NCT07276035

Brief Summary

The goal of this study is to determine whether stimulation of the brain-stomach connection can influence stomach activity in healthy adults and in individuals suffering from chronic nausea. The main questions it aims to answer are:

  • What are the best brain sites to influence the stomach?
  • What are the effects of different stimulation patterns on stomach activity?
  • Does the stimulation affect the sensation of nausea in participants suffering from chronic nausea? Researchers will use a non-invasive method of brain stimulation called Transcranial Magnetic Stimulation (TMS) and will record stomach responses with skin electrodes on the abdomen. Participants will:
  • Visit the clinic at least once, and for up to 9 times more over the course of several months.
  • Receive TMS while sitting in a chair similar to a dentist's chair.
  • Drink water or consume a test meal during each study visit.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
63mo left

Started Jan 2026

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Jul 2031

First Submitted

Initial submission to the registry

November 25, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2031

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

November 25, 2025

Last Update Submit

January 29, 2026

Conditions

Chronic Nausea and Vomiting Syndrome

Keywords

Chronic unexplained nausea and vomiting

Outcome Measures

Primary Outcomes (2)

  • GMEP location

    Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot

    Baseline session

  • EGG power change

    Change in spectral power of the EGG in the 3 cpm frequency band associated with the gastric filling task (water load or test meal), either followed or not by neuromodulatory rTMS

    Each study session through study completion, up to 1 year

Secondary Outcomes (3)

  • GMEP amplitude

    Each study session through study completion, up to 1 year

  • Volume

    Each study session through study completion, up to 1 year

  • Nausea severity (only participants suffering from chronic nausea)

    Each study session through study completion, up to 1 year

Study Arms (1)

Healthy subjects and CNVS subjects

EXPERIMENTAL

Subjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS)

Device: Transcranial Magnetic Stimulation, TMS

Interventions

Transcranial Magnetic Stimulation, TMSDEVICE

The best location for evoking an electromyographic (EMG) response of the first dorsal interosseus (FDI) muscle in left and right hand to stimulation of the primary (M1) motor cortex and the minimum stimulation intensity required to evoke a certain EMG response amplitude (Motor Threshold, MT) are determined. This serves as a reference to determine the best location and stimulation parameters to evoke GMEPs from M1 and pre-motor cortical areas. After identification of the GMEP hot-spot, a stomach filling task (water load test or test meal) is administered and changes in the electrogastrogram (EGG) are monitored. In subsequent study visits, the stomach filling task is preceded by application of neuromodulatory repetitive TMS (rTMS), targeted to the GMEP hotspot.

Healthy subjects and CNVS subjects

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults between ages 21-60 years old, with and without CNVS diagnosis per self-report.

You may not qualify if:

  • body mass index (BMI) \> 30
  • pregnancy or intention to become pregnant
  • past or present chemotherapy
  • diagnosis of gastric (stomach) cancer
  • any kind of gastric (stomach) surgery
  • current use of GLP-1 receptor agonists (e.g. Ozempic, Trulicity)
  • medications which significantly lower seizure thresholds (e.g. bupropion (Wellbutrin), fluoxetine (Prozac), or tramadol (Ultram))
  • implantable devices, such as a pacemakers or nerve stimulators
  • history of head injury that required hospitalization, metal in the skull, or neurologic disease such as stroke, history of seizures or history of syncope (fainting or passing out)
  • neurodegenerative disease (Multiple Sclerosis, Parkinson's or Alzheimer's Disease)
  • ongoing psychosis or altered cognitive status status (e.g. hearing sounds or seeing visions that are not there, or feeling confused or suffering from memory lapses)
  • history of cardiovascular (i.e., heart attack), pulmonary (i.e., need for supplemental oxygen), or endocrine disease (e.g. diabetes)
  • current enrollment in another study using Transcranial Magnetic Stimulation (TMS)
  • current use of drugs such as amphetamines, methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or drinking 3 or more alcoholic drinks per day
  • For healthy subjects only: chronic history of gastrointestinal symptoms (e.g., nausea, indigestion, bloating, abdominal pain)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • David J Levinthal, MD PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul HM Kullmann, PhD

CONTACT

412-647-1533phmk@pitt.edu

David J Levinthal, MD PhD

CONTACT

412-303-0525levinthald@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 10, 2025

Study Start

January 28, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2031

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Final analytic de-identified datasets will be deposited in the SPARC data repository.

Time Frame
Datasets will be deposited within 2 years of study completion for as long as the SPARC repository is active.
Access Criteria
The SPARC repository is publicly accessible.

Locations

US(1)