Vagal Nerve Stimulation for Interoception Modulation

Massachusetts General Hospital25 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Adult

Interventions

taVNSDEVICE

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

Sham taVNSDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Neuroimaging

NTS connectivity

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

Gastric Function

MRI-derived measures of gastric accommodation

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.