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Brain-Stomach Circuits in Chronic Nausea

NCT07276035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2026-01-30

No results posted yet for this study

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.

Conditions

  • Chronic Nausea and Vomiting Syndrome

Interventions

DEVICE

Transcranial Magnetic Stimulation, TMS

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • David Levinthal

    lead OTHER

Principal Investigators

  • David J Levinthal, MD PhD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2030-07-31
Completion
2031-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276035 on ClinicalTrials.gov