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Clinical Trials/NCT04282317
NCT04282317
Active, not recruiting
Not Applicable

Magnetic Resonance Imaging of the Brain and the Upper Gastrointestinal Tract in Healthy Volunteers and Patients With Gastroparesis

Indiana University School of Medicine1 site in 1 country31 target enrollmentAugust 1, 2019
ConditionsGastroparesis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastroparesis
Sponsor
Indiana University School of Medicine
Enrollment
31
Locations
1
Primary Endpoint
Gastric peristalsis
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John M. Wo

Director of GI Motility and Neurogastroenterology Unit

Indiana University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers from 18 to 65 years of age

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.
  • Presence of gastroparesis symptoms, such as nausea, emesis, early satiety, effortless regurgitation, post-prandial fullness and pain, and/or postprandial epigastric pain.
  • Prior diagnosis of the upper GI disorders, including gastroparesis, 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 systemic disorders associated with GI neuromuscular disorder listed in Appendix B.
  • Taking medications that can effect GI motility, including opiate, metoclopramide, dopamine agonist for Parkinson or restless leg syndrome, anticholinergics.
  • 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.
  • Presence of dysphagia.

Outcomes

Primary Outcomes

Gastric peristalsis

Time Frame: Baseline

Compare 3D gastric peristalsis progression before \& after test meals in healthy volunteers and patients with gastroparesis

Secondary Outcomes

  • Pylorus transit(Baseline)
  • Contraction frequency(Baseline)

Study Sites (1)

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