Vagal nerve stimulation for treating stomach issues

Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation

This study is testing if a new treatment using vagal nerve stimulation can help people with stomach problems like functional dyspepsia and gastroparesis feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT03603730 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on patients with functional dyspepsia and gastroparesis. It aims to understand how taVNS influences brain-gut signaling through a liquid meal test, utilizing various gastric, autonomic, and neuroimaging measures. A total of 50 participants, aged 18 to 65, will undergo multiple visits that include screening, baseline testing, and fMRI imaging sessions while receiving either active or inactive taVNS. The study seeks to evaluate the effectiveness of this intervention on the symptoms of these gastrointestinal conditions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with functional dyspepsia or gastroparesis meeting specific criteria.

Not a fit: Patients with non-idiopathic gastroparesis or those unable to undergo MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive treatment option for patients suffering from functional dyspepsia and gastroparesis.

How similar studies have performed: While the use of vagal nerve stimulation is being explored in various contexts, this specific application for functional dyspepsia and gastroparesis is relatively novel.

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

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Roberta Sclocco, PhD — Spaulding Rehabilitation Hospital
• Study coordinator: Andrew Bolender, BA

Conditions Dyspepsia; Gastroparesis; Functional Dyspepsia