GastroparesisNCT04282317
Magnetic Resonance Imaging of the Brain and Stomach in Healthy Volunteers and Gastroparesis
A study testing MRI scan in people with Gastroparesis, run by Indiana University at 1 site in United States.
Trial summary
The study is to lay the groundwork for non invasive imaging of the GI tract and the brain gut interaction Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers from 18 to 65 years of age
- 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.
Who cannot join
- 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).
Show all 20Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
Official title: Magnetic Resonance Imaging of the Brain and the Upper Gastrointestinal Tract in Healthy Volunteers and Patients With Gastroparesis
The study is to lay the groundwork for non invasive imaging of the GI tract and the brain gut interaction
Read the 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.
- Conditions
- Gastroparesis
- Being tested
- MRI scan
- Keywords
- Gastroparesis, functional MRI, Gastric MRI, Brain MRI
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Other | This arm will enroll healthy volunteers as controls Receives: 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 Receives: Other: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric peristalsis
Compare 3D gastric peristalsis progression before \& after test meals in healthy volunteers and patients with gastroparesis
Measured: Baseline
Secondary outcomes (2)
Contraction frequency
Compare colored 3-D heat map of stomach contraction frequency before \& after test meals in healthy volunteers and patients with gastroparesis
Measured: Baseline
Pylorus transit
Compare pylorus mean opening diameter before \& after test meals in healthy volunteers and patients with gastroparesis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Aug 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, John M. Wo, Indiana University
- Investigators
- John M Wo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282317
- Sponsor's protocol ID
- MRI study
- Other IDs
- OT2OD023847
- Status last verified
- Sep 2025
- First submitted
- 19 Dec 2019
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of the Brain and the Upper Gastrointestinal Tract in Healthy Volunteers and Patients With Gastroparesis
- ClinicalTrials.gov ID
- NCT04282317
- Acronym / sponsor ID
- MRI study
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, functional MRI, Gastric MRI, Brain MRI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Other | Other: MRI scanThis arm will enroll healthy volunteers as controls |
| Gastroparesis Subjects | Other | Other: MRI scanThis arm will enroll a) patients with gastroparesis from type 1 diabetes and b) patients with gastroparesis from vagus nerve trauma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers from 18 to 65 years of age
- 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 exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanMRI scan | Other | Gastroparesis Subjects, Healthy Volunteer |
Primary outcome
Gastric peristalsis
Time frame: Baseline
Compare 3D gastric peristalsis progression before \& after test meals in healthy volunteers and patients with gastroparesis
2 secondary outcomes
Contraction frequency
Time frame: Baseline
Pylorus transit
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Wo, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Gastroparesis, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric peristalsis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.