Status:
ACTIVE_NOT_RECRUITING
Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Purdue University
National Institutes of Health (NIH)
Conditions:
Gastroparesis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ha...
Eligibility Criteria
Inclusion
- HEALTHY VOLUNTEERS
- • Healthy volunteers from 18 to 65 years of age
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04282317
Start Date
August 1 2019
End Date
December 31 2026
Last Update
April 12 2024
Active Locations (1)
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1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202