Brain and brainstem activation following duodenal nociceptive stimulation with capsaicin, an exploratory high-resolution fMRI study in healthy volunteers.
- Conditions
- Irritable Bowel Syndrome (IBS)1001797710002861
- Registration Number
- NL-OMON47774
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
* Of female sex;
* Based on medical history and previous examination, no gastrointestinal
complaints can be defined;
* Age between 18 and 65 years;
* BMI between 18 and 30 kg/m2;
* Women in fertile age (<55 years old) must use contraception or be
postmenopausal for at least two years;
* All subjects should be right-handed.
* Presence of metallic prostheses, pacemakers, metal clips on blood vessels,
metal parts in the eye, an intrauterine device, metal braces, facial tattoos
(including permanent eye make-up) and/or other metal objects;
* History of major head trauma or head/brain surgery;
* History of claustrophobia;
* History of severe or chronic cardiovascular, respiratory, urogenital,
gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes,
nose, throat), dermatological/connective tissue, musculoskeletal,
metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy,
major surgery and/or laboratory assessments which might limit participation in
or completion of the study protocol;
* Use of medication, including vitamin and iron supplementation, except oral
contraceptives, within 14 days prior to start of the study;
* Major abdominal surgery interfering with gastrointestinal function
(uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and
other surgery upon judgment of the principle investigator);
* Pregnancy, lactation, wish to become pregnant;
* High alcohol consumption (>15 alcoholic consumptions per week);
* Using drugs of abuse;
* Self-admitted HIV-positive state;
* Known allergic reaction to capsaicin;
* High intake of spicy (capsaicin containing) food (meaning an estimated intake
of > than 1.5mg/day), due to possible desensitization of the capsaicin receptor
TRPV1 (see further below);
* Administration of investigational drugs or participation in any scientific
intervention study which may interfere with this study (to be decided by the
principle investigator), in the 180 days prior to the study;
* Any evidence of structural brain abnormalities examined by anatomical MRI
will lead to exclusion.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(ASL-) Voxel-wise blood oxygenation level dependent (BOLD) signal activity in<br /><br>the NTS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Voxel-wise blood oxygenation level dependent BOLD signal activity in the<br /><br>Cingulate Cortex, Insula, Thalamus, Prefrontal Cortex, Primary and Secondary<br /><br>Somatosensory Cortex, Amygdala, PAG<br /><br>* Baseline Cerebral Blood Flow<br /><br>* Visual Analogue Scores during capsaicin and placebo infusion into the duodenum<br /><br>* Gastro-intestinal Symptom Scores, Depression and Anxiety symptom scores<br /><br>(HADS, PHQ-9, GAD-7), personality trait (BIG-FIVE-Inventory), Traumata in early<br /><br>life, quality of life scores (SF-36), current affect scores (PANAS-SF), current<br /><br>pain scores (BPI-SF) and gastrointestinal symptom scores (GSRS-IBS+), visceral<br /><br>sensitivity index (VSI)</p><br>