Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

Early Phase 1

Recruiting

• Conditions: Dyspepsia; Gastroparesis

• Registration Number: NCT03603730
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Explore the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in functional dyspepsia and gastroparesis patients.

Detailed Description

The primary aims of this study are to 1) investigate the effects of auricular transcutaneous vagal nerve stimulation (taVNS) on brain-gut signaling using a liquid meal test in functional dyspepsia (FD) and gastroparesis (GP) patients using combined gastric, autonomic and neuroimaging measures, and 2) evaluate the effectiveness of taVNS on FD and GP symptoms.

A total of 25 FD and 25 GP patients will be enrolled in this study, both females and males, ranging between 18 and 65 years of age. There will be multiple study visits consisting of a screening, baseline testing, consumption of a liquid meal, and fMRI brain and gut imaging sessions. Visits will include active and inactive taVNS delivered to the outer ear at a moderate, non-painful level.

Study Timeline

• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-07-27
• Study Start: 2018-11-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-06-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Neuroimaging	2 hours	Functional magnetic resonance imaging (fMRI)

Secondary Outcome Measures

Name	Time	Method
Electrogastrography (EGG)	2 hours	We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
Respiration	2 hours	Respiration will be measured in beats per minute (bpm).
Electrocardiography (ECG)	2 hours	We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex.
Skin Conductance Levels (SCL)	2 hours	SCL will measured in volts per second.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States