Vagal Nerve Stimulation for Interoception Modulation

NCT03603730 | Completed

• 2 other identifiers: 2010P000440K01AT012208
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

• Neuroimaging

  NTS connectivity

  Visits 1,2,3 (2 hours)

• Gastric Function

  MRI-derived measures of gastric accommodation

  Visits 1,2,3 (2 hours)

Study Arms (2)

taVNS

EXPERIMENTAL

Active taVNS

Device: taVNS

Sham

SHAM COMPARATOR

Sham taVNS

Device: Sham taVNS

Interventions

taVNS DEVICE

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

taVNS

Sham taVNS DEVICE

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

Sham

Eligibility Criteria

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

You may qualify if:

• Male and female patients aged 18 and 65 years old (inclusive)
• Comprehension of instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Roberta Sclocco, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 27, 2018
• Study Start: July 11, 2023
• Primary Completion: September 24, 2025
• Study Completion: March 31, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)