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临床试验/NCT01409538
NCT01409538已完成1 期

Brain Imaging and Pain: Analysis of Placebo Analgesia

University of Florida2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Brain Imaging Results

研究概览

简要总结

This study examines the brain activation associated with placebo pain reduction.

详细描述

This study is a basic science study of the mechanisms of placebo analgesia in asymptomatic healthy individuals. Each participant receives a baseline pain testing session, followed by a conditioning paradigm that results in expectation of pain relief and conditioning. They then undergo functional magnetic resonance imaging during either placebo (conditioned analgesia) or baseline. To examine order effects and habituation, the participants also either undergo a repeated placebo or a repeated baseline. The primary dependent measures in the study are the fMRI determined regions of interest, in a network of brain areas associated with pain processing. The anticipated outcome of the study is the alteration of network connectivity between sensory, affective, evaluative areas of the brain associated with placebo.

Because this is not a traditional clinical trial, there are not traditional efficacy criteria, rather the outcomes are changes in brain function from manipulations of patient expectation and classical conditioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • at least 18 years of age
  • english speaking

排除标准

  • pain condition

结局指标

主要结局

Brain Imaging Results

时间窗: 2 weeks from baseline

This outcomes represents the neural network underpinnings of the placebo analgesic response. It is the result of a network analysis using structural equation modeling of fMRI determined brain activations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Brain Imaging and Pain: Analysis of Placebo Analgesia | 临床试验