Inflammation and Brain Function - Main Study

NCT03551184 | Completed

• 1 other identifier: 2010/1363-32
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sickness Behavior

Keywords

Sickness behavior; Endotoxin; Lipopolysaccharide; Psychoneuroimmunology

Outcome Measures

Primary Outcomes (2)

• Pain sensitivity (cutaneous and deep)

  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).

  7.5 hours

• Brain function

  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.

  7.5 hours

Secondary Outcomes (2)

• Self-rated health

  4.5 hours

• Facial appearence

  2 h

Study Arms (2)

Endotoxin

ACTIVE COMPARATOR

Endotoxin 0.6 ng/kg body weight injection

Biological: Endotoxin

Placebo

PLACEBO COMPARATOR

Saline injection

Biological: Placebo

Interventions

Endotoxin BIOLOGICAL

Endotoxin at 0.6 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)

Also known as: LPS, Lipopolysaccharide

Endotoxin

Placebo BIOLOGICAL

Saline administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects

You may not qualify if:

• Diagnosed physiological or psychiatric disease
• Needle anxiety or blood phobia
• Regular medication (excluding contraceptive pill)
• Infection in the last two weeks
• Pregnancy or breastfeeding
• Smoking
• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• University of California, San Francisco: collaborator
• The Swedish Society of Medicine: collaborator
• Swedish Heart Lung Foundation: collaborator
• The Swedish Research Council: collaborator
• Swedish Council for Working Life and Social Research: collaborator
• Stockholm University: collaborator

MeSH Terms

Conditions

Illness Behavior

Interventions

Endotoxins; Lipopolysaccharides

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Bacterial Toxins; Toxins, Biological; Biological Factors; Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 11, 2018

Record last verified: 2018-05