Recruiting
Early Phase 1

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT00200889

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

active TEAS

Study Details

Brief summary:

This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.

Conditions

Healthy

Study ID

NCT00200889

Start date

Aug 22, 2023

Status verified date

Oct, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults 18-65
  • Functional dyspepsia

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Congruent

Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature.

experimental: Incongruent

Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature.

Interventions

active TEAS

non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg

Primary outcome measure

  • Brain activity during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour ]
  • Stomach activity during gastric magnetic resonance imaging (MRI) [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Andy Bolender, B.A.

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Andy Bolender

abolender@mgh.harvard.edu

Principal Investigator:

Vitaly Napadow, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • Acupuncture
  • Magnetic Resonance Imaging, Functional
  • Brain Mapping
  • healthy volunteers
  • Neuromodulation
  • gastric MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-24.