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NCT Number: NCT07276035

Brain-Stomach Circuits in Chronic Nausea

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location status: Recruiting

About this study

This study will use cutaneous recordings of stomach activity (electrogastrogram, EGG) and non-invasive brain stimulation with Transcranial Magnetic Stimulation (TMS) to

  • map descending cerebral cortical-to-stomach circuitry via gastric motor-evoked potentials (GMEPs),
  • use repetitive TMS (rTMS) applied to GMEP hotspots to modulate the stomach response to a satiety task (water load or nutrient drink/meal),
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • For CNVS subjects only: diagnosis of gastric motility disorder (e.g. gastroparesis/slow stomach emptying) or history of bowel obstruction (i.e., chronic partial small bowel obstruction)

Treatment and study plan

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.

Primary outcomes

  1. GMEP location

    Time frame: Baseline session

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

  2. EGG power change

    Time frame: Each study session through study completion, up to 1 year

    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

Secondary outcomes

  1. GMEP amplitude

    Time frame: Each study session through study completion, up to 1 year

    Amplitude of GMEPs at hotspot

  2. Volume

    Time frame: Each study session through study completion, up to 1 year

    Volume consumed during the gastric filling task

  3. Nausea severity (only participants suffering from chronic nausea)

    Time frame: Each study session through study completion, up to 1 year

    Nausea severity rating on an 11-point (0-10) Likert-scale (0=none, 10=worst possible)

Study contacts

Contact information is provided by the study sponsor or research team.

David J Levinthal, MD PhD

CONTACT

[email protected]

412-303-0525

Elijah D Wright

CONTACT

[email protected]

412-647-1228

Sponsors and collaborators

Lead sponsor

David Levinthal

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Dec 10, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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