NCT07276035

Brain-Stomach Circuits in Chronic Nausea

TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 219 (estimated)
• Sponsor: David Levinthal · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will use cutaneous recordings of stomach activity (electrogastrogram, EGG) and non-invasive brain stimulation with Transcranial Magnetic Stimulation (TMS) to 1. map descending cerebral cortical-to-stomach circuitry via gastric motor-evoked potentials (GMEPs), 2. use repetitive TMS (rTMS) applied to GMEP hotspots to modulate the stomach response to a satiety task (water load or nutrient drink/meal), 3. assess differences in topography and function of cortical-to-stomach circuitry between healthy subjects and subjects suffering from chronic nausea vomiting syndrome (CNVS). Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on the outcome measures.

Conditions

• Chronic Nausea and Vomiting Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-28
• Primary completion: 2030-07-01
• Completion: 2031-07-01
• First posted: 2025-12-10
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study