Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 26, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called auricular transcutaneous vagal nerve stimulation (taVNS) to see how it affects patients with functional dyspepsia and gastroparesis. Functional dyspepsia is a condition that causes discomfort in the upper stomach, while gastroparesis is when the stomach takes too long to empty its contents. The goal is to understand how this treatment impacts both the brain and stomach symptoms for these patients.

If you are between the ages of 18 and 65 and have been diagnosed with either functional dyspepsia or gastroparesis, you might be eligible to participate. Healthy volunteers are also welcome. Participants will undergo an MRI and will need to avoid alcohol, nicotine, and caffeine for 24 hours before the study. Throughout the study, you will continue your regular medical treatment. It's important to know that certain conditions, like a history of gastric surgery or having a pacemaker, may exclude you from participating. If you join, you can expect a supportive environment where your health and safety are prioritized.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Volunteers, female and male, between 18 and 65 years of age.
• • 2. For healthy volunteers, ability to undergo MRI for up to 2 hours.
• • 3. For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
• 4. For Gastroparesis patients, diagnosis will include the following criteria:
• • symptoms of gastroparesis of at least 12 weeks duration (does not have to be continuous) with varying degrees of nausea, vomiting, early satiety, and/or post-prandial fullness
• • an idiopathic etiology
• • abnormal gastric emptying scintigraphy (GES) results using a 4 hour low fat Egg Beaters® protocol within the last 6 months with either a gastric emptying rate \> 60% retention at 2 hours and/or \>10% retention at 4 hours.
• • 4) Stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month before study and during the study period.
• • 5) Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session.
• Exclusion Criteria:
• • 1. History gastric/esophageal surgery
• • 2. Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
• • 3. Illicit drugs or opioid use.
• • 4. History of arrhythmias.
• • 5. Implanted pacemaker.
• • 6. Epilepsy or a prior history of seizures.
• • 7. For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
• • 8. Pregnancy or nursing or plans to become pregnant.
• • 9. Inability to provide informed consent.
• • 10. BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table).
• 11. 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 will require additional 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
• • IUD
• • Hearing Aid
• • Dentures (which might create NMR artifacts)
• • Metal Injury to eyes
• • Pregnancy or plans to become pregnant
• • Breast Feeding
• • Meniere's Disease
• • Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control)
• • Claustrophobia