NCT00200889

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1 healthy

Timeline
25mo left

Started Aug 2023

Longer than P75 for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Aug 2023Jun 2028

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
17.9 years until next milestone

Study Start

First participant enrolled

August 22, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

4.9 years

First QC Date

September 13, 2005

Last Update Submit

October 22, 2025

Conditions

Healthy

Keywords

AcupunctureMagnetic Resonance Imaging, FunctionalBrain Mappinghealthy volunteersNeuromodulationgastric MRI

Outcome Measures

Primary Outcomes (2)

  • Brain activity during functional magnetic resonance imaging (fMRI)

    Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS

    1 hour

  • Stomach activity during gastric magnetic resonance imaging (MRI)

    Gastric accommodation and sensitivity change between active and inactive auricular tVNS

    30 minutes

Secondary Outcomes (4)

  • Electrogastrography (EGG)

    2 hours

  • Electrocardiography (ECG)

    2 hours

  • Respiration

    2 hours

  • Skin Conductance Levels (SCL)

    2 hours

Study Arms (2)

Congruent

EXPERIMENTAL

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

Device: active TEAS

Incongruent

EXPERIMENTAL

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

Device: active TEAS

Interventions

active TEASDEVICE

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

CongruentIncongruent

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18-65
  • Functional dyspepsia

You may not qualify if:

  • Any condition contraindicating an fMRI brain scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Study Officials

  • Vitaly Napadow, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Bolender, B.A.

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants are not made aware of the expectation manipulation nor their group assignment until the end of the final visit, at which point they are debriefed. Outcomes assessors will be blind to group assignments until analysis is complete.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be randomized 1:1 to "Congruent" or "Incongruent" briefing groups. The Congruent group receives briefings including expectations of stimulation effects on gastric motility consistent with prior research in the literature. The Incongruent group receives briefings including expectations of stimulation effects on gastric motility inconsistent with prior research in the literature.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

August 22, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

October 24, 2025

Record last verified: 2025-10

Locations

US(1)