Maastricht University Medical Center
Maastricht, 6229 ER, Netherlands
NCT Number: NCT02551029
Brain imaging has shown abnormal brain activations in response to visceral stimulation in patients with the Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD). 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 (7T) evaluating the possible role of NTS activation in visceral abdominal pain. Moreover, this will be the first pharmacological fMRI study using duodenal capsaicin infusion as a chemical stimulus, which is more physiological than mechano-stimulation in the upper gastrointestinal tract.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Maastricht, 6229 ER, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Capsaicin oleoresina solution infusion into the duodenum.
Other names: Saline infusion into the duodenum
Time frame: During duodenal capsaicin and placebo infusion between t=0 and and t=38 minutes
the BOLD (Voxel-wise blood oxygenation level dependent) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo
Time frame: During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes
the functional BOLD signal activity in the above-mentioned brain structures during capsaicin infusion compared to placebo
Time frame: During capsaicin and placebo infusion between t=0 and and t=38 minutes
Scores range from 0 [no pain] to 10 [worst possible pain].
Time frame: During the test day, before scanning
Hospital Anxiety and Depression Scale (HADS). Has 14 items (7 for depression, 7 for anxiety) with a 4 points likert scale (0-3). Scores for depression and anxiety range from 0-21 and studies identified 8 as the cutoff-point.
Time frame: During the test day (= day 1), before scanning
PHQ-9 scores (patient health questionnaire). The questionnaire has 9 items with a 4 points likert scale (0-3) and a total score of 27. A total score of 0-4 indicates none to minimal depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Time frame: During the test day (= day 1), before scanning
BIG FIVE Inventory, the Big Five Inventory (BFI) survey that measures the big five dimensions of personality (extraversion, neuroticism, consciousness, agreeableness, and openness to experience). The questionnaire has 44 items.
Time frame: During the test day (= day 1), before scanning
SF-36 (quality of life) scores, The Short Form (36) Health Survey questionnaire of 36 items, scale 1-6, generates a physical and a mental QoL component summary.
Time frame: During the test day (= day 1), before scanning
PANAS-SF (current affect) scores, Positive and Negative Affect Schedule. This is a 20 item questionnaire (scale 1-5) total scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Time frame: During the test day (= day 1), before scanning
Brief Pain Inventory (BPI) scores, The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub- items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Time frame: During the test day (= day 1), before scanning
GAD-7 scores, for screening and severity measuring of generalized anxiety disorder (GAD). GAD-7 has seven items, 0-3 scale.
Time frame: During the test day (= day 1), before scanning
Scores of the GSRS, scale 1-7, generates subscores for abdominal pain, reflux, diarrhea, constipation, indigestion
Time frame: During the test day (= day 1), before scanning
Scores of the GSRS-IBS, scale 1-7, generates subscores for abdominal pain, bloating, constipation, diarrhea, satiety.
Time frame: During the test day (= day 1), before scanning
Scores of the ETISR-SF, The Early Trauma Inventory Self Report - Short Form comprises of 27 items, divided into four dimensions (general trauma, physical abuse, emotional abuse and sexual abuse) and scored on a dichotomous scale (Yes/No).
Time frame: During the test day (= day 1), before scanning
Scores of the Visceral Sensitivity Index, a 15 item questionnaire, scale 1-6, assesses gastrointestinal (GI)-specific anxiety.
Maastricht University Medical Center
Other
Brain and Brainstem Activation Following Duodenal Nociceptive Stimulation With Capsaicin, an Exploratory High-resolution fMRI Study in Healthy Volunteers
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