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| ID | Type | Description | Link |
|---|---|---|---|
| NL51770.068.15 | Other Identifier | CCMO | |
| METC 152048 | Other Identifier | METC Azm/UM |
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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duodenal capsaicin infusion | Experimental | Through a naso-duodenal tube, a capsaicin solution will be infused into the duodenum. |
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| Placebo (saline) | Placebo Comparator | Through a naso-duodenal tube, a saline solution will be infused into the duodenum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Other |
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| |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of the Nucleus of the Solitary Tract | the BOLD (Voxel-wise blood oxygenation level dependent) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo | During duodenal capsaicin and placebo infusion between t=0 and and t=38 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Activity and connectivity in the Cingulate Cortex, Insula, Thalamus, Prefrontal Cortex, Primary and Secondary Somatosensory Cortex, Amygdala, PAG | the functional BOLD signal activity in the above-mentioned brain structures during capsaicin infusion compared to placebo | During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A.A.M. Masclee, Prof. MD. PhD | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | 6229 ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34799534 | Derived | Beckers AB, van Oudenhove L, Weerts ZZRM, Jacobs HIL, Priovoulos N, Poser BA, Ivanov D, Gholamrezaei A, Aziz Q, Elsenbruch S, Masclee AAM, Keszthelyi D. Evidence for engagement of the nucleus of the solitary tract in processing intestinal chemonociceptive input irrespective of conscious pain response in healthy humans. Pain. 2022 Aug 1;163(8):1520-1529. doi: 10.1097/j.pain.0000000000002538. Epub 2021 Nov 15. |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003109 | Colonic Diseases, Functional |
| D004415 | Dyspepsia |
| D005767 | Gastrointestinal Diseases |
| D015746 | Abdominal Pain |
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Placebo |
| Other |
|
|
| Questionnaire for pain (Visual Analogue Scores) | Scores range from 0 [no pain] to 10 [worst possible pain]. | During capsaicin and placebo infusion between t=0 and and t=38 minutes |
| Questionnaire for depression and anxiety | 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. | During the test day, before scanning |
| Questionnaire for depression | 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. | During the test day (= day 1), before scanning |
| Questionnaire for personality trait | 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. | During the test day (= day 1), before scanning |
| Questionnaire for quality of life | 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. | During the test day (= day 1), before scanning |
| Questionnaire for current affect scores | 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. | During the test day (= day 1), before scanning |
| Questionnaire for current pain | 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. | During the test day (= day 1), before scanning |
| Questionnaire for anxiety | GAD-7 scores, for screening and severity measuring of generalized anxiety disorder (GAD). GAD-7 has seven items, 0-3 scale. | During the test day (= day 1), before scanning |
| Questionnaire for the assessment of Gastrointestinal symptom scores | Scores of the GSRS, scale 1-7, generates subscores for abdominal pain, reflux, diarrhea, constipation, indigestion | During the test day (= day 1), before scanning |
| Questionnaire for the assessment of Gastrointestinal symptom scores | Scores of the GSRS-IBS, scale 1-7, generates subscores for abdominal pain, bloating, constipation, diarrhea, satiety. | During the test day (= day 1), before scanning |
| Questionnaire for the assessment of early life traumata | 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). | During the test day (= day 1), before scanning |
| Questionnaire for the assessment of gastrointestinal specific anxiety | Scores of the Visceral Sensitivity Index, a 15 item questionnaire, scale 1-6, assesses gastrointestinal (GI)-specific anxiety. | During the test day (= day 1), before scanning |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D059226 | Nociceptive Pain |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |