Brain-Stomach Circuits in Chronic Nausea

Conditions

• Chronic Nausea and Vomiting Syndrome

Eligibility Criteria

Sex

ALL

Age

21 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• Transcranial Magnetic Stimulation, TMS — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jan 28, 2026

Status verified

Jan 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2031

Study Design

Enrollment

219 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Healthy subjects and CNVS subjects
  Subjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS)

Primary Outcome Measure

GMEP location [ Time Frame: Baseline session ]

Central Contacts

• Paul HM Kullmann, PhD
  412-647-1533
  [email protected]
• David J Levinthal, MD PhD
  412-303-0525
  [email protected]

Locations (1)

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