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Report for Clinical Trial NCT03551184

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Inflammation Och hjärnfunktion - Huvudstudie

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.

NCT03551184 Sickness Behavior
MeSH:Inflammation Illness Behavior

2 Interventions

Name: Endotoxin

Description: Endotoxin at 0.6 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)
Type: Biological
Group Labels: 1

Endotoxin

Name: Placebo

Description: Saline administered intravenously
Type: Biological
Group Labels: 1

Placebo

Primary Outcomes

Description: 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).

Measure: Pain sensitivity (cutaneous and deep)

Time: 7.5 hours

Description: BOLD activity from MR scans Functional connectivity of the insular cortex during acute inflammation, in relation to symptoms of sickness. 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. Changes in brain function during an emotional task with an interoceptive component during acute inflammation.

Measure: Brain function

Time: 7.5 hours

Secondary Outcomes

Description: "How is your health right now?" rated on a 7 point Likert scale at baseline, after 90 minutes and after 4.5 hours. "How do you rate your general state of health?" rated on a 5-point Likert scale at 90 minutes post-injection

Measure: Self-rated health

Time: 4.5 hours

Description: Photos were taken under standardised conditions before and after injection

Measure: Facial appearence

Time: 2 h
Purpose: Basic Science

Allocation: Randomized

Parallel Assignment

There is one SNP

SNPs

1 rs6295

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?seq uence=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.


HPO Nodes