major psychiatric diagnoses (e.g. bipolar disorder, obsessive compulsive disorder, schizophrenia) or documented developmental delay
  • Taking opioid pain medication

结局指标

主要结局

Functional brain activation differences

时间窗: Baseline

Functional Magnetic Resonance Imaging: differences in pain processing and emotional processing relative to healthy controls

次要结局

  • Functional brain activation differences(Baseline and 8 weeks)

研究者

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

Robert Coghill

Professor

Children's Hospital Medical Center, Cincinnati

研究点 (2)

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