Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Brain-Gut MRI and Vagal Nerve Stimulation in Diabetic Gastroparesis Patients and Healthy Adults
Enrollment for this study is expected to close on Wednesday, December 3, 2025
Overview
What we are studying
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. This study aims to determine how a form of neuromodulation, transcutaneous vagus nerve stimulation, which is non-invasive and non-painful, affects human brain and autonomic activity in healthy adults and participants with diabetic gastroparesis. We will accomplish this by combining whole-brain functional MRI (fMRI) methodologies with MRI of the stomach and physiological monitoring.
This study will comprise of 1 brief virtual screening visit, followed by up to 4 functional magnetic resonance imaging (fMRI) brain-brain and gut scanning visits located in the Charlestown Navy Yard at the Athinoula A. Martinos Center for Biomedical Imaging (CNY 149), all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
The screening visit will take ~30 minutes, and the imaging visits will take ~2 hours each. Compensation will be up to $400 in total, and parking will be reimbursed for all visits.
Why it is important
What we hope to accomplish
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Principal Investigator
Project Contact
Click I Am Interested "I Am Interested" "I Am Interested" to get started. If you have questions, contact:
Andrew Bolender
Clinical Research Coordinator
Who can participate
Inclusion Criteria: 1) Between 18 and 65 years of age. 2) No GI diagnoses OR Gastroparesis diagnosis including following criteria: a) symptoms of Gastroparesis of at least 12 weeks duration (does not have to be continuous) with variety degress of nausea, vomiting, early satiety, and/or post-prandial fullness, b) a diabetic etiology, and c) abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters protocol within the last 6 months with either a gastric emtying rate >60% retention at 2 hours and/or >10% retention at 4 hours.3) Stable medical treatment for FD patients during 1 month before study and during the study period. 3) If gastroparesis: Stable medical treatment for FD or GP during 1 month before study and during the study period. 4) An ability to remain still in an MRI machine for two hours. 5) Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study visit.
Healthy Volunteers
Healthy volunteers are eligible for this study
Healthy volunteers must not have any chronic GI symptoms.
Who cannot participate
Exclusion Criteria: 1) Subjects will be excluded if they have had previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency or iron overload disorders. 2) Subjects with an estimated Glomerular Filtration Rate (eGFR) <60 will be excluded from the study. 3) Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 3 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI’s, TCA’s) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the PI whether subjects on anti-depressants will be able to participate in the study. 4) Subjects with diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy will be excluded. 5) Any alternative treatment (e.g. acupuncture, hypnosis, CBT etc.) for FD two weeks prior to the study or during the study period. 6) Illicit drugs or opioid usage. 7) History of arrhythmias. 8) Implanted pacemaker. 9) Epilepsy or a prior history of seizures. 10) Pregnancy or nursing or plans to become pregnant. 11) Inability to provide informed consent. 12) BMI more than 32 and/or weight > 235 lbs. 13) Allergy to pineapple. 14) Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject’s medical history. Subjects with the following characteristics/disease may not be eligible to participate in the study and are subject to further safety screening: -History of Head Trauma -Any metallic implants (e.g. braces or permanent retainers) -Tattoos with metallic ink above the nipple line -Surgical Aneurysm Clips -Cardiac Pacemaker -Prosthetic Heart Valve -Neurostimulator -Implanted pumps -Cochlear Implants -Metal rods, Plates -Screws -Recent Previous Surgery -copper IUD -Hearing Aid -Dentures (which might create NMR artifacts) -Metal Injury to eyes -Breast Feeding -Meniere's Disease -Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control) -Claustrophobia
What you may be asked to do
During imaging visits, participants may be asked to consume lactose-free pineapple pudding before entering the MRI scanner. Imaging visits will require fasting the night before the visit beginning at 10pm. The vagus nerve stimulation will occur during some imaging visits and consists of two small electrodes being placed on one ear.
Project activities may include:
- Survey
- Office visit
- MRI scan
Estimated Time Commitment
9 hours over 5 sessions
What You May Get
Compensation will be up to $400 in total, and parking will be reimbursed for all visits.
Location
Athinoula A. Martinos Center for Biomedical Imaging
CNY 149 13th St, Charlestown, MA 02129
Travel
- Parking reimbursed
Travel and Parking Details
Additional Information
Study Phase
Phase 1: This project studies the safety of a medication or treatment, usually on healthy volunteers. It examines the medication or treatment’s effects on the body and looks for side effects.
Funding Source
- NIH or Other Federal