Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    70
  • sponsor
    Indiana University School of Medicine
Updated on 24 January 2021
nausea
early satiety
gastric disorder

Summary

The study is to lay the groundwork for non invasive imaging of the GI tract and the brain gut interaction

Description

Magnetic resonance imaging (MRI) produces non-invasive exquisite spatial resolution of internal organs. However, its application to the GI tract has been limited by several challenges. The GI tract has a complex and convoluted geometry. The GI geometry changes slowly over the course of meal digestion, as well as rapidly due to contraction of various compartments of the GI tract. As a person takes natural breaths during MRI, the respiratory motion further complicates the acquisition and analysis of GI images. In addition, different types of meal or nutrients have variable property as image contrast in upper GI MRI. It is difficult to standardize the MRI analysis for accurate and quantitative assessment of gastric emptying, motility, absorption, and secretion, to name a few. In a recently published study by our research collaborators at Purdue University, they have addressed many of these challenges in rodents and are ready to refine and translate their technical solutions to human upper GI MRI.

Functional MRI of the brain has been used to study afferent response in various GI disorders, such as dysphagia, functional dyspepsia, and irritable bowel syndrome.1-3 Brain activity is altered in the emotional response areas, and activity is reduced in the areas associated with top-down modulation of visceral afferent signals.4 However, direct correlation between regional brain activation by functional-MRI and GI motility by meal-contrast MRI is lacking.

The outcome of the proposed research is expected to lay the groundwork for non-invasive imaging of GI anatomy and function and the brain-gut interaction towards better understanding, diagnosis, prevention, and treatment of GI disorders.

Details
Condition Gastroparesis, Gastroparesis, Diabetic Gastroparesis, Gastropathy, Stomach Discomfort, Stomach Discomfort, Diabetic Gastroparesis, delayed gastric emptying, gastric atony
Treatment MRI scan
Clinical Study IdentifierNCT04282317
SponsorIndiana University School of Medicine
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with gastroparesis from 18 to 65 years of age
Symptoms of gastroparesis of at least 12 weeks duration with varying degrees of nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain
Abnormal 4-hour gastric emptying scintigraphy within the last 6 months >60% retention at 2 hrs and/or >10% retention at 4 hrs

Exclusion Criteria

Contraindication to MR scanning: pregnancy, implanted gastric stimulator, neural stimulator, implanted cardiac pacemaker, auto-defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), pain pump, insulin pump or any pre-existing eye conditions
Prior diagnosis of the upper GI disorders other than gastroparesis, including gastric or duodenal ulcer, gastric outlet obstruction, acute or chronic pancreatitis, large hiatal or paraesophageal hernia, small intestinal bacterial overgrowth, celiac disease, Crohn's disease
Prior brain or abdominal surgery (except cholecystectomy or appendectomy)
Prior diagnosis of central nervous system illness, neurological lesion, a psychiatric history, or recurrent migraines that require medication
Uncontrolled medical problems, such as hypertension, pulmonary or airway disease, heart failure, or coronary artery disease
Allergy to pineapple
Prior history of dysphagia
Unable to give own informed consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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