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Completed

NCT Number: NCT03603730

Vagal Nerve Stimulation for Interoception Modulation

Explore the effects of variable ingested volumes and auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in healthy adults.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

We aim to assess and modulate gastric interoception in healthy adults using gastric and brain MRI, different meal volumes (Experiment 1), and transcutaneous auricular vagus nerve stimulation (taVNS) (Experiment 2). MR examinations will precede and immediately follow ingestion of a test meal (containing pineapple, with high manganese content, as a contrast agent), using real-time 3D cine MRI. Subjects will be scanned before ingestion and at 15, 45, and 75 minutes post-meal, in order to extract objective indices of gastric function. Functional MRI (fMRI) brain scans will be alternated to gastric MRI scans. Each subject will undergo 2 separate MRI visits, ingesting different doses of contrast meal in order to peripherally modulate gastric afference (Experiment 1), or receiving sham and active taVNS (Experiment 2), so to modulate visceral afference at the central level.Outcomes will assess the taVNS response of brainstem vagal neurocircuitry, as well as the impact of taVNS on fMRI connectivity patterns (fcMRI) of gastric afference, and link them to MRI-derived gastric outcomes, such as gastric emptying rate, gastric accommodation (fundic volumes), and gastric motility (peristaltic wave propagation).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged 18 and 65 years old (inclusive)
  • Comprehension of instructions
  • Avoidance of alcohol, nicotine, and caffeine for 25 hours prior to study session Exclusion Criteria:
  • BMI (Body Mass Index) more than 32 and/or weight > 235 lbs. (limits of the MRI table)
  • Any other significant medical disease (systemic or CNS), psychiatric disorder, or chronic pain condition/s
  • Epilepsy or a prior history of seizures
  • Psychotropic medications or other medications that effect neurovascular coupling (i.e. fMRI)
  • Subjects taking illicit drugs or opioids
  • Allergy to pineapple (used in the test meal during MRI)
  • 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 will not be eligible to participate in the study: -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) -Non-normally cycling females -Claustrophobia

Treatment and study plan

taVNS

Device

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

Sham taVNS

Device

Sham taVNS delivered to the external ear using zero-current.

Primary outcomes

  1. Neuroimaging

    Time frame: Visits 1,2,3 (2 hours)

    NTS connectivity

  2. Gastric Function

    Time frame: Visits 1,2,3 (2 hours)

    MRI-derived measures of gastric accommodation

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 27, 2018
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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