Mapping and stimulating brain–stomach connections in chronic nausea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses transcranial magnetic stimulation (TMS) while recording stomach electrical activity with surface electrodes (electrogastrogram, EGG) to identify brain sites that influence the stomach. Researchers will map gastric motor-evoked potentials (GMEPs), apply repetitive TMS to identified hotspots, and measure stomach responses during a satiety task (water load or nutrient drink/meal). Participants include adults with chronic nausea and healthy controls who will attend up to ten in-person visits over several months. Clinical, demographic, and autonomic data (for example EKG) will be collected as covariates to interpret differences between groups.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: David J Levinthal, MD PhD — University of Pittsburgh
• Study coordinator: Elijah D Wright
• Email: edw87@pitt.edu
• Phone: 412-647-1228

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.