跳至主要内容
临床试验/NCT03551184
NCT03551184已完成不适用

Inflammation Och hjärnfunktion - Huvudstudie

Karolinska Institutet0 个研究点目标入组 52 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
主要终点
Pain sensitivity (cutaneous and deep)

研究概览

简要总结

In this randomized double blind study, 52 healthy participants were injected with either 0.6 ng/kg body weight or placebo to test if changes in pain sensitivity is associated with change in neural activity using BOLD MR scanning.

详细描述

52 healthy participants were included in this randomized double blind study. Participants were injected once, and randomized to injection with with the active component or placebo. Participants were recruited by advertising and screened through questionnaires and a health examination by a physician. They were asked not to engage in strenuous physical activities, sleep regular hours and refrain from alcohol the day before the experiment. If the participants felt ill, e.g. coming down with a cold, they were instructed to call and were rescheduled for a later appointment. C-reactive protein (CRP) was assessed to exclude participants having an ongoing infection on the experimental day. Pregnancy was also an exclusion criteria and a pregnancy test was administered for all female participants on arrival. Pain sensitivity measures were tested at baseline and at peak inflammatory response 1-2 hours after injection. Both deep and cutaneous pain at threshold and suprathreshold noxious levels were tested. Heat- and cold (cutaneous) pain sensitivity was assessed for threshold stimuli and intense noxious stimuli, as well as pressure (deep) pain thresholds and CPM (descending pain inhibition). These tests were conducted while the participants were in the MR-scanner to investigate neural correlates to change in pain sensitivity. Subjects filled out questionnaires at baseline, 90 minutes, 3.5 and 5 hours after injection.

The study and the procedures used in the study are described in detail here: https://openarchive.ki.se/xmlui/bitstream/handle/10616/44650/Thesis_Bianka_Karshikoff.pdf?sequence=8\&isAllowed=y

The following papers using data from this study is published:

Lindstedt F, Karshikoff B, Schalling M, Olgart Hoglund C, Ingvar M, Lekander M & Kosek E. Serotonin-1A Receptor Polymorphism (rs6295) Associated with Thermal Pain Perception. PLOS ONE. 2012;7(8):e43221. Epub 2012/09/07.

Karshikoff B, Jensen KB, Kosek E, Kalpouzos G, Soop A, Ingvar M, Olgart Höglund C, Lekander M, Axelsson J. Why sickness hurts: A central mechanism for pain induced by peripheral inflammation. Brain, Behavior, and Immunity 2016 Oct;57:38-46.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy subjects

排除标准

  • •Diagnosed physiological or psychiatric disease
  • •Needle anxiety or blood phobia
  • •Regular medication (excluding contraceptive pill)
  • •Infection in the last two weeks
  • •Pregnancy or breastfeeding
  • •Excessive alcohol use
  • •Body mass index in the range of obesity (>30 kg/m2) or underweight (<18.5 kg/m2)
  • •Invisible veins in the antecubital area of the arms
  • •Known or risk of metal inserted in body
  • •Claustrophobic tendensies

研究组 & 干预措施

Endotoxin

Active Comparator

Endotoxin 0.6 ng/kg body weight injection

干预措施: Endotoxin (Biological)

Placebo

Placebo Comparator

Saline injection

干预措施: Placebo (Biological)

结局指标

主要结局

Pain sensitivity (cutaneous and deep)

时间窗: 7.5 hours

Both deep and cutaneous pain at threshold and suprathreshold noxious levels. Heat- and cold (cutaneous) pain sensitivity was assessed for threshold stimuli and intense noxious stimuli, as well as pressure (deep) pain thresholds and CPM (descending pain inhibition).

Brain function

时间窗: 7.5 hours

BOLD activity from MR scans 1. Functional connectivity of the insular cortex during acute inflammation, in relation to symptoms of sickness. 2. Changes in central pain mechanism during acute inflammation, assessed as activity in the insula and areas of the descending pain inhibitory pathways in the brain. 3. Changes in brain function during an emotional task with an interoceptive component during acute inflammation.

次要结局

  • Facial appearence(2 h)
  • Self-rated health(4.5 hours)

研究者

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

Mats Lekander

Professor

Karolinska Institutet

相似试验

Inflammation and Brain Function - Main Study | 临床试验