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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282317
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborators:
Purdue University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
John M. Wo, Indiana University School of Medicine

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

Condition or disease Intervention/treatment Phase
Gastroparesis Other: MRI scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Magnetic Resonance Imaging of the Brain and the Upper Gastrointestinal Tract in Healthy Volunteers and Patients With Gastroparesis
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Healthy Volunteer
This arm will enroll healthy volunteers as controls
Other: MRI scan
MRI scan

Gastroparesis Subjects
This arm will enroll a) patients with gastroparesis from type 1 diabetes and b) patients with gastroparesis from vagus nerve trauma
Other: MRI scan
MRI scan




Primary Outcome Measures :
  1. Gastric peristalsis [ Time Frame: Baseline ]
    Compare 3D gastric peristalsis progression before & after test meals in healthy volunteers and patients with gastroparesis


Secondary Outcome Measures :
  1. Contraction frequency [ Time Frame: Baseline ]
    Compare colored 3-D heat map of stomach contraction frequency before & after test meals in healthy volunteers and patients with gastroparesis

  2. Pylorus transit [ Time Frame: Baseline ]
    Compare pylorus mean opening diameter before & after test meals in healthy volunteers and patients with gastroparesis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

HEALTHY VOLUNTEERS

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.
  • Unable to give own informed consent.

GASTROPARESIS PATIENTS

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282317


Contacts
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Contact: Anita Gupta, MBBS,MPH 3179489227 anigupta@iu.edu
Contact: Fred Hermann 317-278-9293 fhermann@iu.edu

Locations
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United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Anita Gupta, MBBS, MPH    317-948-9227    anigupta@iu.edu   
Contact: Fred Hermann, BS    317-278-9293    fhermann@iu.edu   
Principal Investigator: John M Wo, MD         
Sub-Investigator: Kristine M Mosier, MD         
Sponsors and Collaborators
Indiana University School of Medicine
Purdue University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: John M Wo, MD Indiana University School of Medicine
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Responsible Party: John M. Wo, Director of GI Motility and Neurogastroenterology Unit, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT04282317    
Other Study ID Numbers: MRI study
OT2OD023847 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John M. Wo, Indiana University School of Medicine:
Gastroparesis
functional MRI
Gastric MRI
Brain MRI
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms