- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02551029
fMRI and Visceral Perception Upon Capsaicin Infusion
June 5, 2020 updated by: Maastricht University Medical Center
Brain and Brainstem Activation Following Duodenal Nociceptive Stimulation With Capsaicin, an Exploratory High-resolution fMRI Study in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maastricht, Netherlands, 6229 ER
- Maastricht University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presence of metallic prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye, an intrauterine device, metal braces, tattoos 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Duodenal capsaicin infusion
Through a naso-duodenal tube, a capsaicin solution will be infused into the duodenum.
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Other Names:
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Placebo Comparator: Placebo (saline)
Through a naso-duodenal tube, a saline solution will be infused into the duodenum.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activation of the Nucleus of the Solitary Tract
Time Frame: During duodenal capsaicin and placebo infusion between t=0 and and t=38 minutes
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the BOLD (Voxel-wise blood oxygenation level dependent) signal activity in the Nucleus of the Solitary Tract during capsaicin infusion compared to placebo
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During duodenal capsaicin and placebo infusion between t=0 and and t=38 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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the functional BOLD signal activity in the above-mentioned brain structures during capsaicin infusion compared to placebo
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During duodenal capsaicin and placebo infusion between t=0 and and t=60 minutes
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Questionnaire for pain (Visual Analogue Scores)
Time Frame: During capsaicin and placebo infusion between t=0 and and t=38 minutes
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Scores range from 0 [no pain] to 10 [worst possible pain].
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During capsaicin and placebo infusion between t=0 and and t=38 minutes
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Questionnaire for depression and anxiety
Time Frame: During the test day, before scanning
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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.
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During the test day, before scanning
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Questionnaire for depression
Time Frame: During the test day (= day 1), before scanning
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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.
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During the test day (= day 1), before scanning
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Questionnaire for personality trait
Time Frame: During the test day (= day 1), before scanning
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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.
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During the test day (= day 1), before scanning
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Questionnaire for quality of life
Time Frame: During the test day (= day 1), before scanning
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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.
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During the test day (= day 1), before scanning
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Questionnaire for current affect scores
Time Frame: During the test day (= day 1), before scanning
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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.
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During the test day (= day 1), before scanning
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Questionnaire for current pain
Time Frame: During the test day (= day 1), before scanning
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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.
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During the test day (= day 1), before scanning
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Questionnaire for anxiety
Time Frame: During the test day (= day 1), before scanning
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GAD-7 scores, for screening and severity measuring of generalized anxiety disorder (GAD).
GAD-7 has seven items, 0-3 scale.
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During the test day (= day 1), before scanning
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Questionnaire for the assessment of Gastrointestinal symptom scores
Time Frame: During the test day (= day 1), before scanning
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Scores of the GSRS, scale 1-7, generates subscores for abdominal pain, reflux, diarrhea, constipation, indigestion
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During the test day (= day 1), before scanning
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Questionnaire for the assessment of Gastrointestinal symptom scores
Time Frame: During the test day (= day 1), before scanning
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Scores of the GSRS-IBS, scale 1-7, generates subscores for abdominal pain, bloating, constipation, diarrhea, satiety.
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During the test day (= day 1), before scanning
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Questionnaire for the assessment of early life traumata
Time Frame: During the test day (= day 1), before scanning
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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).
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During the test day (= day 1), before scanning
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Questionnaire for the assessment of gastrointestinal specific anxiety
Time Frame: During the test day (= day 1), before scanning
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Scores of the Visceral Sensitivity Index, a 15 item questionnaire, scale 1-6, assesses gastrointestinal (GI)-specific anxiety.
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During the test day (= day 1), before scanning
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: A.A.M. Masclee, Prof. MD. PhD, Maastricht University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
July 26, 2019
Study Completion (Actual)
July 26, 2019
Study Registration Dates
First Submitted
August 25, 2015
First Submitted That Met QC Criteria
September 14, 2015
First Posted (Estimate)
September 16, 2015
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 5, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Intestinal Diseases
- Nociceptive Pain
- Dyspepsia
- Irritable Bowel Syndrome
- Abdominal Pain
- Gastrointestinal Diseases
- Digestive System Diseases
- Colonic Diseases
- Colonic Diseases, Functional
- Visceral Pain
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- METC 152048 (Other Identifier: METC Azm/UM)
- NL51770.068.15 (Other Identifier: CCMO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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