Sickness Behavior Clinical Trial
Official title:
Inflammation Och hjärnfunktion - Huvudstudie
NCT number | NCT03551184 |
Other study ID # | 2010/1363-32 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | March 2011 |
Verified date | May 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Healthy subjects Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm University, Swedish Council for Working Life and Social Research, Swedish Heart Lung Foundation, The Swedish Research Council, The Swedish Society of Medicine, University of California, San Francisco |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Brain function | 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. |
7.5 hours | |
Secondary | Self-rated health | "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 |
4.5 hours | |
Secondary | Facial appearence | Photos were taken under standardised conditions before and after injection | 2 h |
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