Vagal Nerve Stimulation for Interoception Modulation | NCT03603730

Studies
Vagal Nerve Stimulation for Interoception Modulation

NCT03603730

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 6, 2026Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Healthy Adult

Interventions

taVNS
Sham taVNS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K01AT012208	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2023Actual

Primary Completion Date

Sep 24, 2025Actual

Completion Date

Mar 31, 2026Actual

First Submitted Date

Jul 4, 2018

First Submission Date that Met QC Criteria

Jul 26, 2018

First Posted Date

Jul 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Name	Class
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
taVNS	Experimental	Active taVNS	Device: taVNS
Sham	Sham Comparator	Sham taVNS	Device: Sham taVNS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
taVNS	Device	Active taVNS delivered to the external ear at a moderate, non-painful level.	taVNS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neuroimaging	NTS connectivity	Visits 1,2,3 (2 hours)
Gastric Function	MRI-derived measures of gastric accommodation	Visits 1,2,3 (2 hours)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided