Clinical Trial: fMRI and Visceral Perception Upon Capsaicin Infusion

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Brain and Brainstem Activation Following Duodenal Nociceptive Stimulation With Capsaicin, an Exploratory High-resolution fMRI Study in Healthy Volunteers

Brief Summary: Brain imaging has shown abnormal brain activations in response to visceral stimulation in patients with the Irritable Bowel Syndrome (IBS). To investigate the possible role of the Nucleus of the Solitary Tract (NTS), the primary relay station in the brainstem for vagal afferents, its activation in IBS and functional dyspepsia patients will be evaluated. Prior to this, an exploratory study in healthy volunteers will be conducted. This will be the first high magnetic field fMRI study evaluating the possible role of NTS activation in visceral abdominal pain. Moreover, this will be the first fMRI study using duodenal capsaicin infusion as a chemical stimulus, which is more physiological than mechano-stimulation.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome:

  • Activation of the Nucleus of the Solitary Tract [ Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    the BOLD (Voxel-wise blood oxygenation level dependent) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo
  • Activation of the Nucleus of the Solitary Tract [ Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    the functional ASL (arterial spin labelling) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Activity and connectivity in the Cingulate Cortex, Insula, Thalamus, Prefrontal Cortex, Primary and Secondary Somatosensory Cortex, Amygdala, PAG [ Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    the functional ASL and BOLD signal activity in the above-mentioned brain structures during capsaicin infusion compared to placebo
  • Questionnaire for pain (Visual Analogue Scores) [ Time Frame: During capsaicin and placebo infusion between t=0 and and t=60 minutes ]
    Scores range from 0 [no pain] to 10 [worst possible pain].
  • Questionnaire for depression and anxiety [ Time Frame: During the test day, before scanning ]
    Hospital Anxiety and Depression Scale (HADS)
  • Questionnaire for depression [ Time Frame: During the test day (= day 1), before scanning ]
    PHQ-9 scores
  • Questionnaire for personality trait [ Time Frame: During the test day (= day 1), before scanning ]
    BIG FIVE Inventory
  • Questionnaire for quality of life [ Time Frame: During the test day (= day 1), before scanning ]
    SF-36 (quality of life) scores
  • Questionnaire for current affent scores [ Time Frame: During the test day (= day 1), before scanning ]
    PANAS-SF (current affect) scores
  • Questionnaire for current pain [ Time Frame: During the test day (= day 1), before scanning ]
    Brief Pain Inventory (BPI) scores
  • Microbiota [ Time Frame: Subjects will provide a fecal sample on the test day (= day 1) ]
    different bacteria in stool
  • Questionnaire for anxiety [ Time Frame: During the test day (= day 1), before scanning ]
    GAD-7 scores
  • Questionnaire for the assessment of Gastrointestinal symptom scores [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the GSRS and the GSRS-IBS
  • Questionnaire for the assessment of early life traumata [ Time Frame: During the test day (= day 1), before scanning ]
    Scores of the ETISR-SF


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: August 25, 2015
Date Started: February 2016
Date Completion: December 2016
Last Updated: March 17, 2016
Last Verified: March 2016