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Search / Trial NCT04762836

Pain, Learning, and Nocebo

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Feb 16, 2021

Trial Information

Current as of August 11, 2025

Completed

Keywords

Nocebo Pain Bold F Mri Conditioning

ClinConnect Summary

Main outcome variable:

- The magnitude of induced nocebo hyperalgesia is defined as the difference in pain ratings for the first nocebo trial compared to the first control trial of the extinction phase.

A significant difference here is assessed within the mixed model analysis of variance (ANOVA), comparing within-subjects differences for control and nocebo trials between DCS and placebo groups.

Time frame: On the day of the experimental session, during the extinction phase

Secondary outcome variables:

* The difference in BOLD response at a series of a priori ROIs between pharmacologica...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged 18 - 35 years
  • Good understanding of the English language
  • Normal or corrected to normal vision
  • Exclusion Criteria:
  • A potential participant who meets any of the following exclusion criteria will be excluded from participation in this study:
  • 1. History of serious or chronic medical or psychiatric conditions (e.g., convulsions (epilepsy), cardiovascular problems, depression; careful and detailed screening will be carried out for both medical and psychiatric conditions)
  • 2. History of chronic pain or itch conditions
  • 3. Experiencing pain or itch of 1 or more on a 0-10 pain / itch NRS on the day of testing
  • 4. Currently using antihistamines, analgesic medication, or itch-reducing medication (in the 24 hours prior to testing)
  • 5. Use of psychotropic drugs (including recreational drugs such as cannabis and psychotropic prescription-medication; in the past month)
  • 6. Currently being (or intending to become) pregnant, or currently breastfeeding, or planning to father a child in the next 3 months
  • 7. Colour-blindness
  • 8. Body Mass Index under 16 or over 30
  • 9. Meeting any exclusion criteria in the fMRI examination questionnaire which would prohibit fMRI scanning.
  • 10. Having too high of a threshold for pain (where high pain cannot be induced with temperatures lower than 49.5 °C).

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Leiden, South Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Andrea WM Evers, PhD

Principal Investigator

Leiden University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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