Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis
Running, not enrolling · Not applicable
Conditions studied: Gastroparesis
In brief
The study is to lay the groundwork for non invasive imaging of the GI tract and the brain gut interaction
Key facts
- Study ID
- NCT04282317
- Run by
- Indiana University
- People needed
- 31
- Starts
- 2019-08-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy volunteers from 18 to 65 years of age
You may not qualify if…
- 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.
Where it is running
- Indiana University School of Medicine — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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