Vagal Nerve Stimulation for Functional Dyspepsia and Gastroparesis

NCT03603730 | Recruiting

• 1 other identifier: 2010P000440
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dyspepsia; Gastroparesis

Keywords

Functional Dyspepsia; Gastroparesis

Outcome Measures

Primary Outcomes (1)

• Neuroimaging

  Functional magnetic resonance imaging (fMRI)

  2 hours

Secondary Outcomes (4)

• Electrogastrography (EGG)

  2 hours

• Electrocardiography (ECG)

  2 hours

• Respiration

  2 hours

• Skin Conductance Levels (SCL)

  2 hours

Other Outcomes (4)

• Liquid meal challenge

  40 minutes

• Short Form Nepean Dyspepsia Index (SF-NDI)

  5 minutes

• Brief Pain Inventory (BPI)

  5 minutes

Study Arms (1)

taVNS

EXPERIMENTAL

Active or inactive taVNS

Device: taVNS

Interventions

taVNS DEVICE

Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.

taVNS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers, female and male, between 18 and 65 years of age.
• For healthy volunteers, ability to undergo MRI for up to 2 hours.
• For Functional Dyspeptic patients, diagnosis according to the Rome III criteria for both PDS and EPS subtypes.
• 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.
• \) Stable medical treatment for Functional Dyspeptic or Gastroparesis during 1 month before study and during the study period.
• \) Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session.

You may not qualify if:

• History gastric/esophageal surgery
• Any alternative treatment (e.g. acupuncture, hypnosis etc.) two weeks prior to the study or during the study period.
• Illicit drugs or opioid use.
• History of arrhythmias.
• Implanted pacemaker.
• Epilepsy or a prior history of seizures.
• For Gastroparesis patients, inability to comply with or complete GES test (including allergy to eggs).
• Pregnancy or nursing or plans to become pregnant.
• Inability to provide informed consent.
• BMI more than 32 and/or weight \> 235 lbs. (limits of the MRI table).
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Gastroparesis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations

Study Officials

• Roberta Sclocco, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Bolender, BA

CONTACT

617-643-4297; abolender@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 Record Dates

• First Submitted: July 4, 2018
• First Posted: July 27, 2018
• Study Start: November 30, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 27, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)