Mapping the Effect of (neuro)inflammation on Stress Sensitivity in the Brain of Healthy Men

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Inflammation, Stress, Healthy Volunteer

In brief

The goal of this interventional study is to determine the effects of inflammation on stress responses in the brain of healthy men. In order to achieve this goal, participants are injected with an inflammation-inducing agent, then observed inside a brain scanner.

Key facts

Study ID

NCT06620679

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

20

Starts

2024-05-03

Expected to finish

2026-12-31

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male
• Healthy
• Age 18-45 years
• BMI 18.5-25 kg/m2
• Proficient in English and/or Dutch

You may not qualify if…

• Have previous or current neuropsychiatric disorders or have history of major head trauma
• Have any disorder, which in the Investigator's opinion might jeopardise your safety or compliance with the study
• Have any prior or current treatment(s) that might jeopardise your safety or that would compromise the integrity of the study
• Have any prior and recent medication use (especially antibiotics, cardiovascular drugs, steroids, non-steroid anti-inflammatory drugs, centrally effective drugs)
• Are participating in an interventional Trial with an investigational medicinal product (IMP) or device
• Have current or previous infection or vaccination within the last 8 weeks
• Have pathological values of blood indices and certain genetic profiles that will affect brain imaging results (we will conduct a blood screening before starting the study)
• Had strong physical activity (e.g. swimming, football, running more than 8 km per hour, carrying heavy loads) 24h before the start of the experiment.
• Are a smoker
• Are a night-shift worker
• Have recent or previous use of psychotropics within the last year
• Have regular high alcohol use (>4 drinks/week)
• Have any brain imaging contraindications:
• Have claustrophobia or too much uneasiness in limited spaces (in order to tolerate confinement during the scanning procedures).
• Have severe back problems that will interfere with lying on your back in the scanner with no movement for long durations.
• Have any condition that would interfere with MRI studies (e.g., cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, and metallic body inclusion or other metal implanted in the body). To check this, you will need to fill out a checklist before the procedure.
• You and/or your partner is planning to become pregnant during and up to one month of the completion of the study

Where it is running

• UZ/KU Leuven — Leuven, Flemish Brabant, Belgium (enrolling)

Full record on ClinicalTrials.gov

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