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

NCT04282317 | Active Not Recruiting DMC

• 2 other identifiers: MRI studyOT2OD023847
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroparesis

Keywords

Gastroparesis; functional MRI; Gastric MRI; Brain MRI

Outcome Measures

Primary Outcomes (1)

• Gastric peristalsis

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

  Baseline

Secondary Outcomes (2)

• Contraction frequency

  Baseline

• Pylorus transit

  Baseline

Study Arms (2)

Healthy Volunteer

OTHER

This arm will enroll healthy volunteers as controls

Other: MRI scan

Gastroparesis Subjects

OTHER

This arm will enroll a) patients with gastroparesis from type 1 diabetes and b) patients with gastroparesis from vagus nerve trauma

Other: MRI scan

Interventions

MRI scan OTHER

MRI scan

Gastroparesis Subjects; Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Purdue University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• John M Wo, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of GI Motility and Neurogastroenterology Unit

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: February 24, 2020
• Study Start: August 1, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (1)